Institute of Good Manufacturing Practices India

Medical Device Newsletter


Startoon Labs' Pheezee gets USFDA approval

Hyderabad-based startup Startoon Labs Private Limited specializes in medical device research, engineering, and manufacturing, specifically focusing on joint health. The


One BioMed presents X8 HMW DNA Cartridge Kits for automated high molecular weight DNA extraction

One BioMed has launched the X8 HMW DNA Cartridge Kits to automatically extract high molecular weight DNA. These kits enable long-read sequencing and genome assembly. Po


TechInventionLifecare and Reagent IVD Resources collaborate to develop & manufacture novel diagnostics for global health

TechInventionLifecare, a biotech start-up, has partnered with Reagent IVD Resources (RIVDR), a Jaipur-based diagnostics-focused start-up, for the global development and


NEXA negative pressure wound therapy system launched in the USA

AOTI Inc, a privately-owned company based in Oceanside, California, has announced exciting news at the WOCNext conference in Las Vegas. They unveiled their game-changin


Abbott Acquires FDA Clearance for TactiFlex™ Ablation Catheter to Treat Abnormal Heart Rhythm

Abbott has received FDA approval for the TactiFlex™ Ablation Catheter, Sensor Enabled™. It's the world's first flexible-tip ablation catheter with contact f


QuidelOrtho acquires US FDA De Novo classification for two SARS-CoV-2 antibody tests

QuidelOrtho Corporation, a global provider of innovative in vitro diagnostic technologies, has achieved a significant milestone in collaboration with BARDA. The FDA gra


US FDA approves Beta Bionics’ iLet ACE Pump &iLet Dosing Decision Software for individuals six years of age and above with type 1 diabetes

The US Food and Drug Administration (FDA) has approved the Beta Bionics iLet ACE Pump and iLet Dosing Decision Software for type 1 diabetes patients aged six and above.


DrBatra's introduces a 5th generation AI-powered skin analyzer to India for skin treatments

DrBatra's Healthcare, the world's largest homoeopathic clinic chain, introduces AI Skin Pro, an advanced AI-powered device for diagnosing and treating skin diseases.&nb


Lifespin presents Lifespin Amino Acid Profiler

Lifespin GmbH, a medical diagnostics start-up based in Germany and the US, has launched Lifespin Amino Acid Profiler (LAAP), its first commercial product for regulated


CORE Diagnostics establishes a new satellite lab in East Delhi

CORE Diagnostics, a leading provider of advanced diagnostic solutions, has established a satellite lab in East Delhi, Hargobind Enclave. This expansion aims to enhance


Mylab presents a PCR test, PathoDetect HSV Type 1 & 2 Detection kit to detect herpes simplex virus

Mylab Discovery Solutions has launched the PathoDetect HSV Type 1 & 2 Detection kit, which detects and differentiates herpes simplex virus type I (HSV-l) and type 2


US FDA approves Happe Spine's INTEGRATE-C Interbody Fusion System

Medical device company Happe Spine has received FDA 510k clearance for its INTEGRATE-C Interbody Fusion System. The system is the first interbody fusion cage to be full


Quest Diagnostics expands Alzheimer's disease portfolio with new AI-powered test service from uMETHOD Health

Quest Diagnostics has announced the nationwide availability of the RestoreU Dementia Panel, designed to help physicians provide improved care for patients with cognitiv


Cognizant collaborates with Microsoft to bring Microsoft Cloud-based technology apps to the healthcare market

Cognizant and Microsoft have expanded their healthcare collaboration to provide easy access to technology solutions, streamlined claims management, and better interoper


US FDA grants 510(k) approval and CE Mark authorization for Norlase's ECHO Green Pattern Laser

Norlase, a global ophthalmic laser manufacturer, has announced FDA 510(k) clearance and CE Mark approval for ECHO Green Pattern Laser photocoagulator, a portable scanni


GOQii reports a trial phase of a non-invasive innovative diabetic risk monitoring system, GOQii SugarWise

GOQii, a top preventive healthcare company, has commenced the trial phase of its innovative non-invasive diabetic risk monitoring system, named GOQii SugarWise. The com


Bangalore Gastro Centre collaborates with 3BIGS, South Korea, to bring a gut microbiome test kit with AI and data mining

Bangalore Gastro Centre (BGC) has partnered with South Korea's 3BIGS to launch a personalised, end-to-end diagnostic service for digestive disorders in India. BGC claim


Advanced air filtration to accomplish superior air quality to manage the negative health impact of respiratory illnesses

Advanced air filtration is crucial for superior indoor air quality (IAQ) in various settings, combating pollution and respiratory illnesses. Post-pandemic, safety has e


CareDx partners with Miromatrix to extend research using bioengineered organs for human transplantation

CareDx, Inc. and Miromatrix Medical Inc. have partnered to advance the development of fully transplantable human bioengineered organs. CareDx will create an innovative


Roche Diabetes Care's Made in India Accu-Chek meters to boost market presence

RDC India, a division of Roche Diabetes Care, has announced the localization of their blood glucose monitoring device, 'Accu-Chek Active,' in India to enhance diabetes


Smart Toilet Seat Acquires FDA Nod to Monitor Heart Rate

Based in Rochester, NY, Casana has developed an innovative method of measuring heart rate and oxygen saturation using the Heart Seat, a smart toilet. Recently, they obtained FDA clearance for this


GOQii harnesses AI for a smarter technique for preventive healthcare

GOQii, a preventive healthcare company, is integrating four AI-powered features into its platform to provide personalized healthcare solutions to its users. The feature


SK Biopharma's Zero Wired & Zero Earbuds get Red Dot Design Award 2023

SK Biopharmaceuticals' wearable devices, Zero Wired and Zero Earbuds have won the Red Dot Design Award 2023 in the healthcare category for their exceptional design.&nbs


Indian healthcare providers seek the relevance of US FDA Orthopaedic Non-Spinal Bone Plates, Screws and Washers guidance

Indian healthcare providers require Orthopaedic Non-Spinal Bone Plates, Screws, and Washers Premarket Notification (510(k)) Submissions Draft Guidance from the US FDA d


Körber partners with AGU to improve the digital transformation of laboratory workflows and MES in the pharma industry

Körber has added AGU to its Körber Ecosystem Partner program as a “PAS-X MSI Plug & Produce” partner. AGU is a middleware provider that integr


US FDA endows marketing authorization to Moximed’s MISHA Knee System for individuals suffering from knee osteoarthritis

Moximed has received marketing authorization from the US Food and Drug Administration (FDA) for an implantable shock absorber (ISA), the MISHA Knee System, for knee ost


RetinAI collaborates with Boehringer Ingelheim to advance novel treatments using AI for patients with geographic atrophy

RetinAI Medical AG has partnered with Boehringer Ingelheim to enhance patient treatment results in geographic atrophy (GA), an age-related progressive form of macular d


BD presents advanced ultrasound technology to help drive first-stick success for IV insertions

BD (Becton, Dickinson and Company) has launched the BD Prevue II System, an advanced ultrasound device with a specialized probe designed for optimal IV placement. The s


Inspira Technologies creates Vortx Blood Oxygenator, a remarkable technology for saturating blood with oxygen and removing carbon dioxide

Inspira Technologies OXY B.H.N. Ltd. has unveiled the Vortx Blood Oxygenator, a revolutionary device in acute respiratory care. This Augmented Respiration Technology im


MIT researchers develop a wearable patch to deliver drugs painlessly through the skin

MIT researchers have created a wearable patch that could make it easier to deliver drugs through the skin. By applying painless ultrasonic waves to the skin, the patch


Abbott's life support system acquires new US FDA approvals to help doctors treat more critically ill patients

Abbott has obtained two new clearances from the US Food and Drug Administration (FDA) for its life support system. The CentriMag Blood Pump, previously cleared for shor


US FDA awards breakthrough device designation to Reach Neuro’s Avantis platform in a boon to chronic stroke patients

Reach Neuro has acquired a Breakthrough Device designation from the FDA for its Avantis platform. It delivers small electrical impulses to the spinal cord to restore mo


US FDA grants 510(k) approval to GE HealthCare's CARESCAPE Canvas patient monitoring platform

GE HealthCare's CARESCAPE Canvas patient monitoring platform has been granted US FDA 510(k) clearance, offering flexible patient care through scalable monitoring capabi


US FDA grants 510(k) approval to Icentia’s ambulatory, continuous ECG monitoring solution, CardioSTAT

Icentia Inc. has received FDA 510(k) clearance for CardioSTAT, its ambulatory ECG monitoring solution. CardioSTAT, which relies on a wire-free, single-use recorder, has


Newly patented bone marrow biopsy device to strengthen bone cancer treatment landscape in India, says GlobalData

A new biopsy device developed by GCRI and IITRAM simplifies the tissue extraction process. The bone marrow biopsy device helps doctors identify the bone, confirms the d


Pixium's AMD Implant Wins Breakthrough Device Designation

Pixium Vision, a Paris-based company, has received a breakthrough device designation for its Prima System, an implant designed to restore vision in patients with dry ag


India's first indigenously developed surgical robot undertakes its first heart surgery in India

India's indigenous robotic system, the SSI MANTRA, created history by performing its first heart surgery. Developed by a robotic cardiac surgeon, the technology aims to


SCHOTT smart manufacturing technology perfeXion ensures 100% traceability of pharma glass tubing

SCHOTT Glass India's perfeXion smart manufacturing technology ensures 100% traceability of pharma glass tubing from furnace to final packaging, providing quality assura


Tianlong launches GeneFlex Nucleic Acid Extractor and Gentier mini+ Real-time PCR System

Tianlong has launched two new products, Gentier mini+ Real-time PCR System and the GeneFlex Nucleic Acid Extractor designed for nucleic acid extraction and real-time PC


Ad Astra Diagnostics presents 510(k) application to US FDA for QScout haematology analyzer

Ad Astra Diagnostics (AAD) has declared the submission of a 510(k) application to the US FDA for its QScout RLD rapid-result haematology system. The system can notify w


Scivita Medical collaborates with Boston Sci to Broaden Single-use Videoscope Demand

Scivita Medical Technology has entered into a strategic agreement with Boston Scientific to commercialise its single-use percutaneous choledochoscope. The two companies


Molbio Diagnostics includes TruenatH3N2/H1N1 test in its respiratory disease portfolio

India's first medical technology unicorn, Molbio Diagnostics, has launched the Truenat H3N2/H1N1 diagnostic test, approved by the Central Drugs Standard Control Organiz


TATAA Biocenter becomes an authorized Qualified Service Provider for HTG Molecular Diagnostics

TATAA Biocenter has received certification as a Qualified Service Provider for HTG Molecular Diagnostics, expanding its portfolio of molecular analysis services. This c


eTrueNorth partners with Hy-Vee to offer pharmacy-based Covid-19 and flu tests

Hy-Vee, Inc. and eTrueNorth have partnered to provide no-cost testing and treatment for Covid-19 and flu infections to Iowans displaying symptoms at nine Hy-Vee pharmac


Waters offers a sensitive and compact clinical IVD system with a Xevo TQ Absolute IVD mass spectrometer

Waters Corporation launched its latest Xevo TQ Absolute IVD mass spectrometer, expanding its range of MassTrak IVD LC-MS/MS systems used in clinical diagnostic applicat


Vijaya Medical and Educational Trust choose Dozee's AI-based contactless vitals monitoring technology

Dozee, an AI-based contactless Remote Patient Monitoring (RPM) & Early Warning System (EWS), has been implemented by Vijaya Hospital in Chennai. The solution improv


HIV self-testing to start in India: Findings from the STAR Initiative

The WHO recommends HIV self-testing (HIVST) to close gaps in HIV diagnoses among key populations like sex workers, men who have sex with same-sex, transgender individua


Amicare Hospital launches the first robotic knee replacement system in Western UP to aid in complex knee surgeries

Amicare, a well-known orthopedic and multispeciality hospital in Ghaziabad, has introduced a fully automated robotic knee replacement surgery system in western UP. This


Biovica enters a collaboration with IT Health Fusion to commercialize the DiviTum TKa assay in Italy

Biovica is a biotech company established in Sweden in 2009 with a mission to enhance the monitoring and prediction of the effectiveness of cancer therapies. Recently, t


Medtech offers user-friendly, safe, quality vaporizers to combat H3N2 with steam inhalation

As cases of H3N2 continue to rise, steam inhalation is one of the most effective ways to relieve cold and chest congestion. Medtech Life, India's largest homecare elect


Medical diagnosis with AI brings in time-bound precision for quick decisions to treatment access

AI is transforming the medical field by enhancing the accuracy of diagnoses and offering new treatments, according to Dr Ajay Hegde and Dr Girish Menon from Kasturba Me


Pristyn Care presents robotic knee replacement in Pune

Pristyn Care, India's leading secondary care provider, has introduced fully automated robotic-assisted total knee replacement surgery in Pune. The Deccan Hardikar Hospi


Illumina presents new software to allow tertiary analysis for oncology applications, and soon rare disease

Illumina Inc. recently launched Connected Insights, a new cloud-based software intended for tertiary analysis of clinical next-generation sequencing (NGS) data. It comp


Medtronic partners with to grow stroke management in India.

India Medtronic Private Limited, a subsidiary of Medtronic plc, has partnered with to integrate advanced artificial intelligence (AI) for stroke management in I


Fujifilm India unveils CAD EYE function for upper gastrointestinal diagnosis at the GI Update 2023 Mysuru

Fujifilm India, a healthcare imaging and information systems pioneer, unveiled an upgraded version of CAD EYE, a diagnostic aid for the stomach and oesophagus, at the n


US FDA endorses Emergent BioSolutions’ OTC naloxone nasal spray

The FDA has granted over-the-counter (OTC) approval for Narcan, a 4mg naloxone hydrochloride nasal spray. It is the first naloxone product to be approved for use withou


CE mark of the Getinge heart pump suspended by a second notified body, discontinuing sales for three months

TÜV SÜD has suspended the CE certificate for Getinge's Cardiosave intra-aortic balloon pump for up to three months due to concerns about risk management, post


FDA Clearance for Chitosan-Based Hemostat to Control Severe Surgical Bleeding

Axio Biosolutions, a Bangalore-based company, has developed a chitosan-based hemostat named Ax-Surgi Surgical Hemostat, which has received 510(k) clearance from the US


Fujirebio presents fully automated Lumipulse G NfL CSF and Lumipulse G NfL Blood tests

H U Group Holdings Inc. and its subsidiary Fujirebio have introduced the Lumipulse G NfL CSF and Lumipulse G NfL Blood assays for the automated Lumipulse G immunoassay


Getinge gets US FDA premarket clearance for the iCast, covered stent system

Getinge, a company that provides innovative solutions worldwide, recently announced that its iCast, the covered stent system received premarket approval by the US Food


STIM Oral Care launches STIM Sonic Electric Toothbrush to boost its portfolio

STIM Oral Care launched the STIM Sonic Electric Toothbrush, which promises superior cleaning performance and a comfortable brushing experience.


AntennaWare acquires patent for wireless tech designed to unlock implant applications

A new technology has recently been patented that has the potential to improve the wireless transmission of data from within the human body by reducing the amount of ene


The University of Cincinnati researchers conceive innovative breathing aid, PEP Buddy

Pulmonologists from the University of Cincinnati have developed a new device that could improve the lives of people with chronic obstructive pulmonary disease (COPD). T


Gestalt collaborates with Pramana to offer customers advanced, AI-enabled image analysis in an end-to-end solution

Gestalt Diagnostics Inc. and Pramana, Inc. have joined forces to provide an AI-powered digital pathology platform for laboratories and medical centres. The partnership


Agilent reveals end-to-end digital pathology workflow solution at USCAP 2023

Agilent Technologies Inc, an international leader in the life sciences, diagnostics, and applied chemical markets, has announced an end-to-end digital pathology solutio


Apollo Hospitals expands robotics to 20+specialities

Apollo Hospitals has been a trailblazer in healthcare robotics, performing over 10,000 robotics-assisted surgeries. In just two years, the number of robotic-assisted pr


Mylab Discovery Solutions partners with DnaNudge, UK, for point-of-decision diagnostic solutions.

Mylab Discovery Solutions, a biotech company based in India, has partnered with DnaNudge, a UK-based genetics testing and medical diagnostics company, to develop next-g


Medtech Life presents an ad campaign to create awareness about precise blood pressure monitoring

To address the growing number of heart attack cases in the country, Medtech Life, India's largest manufacturer of homecare electromedical devices, has launched an ad ca


BioReference presents US FDA-authorized dual-stain triage test, CINtec PLUS Cytology, to improve cervical cancer screenings

BioReference Health LLC reportedly became the first commercial laboratory to employ the CINtec PLUS Cytology test from Roche Diagnostics.


SeqOne Genomics and French CNR-MAT pioneered Oxford Nanopore sequencing technology to enhance patient outcomes in kidney disease while lowering turnaround times

SeqOne declared the outcomes of a long-standing research partnership with the French National Centre for Thrombotic MicroAngiopathies (CNR-MAT), aimed at enhancing the


MGI unveils ultra-high throughput sequencer DNBSEQ-T20×2 at MEDLAB Middle East

MGI Tech Co., Ltd., an international life science tools market leader, presented its new revolutionary product DNBSEQ-T20×2 in the Middle East region at MEDLAB Mi


US FDA grants EUA to Anavasi Diagnostics’ AscencioDx Covid-19 Test & AscencioDx Molecular Detector

Anavasi Diagnostics reported obtaining the Food and Drug Administration EUA 


Global Hospital unveils Da Vinci Xi Robotic Surgical System

Global Hospital presented the Da Vinci Xi Robotic Surgical System, designed to help surgeons perform minimally invasive surgeries accurately and safely. This state-of-t


Quantiphi and Cerevel collaborate to harness the Google Cloud’s AI capacity in clinical workflow management

Quantiphi, an AI-first digital engineering company, reportedly collaborated with Cerevel Therapeutics to harness the capacity of Google Cloud’s artificial intelli


SPR Therapeutics acquires US FDA approval for expanded labelling to grow the intended patient population for SPRINT PNS System

SPR Therapeutics, LLC, a medical device business, has received the US Food and Drug Administration (FDA) approval for expanded labelling, which boosts the intended pati


Cepheid XpertMpox test for use in a POC setting receives EUA from US FDA

The US Food and Drug Administration (FDA) awarded an emergency use authorization (EUA) for the Cepheid XpertMpox test for use in a POC (point-of-care) setting.


Medtronic’s Extravascular Defibrillator System to treat abnormal heart rhythms acquires CE marking

Medtronic plc has acquired CE-Mark for the Aurora EV-ICD MRI SureScan (Extravascular Implantable Cardioverter-Defibrillator) and Epsila EV MRI SureScan defibrillation l


US FDA grants 510(k) marketing approval to Zephyrus Innovations' Aeroject 3ml safety syringe

Zephyrus Innovations (Zephyrus) reported receiving its first product 510(k) Marketing Approval from the US FDA (Food and Drug Administration) for its Aeroject 3ml safet


Zydus Hospitals collaborates with Medtronic to present India's first indigenous AI-based stroke care network in Gujarat

Zydus Hospitals, Ahmedabad, entered a partnership with India Medtronic Private Limited, Medtronic plc's wholly-owned subsidiary, to help stroke patients in Gujarat thro


Tecan and Element Biosciences collaborate to provide benchtop NGS workflow with MagicPrep NGS & AVITI System

Tecan and Element Biosciences, Inc, the developer of an innovative DNA sequencing


US FDA approves Imaging Analysis’ new AI-based vendor-neutral software solution, LVivo IQS

DiA Imaging Analysis reported receiving the US FDA


BD presents BD Rhapsody HT Xpress System, a high-throughput single-cell multiomics platform

BD (Becton, Dickinson and Company) reported a new instrument for single-cell multiomics examination that will allow scientists to run high-throughput studies without sa


ASG Superconductors enter an alliance with Siemens Healthineers for 10.5T ultra-high field MRI systems for brain research

ASG Superconductors, a market-leading superconductor company, signed a partnership agreement with Siemens Healthineers to synergistically develop UHF MRI systems of unp


Advanced Instruments unveils Solentim Cell Metric X with automated evidence of clonality at day 0

Advanced Instruments, a scientific and analytical instruments' global supplier, reportedly launched Cell Metric X, a high-contrast imager that delivers automatic same-d


Control Print enters collaboration with V Shapes

Control Print Limited, India's leader in the manufacturing of coding and marking solutions, entered a joint ve


US FDA awards Emergency Use Authorization (EUA) to BD’s Covid-19, influenza A/B, and RSV hybrid test

BD (Becton, Dickinson and Company) reportedly received Emergency Use Authorization(EUA) from the US FDA (Food and Drug Administration) for a new molecular diagnostic co


Roche presents a Covid-19 PCR test to detect the infectious XBB.1.5 Omicron sub-variant

Roche and its subsidiary TIB Molbiol have created a Covid-19 PCR test for investigators that detects and differentiates the latest concerning variant, XBB.1.5. The XBB.1.5 variant, prevailing in th


Mylab introduces conventional kits and devices to promote decentralized diagnostics through smaller labs

Mylab Discovery Solutions is set to introduce new in vitro diagnostic medical devices and kits to promote small labs pan- India. These devices and reagents are speciall


Axion BioSystems introduces a new high-throughput live-cell imaging platform, Omni Pro 12

Axion BioSystems declares the Omni Pro 12 addition to the Omni live-cell imaging product range. The new platform features integrated robotics and a multi-plate design c


Sensorion, EVEON collaborate to design an injection system for the gene therapy delivery into the inner ear

Sensorion and EVEON announced that they have collaborated to design and develop an injection system to deliver Sensorion’s gene therapy products to the inner ear,


Getinge heart pump receives third Class I recall following the patient's death

Getinge intra-aortic balloon pumps (IABP) recall has been marked as a Class I event by the FDA (Food and Drug Administration).



Researchers developed a remote-controlled biological robot that could ultimately be used in surgery

Researchers have integrated mouse muscle tissue and a 3D-printed scaffold with microelectronics to construct small remote-controlled robots.


2San launches dual test kit for Influenza A+B & COVID-19

Healthcare products and solutions company, 2San, has launched a dual kit for Influenza A+B & SARS-CoV-2. With the continuous demand set upon the NHS post-pandemic,


Fujifilm India grows its endoscopy solutions portfolio with a new compact ultrasonic probe system at BRONCHUS 2023

Fujifilm India has expanded its endoscopy solutions portfolio with the latest compact ultrasonic probe system PB2020-M2 during the 3rd Annual conference on Intervention


Geneoscopy aspires for US FDA Premarket clearance for noninvasive colorectal cancer RNA biomarker screening test

Geneoscopy, Inc., a life sciences organisation focused on the growth of diagnostic tests for gastrointestinal health, reported submitting a Premarket Approval (PMA) app


iSono Health and Abdul Latif Jameel Health bring the world’s foremost AI-driven portable 3D breast ultrasound

Abdul Latif Jameel Health entered a new distribution contract with iSono Health, a San Francisco-based medical technology enterprise, intending to transform breast care


Hamamatsu Photonics unveils new slide scanner system

Hamamatsu Photonics, a market leader in imaging technology, presented the new NanoZoomer S20MD Slide scanner system (C16300-21MDEU).


Medtronic requests HVAD users to return batteries with welding defects

After identifying welding defects with some of the batteries employed in its HeartWare HVAD pumps last year, Medtronic has requested that patients and physicians return


US patent for IceCure Medical's Cryogen Pump for new-generation cryoablation systems

IceCure Medical Ltd., a developer of minimally-invasive cryoablation technology, the ProSense System that eliminates tumours by freezing, reported receiving the US Pate


Bayer's iodine-based contrast agent, Ultravist, receives EU approval for contrast-enhanced mammography

Bayer reported EU approval for its iodine-based contrast agent Ultravist-300, -370 for contrast-enhanced mammography (CEM). The product can be used to study and detect


Olympus received two FDA warning letters over the safety of reprocessed endoscopes

Tokyo-based Olympus Medical got two warning letters from the FDA (Food and Drug Administration) over safety issues related to reprocessing endoscopes, which involves cl


FDA asks for additional data on Abbott's rival to Medtronic balloon, setting back approval timeline

The Food and Drug Administration (FDA) has demanded further data on Abbott and Surmodics' drug-coated balloon, pushing back the companies' plans to market the device.


Loophole enables FDA authorization of unsafe medical devices, study finds

A new Yale-led study reveals that manufacturers, through an ambiguity in the law, can use an unreliable medical device as a basis for U.S. FDA (Food and Drug Administra


Biobeat reveals the prediction capabilities of its medical devices in heart failure patients

Biobeat, a worldwide leader in wearable remote patient monitoring (RPM) solutions for the healthcare continuum, reported the publication of clinical data indicating the useability of its remote pat


BD presents an automated robotic track system, BD Kiestra, for microbiology labs

BD (Becton, Dickinson and Company) launched a new robotic track system for the BD Kiestra microbiology laboratory solution that automates lab sample processing, which m


ALiA BioTech's instantaneous diagnostic platform brings multiplex testing in a single biochip in less than 15 minutes

ALiA BioTech's rapid diagnostic platform provides up to 30 results from one drop of body fluids like serum, blood, swab or urine.



Seno Medical Inks and Genetik enter partnership to distribute OA/US breast imaging system

Seno Medical and Genetik Inc. entered into an exclusive distributor contract to market, sell and service the former's innovative ImagioOpto-Acoustic/ Ultrasound (OA/US)


AI mental health chatbot tool acquires Class IIa UKCA mark

Limbic Access, a psychological evaluation AI chatbot tool that can foresee mental health disorders with 93% accuracy, received Class IIa UKCA medical device approval.


DiaCarta's monkeypox test kit gets FDA's emergency use approval

DiaCarta, Ltd (DiaCarta) has reported receiving the US Food and Drug Administration (FDA) Emergency Use Authorization (EUA) for its QuantiVirusTM MPXV test. 


Movano unveils women's health smart ring, Evie

Movano Health unveiled its smart ring, Evie, developed especially for women. Evie provides users with medical-grade health information that's translated into personaliz


Saliva test delivers faster adrenal insufficiency diagnosis

Researchers from Sheffield Teaching Hospitals have discovered that an at-home test using saliva rather than blood provides a quicker and more convenient way to diagnose


Hydro Physio to come up with a new hydrotherapy system at Arab Health

Hydro Physio, an aquatic therapy treadmill manufacturer based in the UK – will join the ABHI UK Pavilion at Arab Health 2023 to unveil its new hydrotherapy system


Aseptika achieves Innovate Smart Award for Smart Inhaler Tracker

Aseptika received an Innovate UK Smart Award for developing a Smart Inhaler Tracker for patients with lung health ailments.

The Sma


Oceanit's ASSURE-100 Rapid Covid-19 Home Test receives US FDA's Emergency Use Authorization

Oceanit reported receiving the US Food and Drug Administration (FDA) Emergency Use Authorization (EUA) for over-the-counter (OTC) use for ASSURE-100 Rapid Covid-19 Home


EOFlow seeks US FDA clearance for a wearable insulin pump, EOPatch

EOFlow Co., Ltd. reported submitting a 510(k) application to the US FDA for its wearable disposable insulin pump EOPatch. EOFlow intends to enter the US, the world&rsqu


Johnson & Johnson Vision unveils intraocular lenses for patients with astigmatism in India

Johnson & Johnson Vision reported making TECNIS Synergy Toric II OptiBlue PC-IOL (intraocular lens) available for astigmatism patients in India.


US FDA approves SI-BONE's iFuse Bedrock Granite implant system for expanded rod compatibility

SI-BONE, Inc. reported an additional FDA approval for iFuse Bedrock Granite. Newly approved indications include its use with various commercially available pedicle scre


Artificial intelligence revolutionising NHS stroke care

The British government's investment in avant-garde artificial intelligence (AI) to diagnose and decide the best treatment for stroke patients proved to be a boon for te


Biocomposites' STIMULAN obtains approval in Mexico

Biocomposites reported receiving a new broad-based approval for STIMULAN as an antibiotic carrier for use in bone and soft tissue in Mexico.  


Ada Health acquires Class II certification under MDR

Digital health company Ada Health reported its Ada Assess successfully acquired a Class IIa certification as a medical device under the European Union Medical Device Re


Click acquires FDA breakthrough designation for prescription digital migraine therapy

Click Therapeutics reported receiving breakthrough device designation for its prescription digital migraine therapy.

The Food and D


Qiagen's therascreen KRAS kit gets US FDA approval for use as a companion to Mirati Therapeutics' Krazati diagnostic test in NSCLC

Qiagen reported the USFDA (Food and Drug Administration) clearance of its therascreen KRAS RGQ PCR kit (therascreen KRAS kit) as an auxiliary diagnostic test to Mirati


Abbott unveils the smallest implantable, rechargeable spinal cord stimulation system for chronic pain, Eterna

Abbott reported the US Food and Drug Administration (FDA) clearance for its Eterna spinal cord stimulation system. Eterna SCS is the smallest implantable, rechargeable


GenWorks Health re-envisions gynaecology with Eva colposcope for the non-invasive device for cervical examination

GenWorks has recently unveiled a non-invasive device for cervical examination, Eva colposcope (Eva colpo). 

The company is pro


IHF to unveil an innovative sputum collection device, Blow-Pop, for testing TB in children

India Health Fund (IHF), an initiative funded by the Tata Trusts, shall launch a first-of-its-kind sputum collection device for testing tuberculosis (TB) among children


Virax Biolabs’ Covid-19 rapid antigen test acquires US FDA emergency use authorization

Virax Biolabs Group Limited announced that their supplier had received US FDA Emergency Use Authorization (EUA) for their over-the-counter (OTC) Covid-19 Rapid Antigen


US FDA grants 510(k) approval to IRRAS' next-generation IRRAflow control unit

The commercial-stage medical technology company, IRRAS, reported acquiring regulatory United States Food, Drug, and Administration (FDA) clearance to activate all the f


beatXP unveils Exact smartwatch redefining the accuracy of wearable devices

beatXP, a fit-tech D2C brand by Pristyn Care, unveiled quite a unique smartwatch, Exact, that aims to redefine precision care with a cut above the rest. The Exact smart


Dexcom Ends the Year on a High with FDA approval for G7

One of the most awaited devices in Medtech has finally received FDA clearance. Dexcom received approval for the G7 Continuous Glucose Monitor after a few delays.



Masimo’s pulse oximeter has no noteworthy racial bias: Study

According to retrospective analysis, Masimo’s pulse oximeter data has found no substantial differences in the outcomes between Black and White people.


Abbott launches the TAVI system, Navitor, for the treatment of aortic stenosis in India

Global healthcare company Abbott launched Navitor, its latest-generation transcatheter aortic valve implantation (TAVI) system, making the minimally invasive device ava


BIOCORP's Mallya gets 510(K) approval from US FDA

BIOCORP reported acquiring US Food & Drug Administration (FDA) 510(K) clearance from the to-market Mallya.

BIOCORP is a French


Activ Surgical acquires CE Mark for Enhanced Imaging System Image courtesy of Business Wire

Activ Surgical reported acquiring CE Mark authorization for its ActivSight Intelligent Light. 

The CE Mark validates that Acti


Vyrsa Technologies presents VYRSA V1 SI Fusion System

Vyrsa Technologies reported the FDA authorisation for the VYRSA V1 SI Fusion System. After a comprehensive 30 months biomechanical testing protocol, Vyrsa Technologies


Medtronic claims the benefits of the latest Evolut TAVR system in retrospective analysis

As per the retrospective analysis, Medtronic’s Evolut FX has been linked to better commissure alignment in transcatheter aortic valve replacement (TAVR) procedure


GE Healthcare partners with MediView XR to launch an augmented reality (AR) X-ray imaging system

GE Healthcare has collaborated with MediView XR to devise a technology that equips a heads-up, augmented reality (AR) display of interventional x-ray imaging systems.

The product, OmnifyXR,


Medtronic’s HVAD system recalled again as a new driveline cover problem surfaces

Medtronic issued a new recall notice for its HeartWare HVAD heart pump due to fresh issues with its driveline cover that shields the connection between the pump and the


GenWorks launches numerous high-tech machines and medical devices to secure newborn care

Intending to manage hypothermia in infants in India, GenWorks has developed a string of high-tech gadgets for newborn care - Lullaby Resus Prime, Lullaby Warmer, Brainz


FDA categorises Baxter's hospital bed system recall as the most serious

The Us FDA has classified the recall of Baxter International Inc's hospital bed systems as the most serious type, on apprehensions that it could lead to life-threatenin


Fujifilm Europe to market and sell Scivita Medical's single-use bronchovideoscopes in major European countries

Netherlands-based Fujifilm Europe B.V. ('Fujifilm')and Scivita Medical Technology Co., Ltd. ('Scivita Medical') entered strategic marketing and sales agreement.


Philips identifies new issues with previously replaced ventilators

According to an FDA statement, Philips, already struggling with a major recall of ventilators, identified additional problems with some previously replaced machines.


A. Menarini Diagnostics to market and sell QuantuMDx's Q-POC platform in UK & France

The UK-based developer of transformational Point-of-Need molecular diagnostics, QuantuMDx Group Limited (QuantuMDx), and A.Menarini Diagnostics S.r.I. (Menarini), decla


US FDA awards 510(k) approval for Baebies G6PD test on the FINDER platform

Baebies received US Food and Drug Administration (FDA) 510(k) approval for its rapid, point-of-care (POC) test for glucose-6-phosphate dehydrogenase (G6PD) deficiency.


Genesis MedTech's Chocolate Touch Drug-coated Balloon PTA Catheter receives US FDA approval to treat peripheral artery disease

Genesis MedTech Group's Chocolate Touch Drug-coated Balloon PTA Catheter reportedly obtained the USFDA (Food and Drug Administration) approval for treating patients wit


Virax Biolabs launches RSV-Influenza-Covid Triple Virus Antigen Rapid Test Kit in EU

Virax Biolabs (Virax) reported launching a RSV-Influenza-Covid Triple Virus Antigen Rapid Test Kit in markets abiding by the CE mark, like the European Union.


US FDA approves Neurosteer single-channel EEG brain monitoring platform

Neurosteer Inc. reported the FDA approval of its Neurosteer single-channel EEG brain monitoring platform. This approval allows Neurosteer's unobtrusive multi-purpose sy


Medtronic introduces TruClear & HysteroLux System for diagnostic, operative hysteroscopy in India

India Medtronic Private Limited (a wholly-owned subsidiary of Medtronic plc) has declared the TruClear system's launch, a mechanical hysteroscopic tissue removal system


Researchers develop a light-based sensor to overcome the diagnostic constraints of electrodes

Researchers have devised sensors employing liquid crystal and integrated optics technologies to gauge neural activity with light.

The scientists, reporting in the Journal of Neural Engineer


OraSure Technologies acquires US FDA clearance for ORAcollect•Dx saliva collection device for OTC use

OraSure Technologies, Inc., a global leader in POC (point-of-care) and home diagnostic testing and specimen collection technologies, reported receiving US FDA approval


Omnivision collaborates with AdaptivEndo on hybrid and single-use endoscopes

OmniVision and AdaptivEndo entered an alliance to create a platform for hybrid and single-use endoscopes, comprising systems used for urology, gastroenterology, hepatol


Teleflex recall of respiratory filters labelled Class I by FDA

The Wayne, Pennsylvania-based organization’s Gibeck Iso-Gard Filter S devices are bacterial filters attached to respiratory equipment or breathing systems in ICUs


Mettler-Toledo launches a new combination check weighing and serialization system for pharma and cosmetics producers

Mettler-Toledo Product Inspection introduced a new Checkweighing and Track & Trace combination solution targeted at small and mid-market manufacturers in the cosmet


The Cambridge, MA-based enterprise acquired a breakthrough device designation for its SinaptiStim

After almost ten years of research and investigation, Sinaptica Therapeutics has acquired the FDA’s Breakthrough Device Designation for its SinaptiStim – AD


OTC hearing aid maker Nuheara earns 510(k) approval for HP-branded device, undercuts Lexie, and Sony on price

Nuheara has acquired 510(k) approval for a self-fitting OTC (over-the-counter) hearing aid, enabling it to sell the HP-branded product in the market.


Biosense Webster launches radiofrequency balloon ablation catheter, HELIOSTAR, in Europe

Biosense Webster, Inc. declared the European introduction of the HELIOSTAR Balloon Ablation Catheter – the foremost radiofrequency balloon ablation catheter. The


Genrobotics launches G-Gaiter for paraplegic, gait disabilities

Genrobotics, a national award-winning start-up and a developer of the global's first robotic scavenger - Bandicoot, has introduced its latest robotic gait trainer, 'G-G


Dozee to introduce AI-based ECG patch for remote cardiac monitoring

Dozee, India's first contactless RPM (remote patient monitoring) company, will shortly venture an ambulatory ECG (electrocardiogram) patch to monitor patients with CVD


Vestige introduces Absorvit sublingual oral spray to address vitamin deficiency

Vestige Marketing Pvt. Ltd, India’s leading home-grown direct-selling company, has declared the introduction of Absorvit under the Vestige Prime brand. It is an i


IHL launches Heart Health Calculator

India Health Link (IHL) has designed a tech-driven Heart Health Calculator, which aids as a preventive tool that assists in heart risk assessment using various factors, including age, BMI, blood pr


MedMira's VYRA Covid-19 Antigen Test acquires CE mark approval

MedMira Inc. reportedly received the CE mark approval for its VYRA Covid-19 Antigen Test (VYRA Covid-19), the quickest SARS-CoV-2 Antigen test available.


Max Ventilator launches pulse oximeters, ECG, and monitors to meet their growing demand

After conquering the terrain of the ventilator market, the leading manufacturer of medical devices, Max Ventilator, is set to expand its niche by rolling out intelligen


Abdul Latif Jameel Health and Wellesta enter partnership to launch Butterfly iQ+ point-of-care ultrasound device in India

Abdul Latif Jameel Health collaborated with Wellesta Holdings Pte. Ltd, Singapore, for marketing and distributing the Butterfly iQ+ point-of-care (POC) ultrasound devic


Diaclinic to market and sell the Nanomix eLab system in the Republic of Chile

Nanomix Corporation, a pioneer in developing mobile, reasonable, point-of-care (POC) diagnostics, announced a new marketing agreement with Chile's medical distributor D


The FDA approves NovaSight’s digital treatment for lazy eyes, providing a revolutionary substitute to patching

NovaSight’s digital treatment for amblyopia, also known as lazy eye, received approval for use in the U.S. by the FDA (Food & Drug Administration).


Provista Diagnostics aims EUA approval from US FDA for PCR MonkeyPox Test

Todos Medical, Ltd., a complete medical diagnostics and corresponding solutions business, announced filing a EUA (Emergency Use Authorization) application with the USFD


PocDoc confirms UKCA mark for digital cholesterol test

PocDoc, the personal diagnostics provider and digital health platform, has secured the UKCA mark for its smartphone-based test for cholesterol. 


Abbott’s FreeStyleLibre 2 CGM wins over fingerstick testing in an autonomous clinical trial

A randomized controlled trial has correlated Abbott’s FreeStyleLibre 2 continuous glucose monitor (CGM) to significantly reduce blood sugar levels than fingerstic


Do-it-yourself artificial pancreas system exceeds production-line pump in a controlled trial

The capability to customize open-source, “do-it-yourself” automated insulin delivery (AID) systems may make them more practical at controlling blood glucose


SyntheticMR’s SyMRI MSK software for spine and knee imaging acquires Brazilian regulatory clearance

SyntheticMR reportedly got regulatory approval in Brazil for their quantitative imaging software solution for knee and spine imaging, SyMRI MSK, and can now sell and di


FDA labels open-heart-surgery blood pump, recalled by LivaNova, as Class I

LivaNova’s recall of 484 LifeSPARC circulatory support systems from the U.S. has been designated as a Class I event by the Food and Drug Administration (FDA).


Healthium Medtech acquires CE certification under the EU MDR standards for class III implants

Healthium Medtech reported that the company acquired the new CE certification under the strict European Union Medical Device Regulation (EU MDR). As a part of the rule


Dexcom initiates the global rollout of the G7 CGM system, with the device launch in U.K. and Germany

Dexcom initiated the global rollout of its G7 continuous glucose monitoring system by making the device available in Austria, U.K., Germany, Ireland, and Hong Kong.


BD informs cybersecurity risk in the cervical cytology processing device

Becton Dickinson has informed a cybersecurity susceptibility that could authorize attackers to access and alter information on an apparatus used to process cervical cytology samples.

The vu


Veterans Affairs partners with FDA to accelerate medical device development

The Food and Drug Administration (FDA) collaborated with the Department of Veterans Affairs healthcare wing to help accelerate American medical device innovation.


BrightInsight enters collaboration with bioMérieux to launch Clinical Digital Solutions for Diagnostics

BrightInsight, Inc., and bioMérieux declared today a partnership to devise and bring to market a Clinical Digital Solution for diagnostics allowing clinical deci


TestCard and Roche enter a testing alliance on cobas pulse

British MedTech firm TestCard entered a partnership contract with Roche to include its scanning technology, ClearScreen, in the open digital ecosystem used by the healt


Tive declares a validated, comprehensive cold chain solution for pharma & biological industries

Tive reported a portfolio of real-time cold chain logistics solutions for pharmaceutical, biological, and cell gene therapy companies. Tive’s multi-sensor Solo 5G


KIMS Hospitals presents a fully automated robotic surgery procedure

KIMS Hospitals Kondapur has consistently been at the forefront of patronizing the latest technological specialized inventions that could help accomplish more promising


Mylab Discovery Solutions introduces PathoDetect HPV Detection Test to detect high-risk HPV types

Mylab Discovery Solutions launched the ‘PathoDetect HPV Detection Test,’ a real-time PCR-based screening solution to catch HPV high risk in people.


TO THE NEW introduces mental wellness and meditation app, Idanim for corporate professionals

TO THE NEW has launched Idanim, a meditation, and mental wellness app. TO THE NEW are a digital tech services company and a seven-time winner of a great place to work,<


Biocorp, Sanofi announce the completion of the development of SoloSmart, an accessory medical device for SoloStar injection pens

Biocorp and Sanofi announced the completion of the development of SoloSmart, at the inaguration of the European Association for the Study of Diabetes (EASD) annual meet


KareXpert deploys cloud-based solutions in 145+ facilities

Companies like KareXpert have come into the limelight to address healthcare challenges by digitally transforming our country's hospitals. In 1 year, the Jio-backed SaaS


Recall of 17M sleep apnea masks over magnets that could concern implanted devices: Philips

Philips recalled more than 17 million masks utilized with its respiratory devices over concerns that magnets in the masks could impact some patients with implanted medical devices. The FDA (Food an


FDA warns physicians to lock malfunction with Abbott’s MitraClip heart valve device

The FDA (Food and Drug Administration) has cautioned healthcare providers about potential malfunctions with the Abbott Laboratories’ MitraClip heart valve device


FDA approves Magnus neuromodulation system for major depressive disorder

The U.S. Food and Drug Administration granted 510(k) clearance to Magnus Medical’s SAINT Neuromodulation System for treating major depressive disorder (MDD). 


Abbott heart device for infants exhibits longer-term usefulness with three-year data

Abbott reported updated data on its treatment for premature infants with a heart defect, demonstrating that 95.5% of patients were alive after three years.


Wipro GE Healthcare unveils ‘Made in India’ AI-enabled Cath lab

GE Healthcare unveiled its ‘Made in India’, ‘AI-powered’ Cath lab-Optima IGS 320 to promote cardiac care in India.


Ibex collaborates with Medipath to foray into artificial intelligence for cancer diagnosis across France

Ibex Medical Analytics and Medipath announced a partnership to grow the deployment of artificial intelligence (AI) to more labs in the Medipath network. The deployment includes new AI-powered apps


Indica Labs partners with iCAIRD to devise an AI-based algorithm to report lymph node status in colon cancer automatically

Indica Labs and The Industrial Centre for Artificial Intelligence Research in Digital Diagnostics (iCAIRD) reportedly collaborated to develop an AI-based digital pathol


IceCure Medical aspires to Vietnam's permission for the ProSense system

IceCure Medical Ltd., the developer of minimally-invasive cryoablation technology, reported submitting a regulatory filing with the Department of Medical Equipment and


SkylineDx presents Merlin Assay as a CE-IVD kit in Europe

SkylineDx reports the commercial launch of Merlin Assay as a CE-IVD marketable test kit in Europe.

Merlin Assay identifies melanoma


US FDA approves eCential Robotics’ surgical robotic platform for spine surgery

eCential Robotics, a French MedTech company, reported FDA 510(k) clearance of its 3D imaging, navigation, and robotics guidance system, ensuring the marketing of its unified robotic platform in the


Hikma presents Ryaltris seasonal allergic rhinitis nasal spray in the US market

Hikma Pharmaceuticals PLC (Hikma, Group), and Glenmark Specialty S.A. declared the launch of Ryaltris (olopatadine hydrochloride and mometasone furoate nasal spray) in


MGM Healthcare's Balloon Eustachian tuboplasty surgery technique acquires global accreditation

MGM Healthcare reported that its novel surgical technique of non-invasive Balloon Eustachian Tuboplasty (BET) of the Institute of ENT, head & neck surgery has been


Roche launches digital PCR system, Digital LightCycler System

Roche unveiled Digital LightCycler System, its first digital polymerase chain reaction (PCR) system. This next-generation technique detects disease and is designed to p


Medtronic unveils SenSight directional lead system in India for deep brain stimulation therapy

India Medtronic Private Limited launched the SenSight directional lead system for deep brain stimulation (DBS) therapy to treat the symptoms associated with movement di


US FDA approves Abbott's latest Proclaim Plus spinal cord stimulation device

Abbott declared receipt of the US Food and Drug Administration approval for its new Proclaim Plus spinal cord stimulation (SCS) system featuring FlexBurst360 therapy. T


SmartCardia unveils a one-of-its-kind 7-lead cardiac monitoring patch to furnish insights into patients’ fitness

SmartCardia presented the 7L patch, their 7-lead cardiac monitoring patch in India. This cutting-edge patch monitor combines medical wearable technology with AI to deli


Dozee and Midmark unveil India’s foremost intelligent connected bed to drive remote patient monitoring

Dozee and Midmark India, South Asia's biggest manufacturer of hospital beds and allied furniture, having a great presence in India, have come together to form India's f


KIMS Hospitals unveils Quicktome, brain mapping technology

KIMS Hospitals declared the launch of brain mapping technology - Omniscient Neuro-technology’s Quicktome to additionally strengthen their infrastructural faciliti


Visibly aquires FDA approval for self-administered online vision test

Visibly has obtained FDA's 510(k) approval for an on-demand, self-administered visual acuity test that allows consumers to scan their vision online.


Eargo intends to sell its hearing aids in stores after the over-the-counter order

Eargo, a hearing aids manufacturer, intends to start selling its devices in retail stores in 2022 as the Food and Drug Administration approved the over-the-counter (OTC


Edwards obtains a CE mark for the Pascal Precision system, authorizing the device to be sold in Europe

Edwards Lifesciences acquired a CE mark for its Pascal Precision system, its latest treatment for patients with mitral and tricuspid regurgitation.


FDA Endorses Over-the-Counter Hearing Aids

To lower the costs of hearing aids and make the devices easily available, the Food and Drug Administration (FDA) issued a rule to allow adults with mild to moderate hea


Medtronic gets the third Class I label in 2022 for the latest HVAD recall

Medtronic is recalling nearly 40,000 batteries for its HeartWare Ventricular Assist Device (HVAD) system for performance issues.



FDA reapproves Meridian’s COVID-19 test after modifications to facilitate omicron detection

The Food and Drug Administration (FDA) reapproved Meridian Bioscience’s Revogene SARS-CoV-2 molecular assay for emergency use (EUA).


CardiAI presents its latest ambulatory blood pressure monitoring device

Biotechnology company CardiAI announced the worldwide introduction and marketing of BPAro, its latest 24-hour Ambulatory Blood Pressure Monitoring (ABPM) system.



North American Diagnostics recall of COVID-19 tests labeled Class I by FDA

North American Diagnostics is recalling over 122,000 oral rapid COVID-19 antigen test kits as they were marketed without US Food and Drug Administration authorization,


Medtronic unveils an AI-powered GI Genius module for colonoscopy in India

Medtronic India came up with an ingenious computer-aided polyps detection technique powered by artificial intelligence (AI), the GI Genius intelligent endoscopy module.


Medtronic initiates Class I recall of implantable cardioverter defibrillators in the U.S.

Medtronic initiated recalling its Cobalt and Crome implantable cardioverter defibrillators from the U.S. for potential of reduced shock energy. The Class I recall encom


Checkpoint Surgical presents a unique nerve cutting kit

Checkpoint Surgical has extended its intraoperative nerve care portfolio as it came up with a Checkpoint Edge Nerve Cutting Kit.



BioCircuit acquires FDA approval for nerve repair device

BioCircuit Technologies, a National Institutes of Health (NIH)-funded medical gadget enterprise focused on tissue repair and neuromodulation, has acquired FDA 510(


BioGX presents a three-gene multiplex Covid-19 test

Molecular diagnostic solutions provider BioGX launched a CE-IVD marked multi-gene Covid-19 point-of-care (POC) test.

The latest thr


DIESSE and Menarini collaborate for CHORUS TRIO system marketing in the US

DIESSE Diagnostica Senese entered a commercial agreement with Menarini Silicon Biosystems, a Menarini group subsidiary, to market its CHORUS TRIO immunometric assay sys


HealthTrackRx devises a new test to detect the monkeypox virus

Diagnostic testing lab HealthTrackRx has devised a new molecular test to detect the human monkeypox virus.

The new HealthTrackRx as


Predicine acquires FDA EUA for the SARS-CoV-2 test and self-collection kit

Molecular insights firm Predicine has received USFDA's emergency use authorization (EUA) for its SARS-CoV-2 RT-PCR test and self-collection kit.


Rhinostics presents a new blood collection device

Rhinostics has come up with a new device, VERIstic, which focuses on the collection of small volume blood in both at-home and clinician-assisted collection procedures.<


Baxter brings Welch Allyn RetinaVue 100 Imager PRO in South Korea

US-based health care establishment Baxter launched its Welch Allyn RetinaVue 100 Imager PRO in South Korea.

The device is designed


GE Healthcare presents Voluson Expert 22 ultrasound

GE Healthcare introduced Voluson Expert 22, the next-generation advanced ultrasound for women’s health.

It uses graphic-based beam former technology to deliver better flexibility in i


BioCircuit acquires FDA approval for nerve repair device

BioCircuit Technologies, a National Institutes of Health (NIH)-funded medical device corporation focused on tissue repair and neuromodulation, acquired FDA 510(k) autho


Embolx aims for FDA 510(k) clearance for Soldier microcatheter

Embolx presented an application seeking 510(k) approval from the USFDA for its new high-flow microcatheter product line, known as Soldier.


Greenlight Guru acquires ISO 9001 and 27001 certification

Greenlight Guru, a developer of the MedTech Lifecycle Excellence Platform, receives International Standards Organisation certification for both ISO 9001 - Quality Manag


Novacyt exsig PCR test cleared by UKHSA

Novacyt, a clinical diagnostics expert, received authorization for its exsig COVID-19 Direct Real-Time PCR test under the (UKHSA) UK Health Security Agency's Medical De


TechMed 3D comes up with a new processing software

TechMed 3D, a human body solution measuring software supplier, has launched SNAP by TechMed. This portable automatic processing software for human body 3D acquisition a


Bruker brings NMR tests for Long COVID research

Bruker Corporation has come up with PhenoRisk PACS RuO, a research-use-only NMR test for molecular phenomics research on ‘Long COVID’ patients’ blood


Apollo Hospitals combines cardiovascular risk tools and ConnectedLife digital wellness solutions

Asia's leading integrated healthcare services provider, Apollo Hospitals, announced an exclusive partnership with ConnectedLife, leaders in the application of motor sta


BD's emergency vascular access devices recalled for risk of delayed care

Becton Dickinson is recalling its range of products employed to deliver fluids and medications during life-saving procedures and resuscitations due to issues that could


Intuitive obtains FDA approval for lung biopsy robot featuring Siemens’ imaging tech

The Food and Drug Administration (FDA) approved the integration of Siemens Healthineers’ mobile imaging into Intuitive’s robotic-assisted platform for minim


ProteoNic permits a premium 2G UNic technology platform for manufacturing of biologics to FyoniBio

ProteoNic, and FyoniBio GmbH, announced to have entered into a technology licensing contract, under which FyoniBio gains worldwide, non-exclusive commercial rights for


Abacus Diagnostica comes up with PCR tests for encephalitis and meningitis

Abacus Diagnostica, a Uniogen company, launched a new rapid PCR test in the European markets for quick identification of viruses causing viral encephalitis and meningit


IIT Madras conceives Artificial Intelligence-based tool for personalized cancer diagnosis

An Artificial Intelligence-based tool to predict cancer-causing genes in a person has been developed, paving the way for conceiving customized cancer treatment strategi


LiveMetric’s blood-pressure ‘smartwatch’ device acquires FDA approval

A smartwatch cum blood-monitoring device produced by LiveMetric secured 510(k) clearance from the FDA (Food and Drug Administration). The device is cuff-free. 


Clarius partners with ImaCor to present a handheld transesophageal echocardiography (TEE) system

Clarius Mobile Health and ImaCor Inc entered a collaboration to enable the availability of the world’s first handheld TEE (transesophageal echocardiography) syste


Yourgene Health presents LightBench Detect for fetal fraction enrichment

Yourgene Health plc launched the LightBench Detect, the newest addition to its Ranger Technology instrumentation portfolio at the 26th ISPD (International Conference on


Meridian Introduces unique qPCR master mixes for stool samples to accelerate the development of molecular assays

Meridian Bioscience Inc. announced two new sample-specific master mixes Lyo-Ready Direct RNA/DNA qPCR Stool Mix and Lyo-Ready Direct DNA qPCR Stool Mix. These ingenious


Avinger boosts its international presence with the commercial launch of Lumivascular products in Chile

Avinger, Inc., a medical device company, bettered its global presence with the commercial launch of its Lumivascular products in Chile. Avinger's new Lightbox 3 imaging


Medtronic and GE Healthcare's collaboration allows for improved monitoring

Clinicians now have added the capability to personalize care with the integration of two continuous monitoring solutions from Medtronic – Microstream capnography


FDA Breakthrough designation for sepsis treatment device

Santersus received FDA's Breakthrough Device designation for its medical device product, NucleoCapture. The FDA's Center for Devices and Radiological Health (CDRH) gran


German start-up acquires a CE mark for two new PCR tests

Spindiag, Freiburg/Breisgau, Germany, acquired CE-IVD conformity for two new tests for its Rhonda PCR rapid testing system.

The new


Innova's rapid COVID-19 self-test receives a CE mark

Innova Medical Group's "SARS-CoV-2 Antigen Rapid Qualitative Self-Test" has earned CE mark certification.

The European CE mark Conf


FX Solutions secures FDA 510k approval for the FX V135 platform

FX Solutions acquired USFDA (Food and Drug Administration) 510k approval for its new FX V135 shoulder arthroplasty platform.

The FX


Bionano and Hamilton Genomics materialize DNA extraction automation solutions

Bionano and Hamilton Genomics have developed Long String VANTAGE, a new DNA extraction automation solution.

The device can extract


Laserlinc comes up with the 'world's first' automation for off-line tubing testing

Laserlinc introduced the world's first automation for off-line testing of long and thin medical tubing products (urinary and coronary catheters), complex-shaped piece parts, braided cables, ridged


Oncologica brings the Allergyfocus test to detect common global allergies

Oncologica announced the launch of Allergyfocus, a new antibody allergy test that quickly and accurately detects 99% of typical global allergies.


USFDA approves Medicalgorithmics’ Qpatch ECG monitoring device

The USFDA (Food and Drug Administration) approved Qpatch, Medicalgorithmics’ ECG wearable unit. The FDA approval gives a green signal to the company to market Qpa


Owen Mumford's Unifine brand gets a safety pen needle

Owen Mumford's next-generation safety pen needle, Unifine SafeControl, will join the Unifine brand making its diabetes care portfolio stronger. Unifine SafeControl desi


BD comes up with a second flu/COVID-19 combination test

An automated multiplexed real-time RT-PCR test, BD SARS-CoV-2/Flu, detects and differentiates SARS-CoV-2 and influenza A, and/or influenza B from a single nasal specime


LumiraDx acquires CE mark for two Fast Lab Solutions molecular tests

LumiraDx has obtained CE mark for two Fast Lab Solutions multiplex tests, SARS-CoV-2 & Flu A/B RNA STAR Complete and Dual-Target SARS-CoV-2 STAR Complete.


A diagnostic test to differentiate between Bacterial and viral infection launched in Israel

After USFDA approved its MeMed BV test (a test that helps physicians distinguish between bacterial and viral infections in 15 minutes), Maccabi Healthcare Services is l


The FDA's Class I label for Abbott’s imaging catheter recall due to vascular injury risks

The Food and Drug Administration (FDA) graded Dragonfly OpStar Imaging Catheters recalled by Abbott Laboratories as a Class I event as the device may lead to vascular i


Intertronics comes up with new series of wearables adhesives

To help manufacturers of wearable devices adapt to industry trends and customer requirements, Intertronics has launched the Dymax 2000-MW series of medical wearables ad


Verily proffers smartwatch toward Parkinson’s clinical trial use after validating the technology

Researchers yielded proof that Verily’s wearable device can record measurements that could serve as digital biomarkers of Parkinson’s disease progression.


QuantuMDx comes up with a respiratory panel test

UK-based developer of point-of-care (POC) diagnostics, QuantuMDx, launched Q-POC SARS-CoV-2, Flu A/B & RSV Assay, a new respiratory panel test.


DRW's two multiplex virus tests achieve UK technical validation

Diagnostics for the Real World Ltd (DRW), has achieved UK technical validation for two multiplex respiratory virus tests (SARS-CoV-2/RSV and SARS-CoV-2/FluA/FluB).


Nanōmix’s Covid-19 rapid antigen test secures the CE mark

Nanōmix's Covid-19 rapid POC (point-of-care) antigen panel secured a CE mark.

The test uses an anterior nasal swab and generates r


WHO approves LumiraDx Covid-19 antigen assay for EUL (Emergency Use Listing)

The World Health Organization (WHO) gave EUL to LumiraDx's rapid antigen assay for Covid-19 detection.

The LumiraDx SARS-CoV-2 Ag T


LumiraDx's SARS-CoV-2 Ag Ultra Test attains the CE mark

LumiraDx, a Point of care diagnostics company, secured a CE mark for its SARS-CoV-2 Ag Ultra Test that can deliver results in five minutes, allowing clinicians to start


Mainz collaborates with Dante Labs to market colon cancer detection test

Mainz Biomed and Dante Labs entered a collaboration to market ColoAlert, in Italy and the United Arab Emirates (UAE).

ColoAlert is


The FDA labels Avanos Medical recall as Class I

The Food and Drug Administration (FDA) gave Class I labeling to Avanos Medical’s recall of a system to help place medical feeding tubes after dozens of reports of


CVRx receives FDA clearance for MR labeling for Barostim

The U.S. Food and Drug Administration (FDA) cleared CVRx Barostim System for magnetic resonance (MR) conditional labeling.

The Baro


Alamar partners with Mologic to develop sensitive COVID-19 tests

Alamar Biosciences is a proteomics company that helps in the early detection of cancer and other diseases, while Mologic is the developer of lateral flow and rapid diag


Adapttech and Guenther Bionics collaborate for prosthetics distribution

Biomedical scale-up Adapttech collaborated with Guenther Bionics to market prosthetic fitting solutions in Germany.

Adapttech inten


B-Secur launches HeartKey 2.0, a new EKG monitoring technology

B-Secur, a global heart health-tech firm came up with HeartKey 2.0, new cloud-based software that reduces EKG signal noise. It improves EKG interpretation to new height


FDA approves PCR test that delivers results in 27 minutes

The U.S. Food and Drug Administration (FDA) granted EUA (Emergency Use Authorisation) to MicroGEM Sal6830 SARS-CoV-2 Saliva Test. This test provides PCR (polymerase cha


The US FDA clears Hologic for Aptima CMV Quant assay

Hologic, a US-based med-tech company, got US Food and Drug Administration (FDA) approval for its Aptima CMV Quant assay.

The test w


CE Mark approval for Lucira’s Covid-19 & Flu and Covid-19 Molecular Tests

Med-tech firm Lucira Health' Covid-19 & Flu and Covid-19 molecular tests got CE mark approval for professional use.

The approva


Adaptiiv collaborates with Varian and HP to support cancer treatment.

Adaptiiv Medical Technologies partnered with Varian, a Siemens Healthineers company, and HP to support cancer therapy.

The alliance


Hemex modernizes Gazelle Hb Variant to scan hydroxyurea therapy

Hemex Health, a US-based med-tech start-up, updated its Gazelle Hb Variant test.

The latest improvement will allow more accurate measurements of fetal hemoglobin Hb F and assist in the moni


Abbott’s 4-in-1 Alinity PCR test for sexually transmitted infections gets FDA approval

Abbott acquired FDA approval for a molecular PCR assay to detect and differentiate four typical STI's (sexually transmitted infections).


Abbott, CamDiab & Ypsomed associate to design and commercialize an automated insulin delivery system for people with diabetes

Abbott, CamDiab, and Ypsomed declared that they are partnering to generate and commercialize a blended automated insulin delivery (AID) system to lessen the load of rou


Fresenius Medical Care obtains US FDA 510(k) clearance for VersiPD Cycler System

Fresenius Medical Care, the leading provider of products and services for individuals with renal diseases, declared that the US Food and Drug Administration (FDA) had g


Co-Diagnostics Indian-based JV CoSara obtains CDSCO clearance for hepatitis C viral load test

Co-Diagnostics, Inc. declared that CoSara Diagnostics Pvt Ltd (CoSara), its joint venture for manufacturing and sales in India, has acquired clearance by the CDSCO (Cen


Amcor presents additionally sustainable High Shield laminates to its pharmaceutical packaging portfolio

Amcor, a global leader in designing and delivering reliable packaging solutions, declared the addition of unique, more endurable High Shield laminates to its pharmaceut


Axonics presents Axonics F15 recharge-free sacral neuromodulation system in the US market

Axonics, Inc., a global medical technology company, declared the exhaustive launch of the Axonics F15 across the United States. In March, the newly developed, long-live


NTC aspires for European marketing approval for Kleerkol for bowel preparation for colonoscopy

NTC Srl, an R&D-driven pharmaceutical company, declares the submission of the marketing approval application via the European DCP (Decentralised Procedure) for its


Aura Air air-purifiers to India were clinically certified for their effectiveness against the SARS-CoV-2 virus after hospital studies

Aura Air air-purifiers have successfully cleared clinical trials establishing their effectiveness against the coronavirus in an analysis completed at Sheba Medical Cent


US FDA authorizes SonoScape's flagship video endoscopy system, HD-550

SonoScape declared that the US FDA (Food and Drug Administration) approved its flagship video endoscopy system HD-550 for gastrointestinal diagnosis, setting up a major


Medtronic's recall of above 175,000 MiniMed pumps: Class II recall by FDA

In January, Medtronic commenced a recall concerning over 175,000 MiniMed automated insulin pumps because of programming intricacies that could result in the under-deliv


MedGenome pitches VarMiner to detect genetic variants for rare diseases and inherited cancers

MedGenome Labs, South Asia’s foremost genomics research and diagnostics company, has developed and launched VarMiner, an AI-enabled effective variant interpretati


OMNIgene·GUT Dx microbiome collection device obtains de novo authorization from US FDA: OraSure Technologies

OraSure Technologies, Inc declared its OMNIgene·GUT Dx (OMD-200) microbiome collection device presented de novo authorization from the US FDA (Food and Drug Admi


Dr. Lal PathLabs to use drones for the transport of blood samples

Dr. Lal PathLabs, India’s leading network of national reference laboratories, clinical laboratories, patient service centers, and sample pick-up points, declared


Flipkart launches the Flipkart Health+ app.

Flipkart Health+, the digital healthcare marketplace forum of India's homegrown Flipkart Group, ventures the Flipkart Health+ app. This tech platform enables access to


NanoString introduces the new nCounter Pro Analysis System

NanoString Technologies, Inc. declared the commercial unveiling of the nCounter Pro Analysis System, the successive generation of the nCounter instrument platform. The


Ametek Brookfield presents an RSX touchscreen rheometer for controlled rate/stress measurements.

Ametek Brookfield is enthusiastic to announce the introduction of its new RSX Rheometer.

The RSX is a progressive rheometer instrum


CURIA declares its cancer app available on the Play Store in India, Australia, Austria, Spain, Italy & UAE

CURIA, designed by Innoplexus AG, has become the most decentralized cancer data ecosystem globally. The app is currently obtainable in 12 geographies and is ranked #1 i


US FDA approves Artio Medical’s Solus Gold Embolization Device

Artio Medical, Inc. declared it received US Food and Drug Administration (FDA) clearance for its Solus Gold Embolization Device, a next-generation product for periphera


MFine facilitates blood pressure & glucose monitoring on smartphones permits monitoring vitals without an additional device

Digital health platform MFine has revealed blood pressure (BP) and glucose monitoring on a smartphone. The company declared an industry-first breakthrough to add BP &am


Snowflake establishes Healthcare & Life Science Data Cloud for better patient care & business results

Snowflake, a data cloud company, has declared the Healthcare & Life Sciences Data Cloud launch to assist providers in delivering improved patient outcomes, optimizi


UK MHRA authorizes LumiraDx Covid-19 molecular assay, SARS-CoV-2 RNA STAR Complete

LumiraDx declared that its rapid Covid-19 molecular assay, LumiraDx SARS-CoV-2 RNA STAR Complete, has been successfully approved by Coronavirus Test Device Approvals (C


Carestream India establishes The DRX Compass, an evolved digital radiology solution

Carestream Health India declares the launch of DRX (digital X-ray) Compass, an accurate, configurable, and convenient digital radiology solution devised to equip radiol


PROmate Covid-19 2G RT PCR test gets clearance in the UK under CTDA legislation: Novacyt

Novacyt declared that the Company’s PROmate Covid-19 2G Real-Time PCR test is approved in the UK under the (Coronavirus Test Device Approvals) (Amendment) Regulat


Launch of a wearable device for glucose and BP's home monitoring: Amrita Vishwa Vidyapeetham with Tranquility IOT and Big Data

Amrita Vishwa Vidyapeetham has collaborated with the Kochi-based startup Tranquility IOT and Bid Data Solution manufacture and sell non-invasive equipment, Amrita Spand


US FDA awards 510(k) clearance to EvoEndo’s Single-Use Unsedated Transnasal Endoscopy

EvoEndo, Inc. has announced the receipt of 510(k) clearance from the US Food and Drug Administration (FDA) to begin marketing and selling the EvoEndo Single-Use Endosco


Portronics introduces ear otoscope, Cleansify

Portronics, a market leader in India's digital & portable consumer electronics market space, has launched Cleansify, an ear otoscope.


US FDA authorizes new and improved Blue Light system to be operated with Photocure’s Cysview product in BLC systems to detect NMIBC

Photocure ASA declares US FDA approval of a novel and enhanced Blue Light system to be utilized with Photocure’s Cysview product in Blue Light Cystoscopy (BLC) pr


Researchers design novel fluorometric detection technology to detect pathogens, including Covid-19

In a joint research initiative, the Jawaharlal Nehru Centre for Advanced Scientific Research (JNCASR) and the Indian Institute of Science (IISc) have developed a novel


Philips' concerns increase as FDA labels expanded ventilator recall Class I event

The Philips recall concentrates on respiratory devices that feature polyester-based polyurethane (PE-PUR) sound abatement foam associated with potential health risks.&n


CCMB researchers develop new equipment and methods to detect different forms of Covid variants in advance

Scientists at the CCMB (Centre for Cellular and Molecular Biology ) in Hyderabad have designed new devices and methods to detect varied variants of coronavirus in advan


IISc-incubated startup Azooka Labs introduces mWRAPR, a novel indigenous bio-sample collection kit

A startup set by the Society for Innovation and Development at the Indian Institute of Science (IISc), Azooka Labs, introduced mWRAPR, India’s first indigenous Bi


NephroPlus aims for adequate dialysis care with apps for patients and nephrologists

NephroPlus has pitched two apps to provide dialysis patients and nephrologists much-needed support. This launch arrived as part of actions by the company to transfer it


Max Hospital Saket launches India’s first AI-based cancer treatment technology

The radiation oncology department at Max Institute of Cancer Care (MICC), Saket, introduced the latest Radixact X9 Tomotherapy in India for the first time, connected wi


US FDA awards 510(k) clearance for Avinger’s new Lightbox 3 console

According to a company announcement, the US Food and Drug Administration (FDA) has presented 510(k) clearance to Avinger’s new Lightbox 3 imaging console.


OES Medical to release new ventilator at Arab Health

UK-based anesthesia device OES Medical manufacturer is entering the ABHI UK Pavilion at Arab Health 2022 to venture a new mains-powered ICU ventilator


Walgreens releases a new interactive tool to track Covid-19 variants

Walgreens recently launched a new interactive tracking tool, the Walgreens COVID-19 Index, to detect omicron quickly and follow variant activity.


Medtronic's HawkOne recall labeled Class I, counting to Medtech's device safety problems

FDA has marked Medtronic's recall of the HawkOne Directional Atherectomy System as a Class I event.

Medtronic commenced the recall


PierianDx collaborates with Biodesix to modernize lung cancer diagnostics

PierianDx partnered with Biodesix to make its interpretation technology platform usable with the Biodesix's GeneStrat NGS genomic test. It is a blood-b


FDA endorses Abbott’s cardiac mapping system to treat cardiac arrhythmia

The USFDA ( Food and Drug Administration) approved Abbott’s new cardiac mapping platform, EnSite X EP System with EnSiteOmnipolar Technology (OT), to help physici


MobileODT releases VisualCheck algorithm for screening of cervical cancer

Israeli FemTechcompanyMobileODT has launched its next-generation VisualCheck Artificial Intelligence (AI) Algorithm for cervical cancer screening.


MicroPort CRM ensures approval for Alizea pacemakers in Japan

MicroPort CRM has obtained approval from Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) for its new Alizea pacemakers equipped with Bluetooth technolog


LumiraDx’s Covid-19 antigen test can determine Omicron variant

The LumiraDx SARS-CoV-2 Antigen test demonstrated 100% agreement with RT-PCR in FDA EUA clinical studies.

LumiraDx has declared tha


Bio-Techne partners with Akoya Biosciences to develop automated spatial multiomics workflow with industry-leading speed and resolution

Bio-Techne and Akoya Biosciences entered a collaboration to develop the first single-cell, spatial multiomics workflow for comprehensive, unbiased analysis of tissue sa


Qiagen bolsters a growing portfolio of applications for its digital PCR platform QIAcuity with fresh collaborations

Qiagen N.V. declared new additions to the growing number of applications for QIAcuity. It's an ultrasensitive digital PCR (dPCR) platform that has set new standards by


US FDA approves Copan’s Colibri automated specimen workup instrument for use with MALDI-TOF mass spectrometry analyzers

Copan Diagnostics received US FDA approval for its Colibri, an automated processing part of WASPLab, Copan’s full laboratory automation system.


Glytec and Roche signed a partnership on insulin management

This digital health collaboration connects Roche’s IT solutions and medical devices expertise with Glytec’s FDA-cleared insulin dosing decision support soft


Mylab’s CoviSelf is able to detect the Omicron variant successfully

A recent study conducted at Columbia University, USA, showed India’s first ICMR-approved self-test kit, CoviSelf, successfully detects the Omicron variant. Given


Columbia University study: Mylab’s CoviSelf can detect Omicron variant successfully

Researchers at Columbia University, USA, accomplished a recent study that revealed that India’s first ICMR-approved self-test kit, CoviSelf, successfully detects


Bioretec aims for European CE mark approval for its bioresorbable RemeOs magnesium screw

Bioretec Ltd., a Finnish medical device company, announced submitting an application for the CE mark for its RemeOs trauma screw. Bioretec aims to receive the CE mark a


US FDA endorses expanded MRI compatibility for Abbott's Proclaim XR Spinal Cord Stimulation System

Abbott announced the USFDA approval for its new expanded MRI (magnetic resonance imaging) compatibility for its Proclaim XR Spinal Cord Stimulation (SCS) System with Oc


USPTO awards Tevogen Bio’s investigational T cell therapy patent to treat Covid-19

Tevogen Bio, a clinical-stage biotechnology company, announced that the US Patent and Trademark Office (USPTO) had granted a patent of the pharmaceutical compositions of its investigational SARS-Co


FDA alerts about Log4j cybersecurity susceptibilities in medical devices

The FDA recently warned that widespread cybersecurity vulnerabilities in Apache's Java-based open source logging library could potentially allow unauthorized users to i


Siemens Healthineers acquires EUA from FDA for Covid-19 antigen self-test

The U.S. Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA) to Siemens Healthineers for CLINITEST Rapid COVID-19 Antigen Self


Quidel’s Covid-19 antigen tests can detect Omicron variants

Diagnostic healthcare products manufacturer Quidel confirmed that its antigen tests could detect the new emerging Covid-19 variants after its Sofia SARS Antigen FIA and


Sorrento declares Covistix Covid-19 virus rapid antigen detection test detects Omicron variant

Sorrento Therapeutics, Inc. reported that initial testing of Covistix on recombinant N proteins illustrated its capability to detect the Omicron variant in complement t


Withings receives FDA approval for ScanWatch to monitor vital signs

The FDA approved Withings' most medically advanced wearable, ScanWatch.

Its state-of-the-art technology can monitor heart rate, atrial fibrillation through ECG, blood oxygen levels through


Bio-Rad Laboratories introduces new SARS-CoV-2 panels

Life science research and clinical diagnostic products organization Bio-Rad Laboratories launched the IgM SARS-CoV-2 and Bio-Plex Pro Human IgA panels to detect IgM and IgA antibodies against four


Takara Bio Europe introduces an assay for SARS-CoV-2 detection

Takara Bio Europe (TBE) launched an in vitro diagnostic assay for the qualitative detection of novel coronavirus (SARS-CoV-2) from suspected COVID-19 patients, based on real-time reverse transcript


SyncThink receives additional FDA clearance for concussion aid

SyncThink, a neurotechnology company and developer of the EYE-SYNC technology, has received clearance from the Food and Drug Administration (FDA) for the EYE-SYNC technology as an aid to concussion


Medtronic's surgical robot Hugo obtains CE mark, setting up Intuitive faceoff

Medtronic gained a CE mark for its Hugo robotic-assisted surgery system in Europe, propelling it closer to competitors and market leader Intuitive Surgical.

Hugo gets CE approvals for gynec


Catalyst OrthoScience showcases imaging IT tool for preoperative planning

Catalyst OrthoScience unveiled an imaging software, Archer 3D Targeting, that aids in preoperative planning for shoulder arthroplasty.

The software developed in collaboration with a 3D-Side


Asensus Surgical receives FDA approval to boost machine vision capabilities

Asensus Surgical received USFDA’s 510(k) clearance to boost machine vision capabilities on its Intelligent Surgical Unit (ISU).

The said ISU is used for digital laparoscopy with Asens


Thermo Fisher collaborates with AstraZeneca to create companion diagnostics

Thermo Fisher Scientific’s clinical sequencing unit and AstraZeneca entered a collaboration for multiple years to create next-generation sequencing (NGS)-based companion diagnostics (CDx).


NCI researchers develop blood tests for early detection of cancer in NF1 patients

Researchers at NCI's (National Cancer Institute) Centre for Cancer Research and Washington University School of Medicine have come up with a blood test to detect cancer early in people with neurofi


Zymo Research's SafeCollect receives a CE mark

Zymo Research received a CE mark for its novel at-home sample collection kits for sale in the EU (European Union).

The SafeCollect Sample Collection Kits offer customers safety and utility


FDA approves Zimmer and Canary's smart knee implant

The USFDA (Food and Drug Administration) granted De Novo classification and authorization to Zimmer Biomet and Canary Medical to market the tibial extension for Persona IQ for total knee replacemen


HMD launches next-generation 3-way stop cock, Dispoway

HMD (Hindustan Syringes and Medical Devices), one of the top five manufacturers of syringes and needles worldwide, has introduced Dispoway, a new and improved 3-way stop cock for infusing more than


New Respirator masks kill SARS-CoV-2 on contact

Lancaster-based ViraCoat Limited announced the global launch of a new range of antiviral and antimicrobial personal protective equipment (PPE) masks that could kill SARS-CoV-2 and other viruses on


FDA approves Medtronic’s new TAVR system to treat aortic stenosis

The USFDA approved Medtronic’s latest self-expanding TAVR (transcatheter aortic valve replacement) system to treat symptomatic severe aortic stenosis.

The Evolut FX TAVR system is eas


Mackwell Health partners with GE Current for LED UV disinfection tech

Mackwell Health and GE Current announced a collaboration in the field of LED UV disinfection technology. The partnership will spread Current's 365DisInFx UV Technology to the Middle Eastern, Europe


Abingdon launches BioSure 20-minute result antibody test

Abingdon Health, a global developer and manufacturer of rapid tests, launched the BioSURE COVID-19 IgG Antibody Self Test.

BioSure, UK, is the legal manufacturer of the test that uses a fra


Mustang Bio signs licensing pact with Mayo Clinic for novel CAR T technology

Mustang Bio, a clinical-stage biopharmaceutical company, declared that the company had implemented an elite license agreement with Mayo Clinic for innovative technology. The technology may reconstr


Medtronic introduces a DCB catheter for CAD in Europe

On receiving the CE mark, Medtronic has introduced its DCB (drug-coated balloon) catheter, Prevail, in Europe to treat CAD (coronary artery disease) patients.

Prevail DCB is useful in percu


MeMed COVID-19 Severity test receives a CE mark

A host response-based technologies specialist, MeMed, received the CE Mark in Europe for its new disease management solution, MeMed COVID-19 Severity.

The test measures multiple proteins fr


Orthofix Medical introduces fiber bone-graft solution

Orthofix Medical launched its fiberFuse Strip, an advanced demineralized bone-graft solution comprising cancellous bone.

The latest fiberFuse Strip is a preformed bone-graft strip for poste


Cepheid gets CE-IVD clearance Xpert HIV-1 viral load XC &Xpert HIV-1 Qual XC for HIV-1 tests

Cepheid declared that it had received CE-IVD approval for Xpert HIV-1 Qual XC and Xpert HIV-1 Viral Load XC, next-generation extended-coverage (XC) tests for HIV testing.

Xpert HIV-1 Viral


Medtronic’s AI algorithms for cardiac monitoring get FDA nod

The USFDA (Food and Drug Administration) approved Medtronic’s two artificial intelligence (AI) algorithms for use with the LINQ II insertable cardiac monitor (ICM).

The AccuRhythm AI


Abbott launches Jot Dxinsertable cardiac monitors in the US market to detect abnormal heart rhythms.

Abbott announced the US introduction of Jot Dx, the company's newest insertable cardiac monitor (ICM). The Jot Dx ICM provides clinicians and hospitals command of how they control data flow through


J&J Vision launches a new system for cataract surgery

Johnson & Johnson (J&J) Vision launched its phacoemulsification (phaco) system worldwide. The VERITAS Vision System intends to provide surgeons with improved efficiency and comfort during c


IBM and NanoDx to develop nanoscale sensors for rapid diagnostic testing

NanoDx collaborated with IBM Research to use its metal-oxide semi-conductive (CMOS) compatible nanoscale sensors to boost and extend accurate, rapid testing for various indications.

The com


Bio-Rad launches COVID & Flu PCR kit

A life science research, and clinical diagnostic product provider, Bio-Rad Laboratories, has launched the "Reliance SARS-CoV-2/FluA/FluB RT-PCR Kit (IVD)" for EU markets after CE-IVD mark approval.


A biochip for coronavirus testing is coming soon

The Research Institute of Rospotrebnadzor has started working on the development of a biochip for COVID-19 testing. 

Rospotrebnadzor published the outcomes of studies of the COVID-19 i


FDA awards breakthrough device classification to Endologix’s ChEVAS System

The US Food and Drug Administration (FDA) awarded breakthrough device designation to Endologix’s ChEVAS (Chimney EndoVascular Aneurysm Sealing) System for treating abdominal aortic aneurysm (


DePuy Synthes introduces robotic-assisted knee surgery solution in Australia

Johnson & Johnson's orthopedics company, DePuy Synthes, originated its VELYS Robotic-Assisted Solution for knee replacement surgery in Australia.

VELYS is to be used with the company's


ROSA Knee System presents a highly customized surgery experience

Patients experiencing total knee replacement at Mater Private Network in Cork could benefit from faster recovery times and an extra customized overall experience, introducing the new ROSA Knee Syst


Intelligent Fingerprinting creates saliva-based Covid-19 antigen test

Intelligent Fingerprinting, UK, has created a user-friendly, saliva-based lateral flow VSS-GP test for rapid SARS-CoV-2 antigen detection.

The current Covid-19 tests require invasive nose a


ISTAR Medical gets an FDA nod to initiate a trial of MINIject for glaucoma

iSTAR Medical received IDE (investigational device exemption) from the USFDA (Food and Drug Administration) to begin a clinical trial of its MINIject, a minimally invasive implant for glaucoma surg


Canon Medical and Cleerly to produce heart disease solutions

Canon Medical Systems, USA, has subscribed to a decisive collaboration with Cleerly to facilitate simple and effective cardiac computed tomography (CT) to grant a new standard of care for heart ail


The recalled Philips sleep apnea ventilator was classified as Class I by FDA

The FDA officially labeled Philips' recall of sleep apnea and ventilator devices a Class I event, about one month after the company's announcement. The agency put out two separate notices Thursday


NuVasive introduces 3D-printed porous titanium implant for spine surgery

NuVasive launched a new 3D-printed porous titanium implant, Modulus ALIF, for anterior lumbar interbody fusion (ALIF) procedures in certain countries.

The device strengthens the company&rsq


Scottish consortium to use AR to upskill surgeons on 3D-printed models

A Scottish syndicate is launching an AR (augmented reality) tool to help train surgeons on hyper-real 3D-printed models of human organs.

The software will guide trainee surgeons while


B-Secur partners with Texas Instruments for ECG/EKG monitoring

B-Secur has launched an ECG (electrocardiogram) solution based on the TI's (Texas Instruments) AFE4950 analogue front end for photoplethysmography (PPG). The new ECG sensing will accelerate the des


Unilabs and Ibex collaborate to implement an AI cancer platform in Europe

Unilabs, a diagnostic services provider, and Ibex Medical Analytics, a specialist in AI-powered cancer diagnostics, have collaborated to implement Ibex's AI platform in Europe.

Starting wit


Omniscient’s brain mapping platform receives FDA grants 510(k) clearance

Quicktome, Omniscient Neurotechnology’s (o8t) digital brain mapping platform, received the USFDA (Food and Drug Administration) 510(k) clearance for neurosurgery.

A neurosurgical plan


Philips’ IVC filter removal device receives FDA breakthrough status

The USFDA (Food and Drug Administration) granted breakthrough device designation to Royal Philips’ laser-assisted IVC (inferior vena cava) filter removal device.

The device helps in a


Quibim joins a business alliance to develop a total-body PET scanner

Quibim has entered a temporary business association (TBA) with molecular imaging companies to develop a total-body PET (positron emission tomography) /CT (computed tomography) scanner for simultane


BD's Velano acquisition to enable needle-free blood draw

Becton, Dickinson, and Company (BD) plan to introduce a 'One-Stick Hospital Stay' approach by using its expertise in blood collection and vascular access solutions.

The company will us


NeuroMetrix’s fibromyalgia device gets FDA breakthrough status

The USFDA (Food and Drug Administration) has granted breakthrough device designation to NeuroMetrix’s Quell device to treat fibromyalgia symptoms in adults.

A transcutaneous electrica


Miiskin launches an AR-powered new mole sizing feature

Miiskin, a digital health app, which helps people track modifications in their skin, including existing and new moles, has come up with a new mole sizing feature that allows patients to check chang


Owlstone Medical declares findings of mask filter alternative to NPS

Owlstone Medical, a Breath Biopsy specialist for early disease detection and precision medicine applications, has published peer-reviewed research in Nature Scientific Reports. The paper examines t


Medtech enterprise TestCard introduced a new ‘Test and Treat’ service utilizing its at-home UTI test kit in partnership with Dears Pharmacy

As per experts, the waiting times for UTI treatment can be within 3-5 days, and undiagnosed UTIs have risen during the pandemic due to the limited access to GP appointments.

Now with this n


A molecular, point-of-care Covid-19 test from Cue Health receives CDSCO approval

Cue Health, a healthcare technology company, announced receiving regulatory approval from CDSCO (Central Drugs Standard Control Organization) for its Cue Covid-19 Test for professional point-of-car


Hologic obtains CE mark for saliva specimens on COVID-19 assay

Hologic has received a CE Mark for Aptima SARS-CoV-2 assay in Europe to utilize saliva samples. The test is a molecular diagnostic assay that identifies the pathogen's genetic material causing COVI


BPR Medical's medical gas solutions receive MDSAP certification

UK-based independent manufacturer of medical gas products, BPR Medical, received MDSAP (Medical Device Single Audit Program) certification for its medical gas solutions. 

Only a few me


FDA approves Stryker’s biodegradable subacromial balloon implant

The USFDA (Food and Drug Administration) has approved Stryker’s InSpace balloon implant for arthroscopic therapy of MIRCTs (massive irreparable rotator cuff tears) for sustained improvements


Seegene launches a new test to distinguish SARS-CoV-2 variants

South Korea-based biotech Seegene has introduced a new multiplex PCR (polymerase chain reaction) test to screen for six emerging SARS-CoV-2 variants, including the Delta and Delta Plus variants.


Philips partners with NICO.LAB to enhance stroke care

Royal Philips inked a strong collaboration dealing with a MedTech stroke care company, NICO.LAB to intensify results in stroke patients.

The contract will complement the extensive stroke ab


GE Healthcare and SOPHiA ally to develop AI-driven cancer solutions

GE Healthcare and SOPHiA GENETICS inked a letter of intent to operate together on targeting and coordinating therapies that can accommodate unique patient’s genomic profiles and cancer types.


Thermo Fisher and Ortho Clinical associate to provide quality control products

Thermo Fisher Scientific has partnered with Ortho Clinical Diagnostics to supply its MAS Quality Controls and LabLink xL Quality Assurance Software to be used with the latter’s VITROS analyze


PocDoc and PATH associate in a bid to eradicate polio

PocDoc and PATH will produce an app-based digital reader for primary immunodeficiency diseases (PID) to help scale PID rapid testing and support the rollout of polio vaccinations across the world,


Siemens’ MAGNETOM Free.Max MR scanner gets FDA approval

The USFDA (Food and Drug Administration) approved Siemens Healthineers’ MAGNETOM Free.Max, a High-V MR (magnetic resonance) scanner.

The device merges a 0.55 Tesla field strength with


Quidel obtains a CE mark for a multiplex analyzer and a respiratory viral panel

Quidel has obtained a CE mark for its Savanna multiplex molecular analyzer and Savanna Respiratory Viral Panel-4 (RVP4) Assay.

The approval allows marketing and sale of the Savanna system i


Launch of Panbio Covid-19 antigen self-test in India: Abbott

Abbott declared the launch of Panbio Covid-19 antigen self-test to detect the SARS-CoV-2 virus in grown-ups and children with or without signs. In line with the current ICMR guidelines on self-use,


SDSOS produces a battery-operated reusable mask to shield from airborne human pathogens

Sunandan Divatia School of Science (SDSOS), Mumbai, originated a battery-operated reusable mask to protect from airborne human pathogens.

The technology is transferred to Mumbai-based Milto


An app that could reduce the post-surgery complication rates to halve launched

Digital therapeutics pioneer my mhealth has declared the launch of its latest app, myOp, which can halve post-surgery complication rates and better recovery times for even the greatest-risk patient


Philips and Spanish CNIC to generate cardiac MR imaging protocol

Royal Philips has partnered with the Spanish National Center for Cardiovascular Research (CNIC) to create a new cardiac MRI (magnetic resonance imaging) technique.

Named "ESSOS" (Enhanced S

10-07-2021 obtains a CE mark for AI-based stroke care software got a CE mark to sell "Viz LVO," an artificial intelligence (AI)-driven stroke care software.

The clinical data reveals that software can coordinate stroke care, reduce treatment tim


Qiagen’s NeuMoDxHAdV quant assay gets European CE-IVD label to identify human adenovirus infections

Qiagen declared that its NeuMoDxHAdV Quant Assay to identify and quantify human adenovirus (HAdV) DNA had obtained CE-IVD certification for the European Union and additional countries that allow th


Blackfrog Technologies develops compact refrigeration device ‘Emvolio’ for carrying vaccines

The Blackfrog Technologies, a startup supported by the Department of Biotechnology-Biotechnology Industry Research Assistance Council (DBT-BIRAC), has developed Emvolio. This portable, battery-oper


Quidel COVID-19 PCR recall entitled Class I by FDA due to false-negative risk

Quidel obtained emergency use authorization for its Lyra assay on March 17 of last year, presenting it as one of the primary companies to bring a SARS-CoV-2 test to market in the U.S. A rapid antig


FDA awards breakthrough device rank to Hyalex’s cartilage system

he US Food and Drug Administration (FDA) granted breakthrough device designation to Hyalex Orthopaedics’ cartilage system for fixing cartilage deformities.

The HYALEX Cartilage System


FDA approves Natural Cycles app for birth control wearable

Natural Cycles, the novel FDA-cleared birth control app, has received new FDA clearance to revise its labeling and expand the types of third-party thermometers, including consumer wearable already


Test detecting COVID-19 within 20 seconds undergoes MHRA registration

A pathogens diagnostic device able to detect SARS-CoV-2 within 20 seconds, SpectraLIT, is undergoing MHRA registration and may shortly be available in the UK.

The device uses mass spectrome


QuantuMDx launches Q-POC, a rapid PCR system

UK-based developer, QuantuMDx, launched Q-POC - a rapid, PCR point of care diagnostic system. Q-POC received a CE-IVD mark under the In Vitro Diagnostics Directive (98/79/EC), enabling its use in E


FDA labels Medtronic's recall of unsterilized angiography guidewires as Class I

Medtronic recalled 54,997 guidewire components used during angiography to place catheters into the vascular system for sterilization issues before being shipped to hospitals. FDA ter


FDA validates AliveCor’s ECG device for QTc interval measurement

The US Food and Drug Administration (FDA) awarded 510(k) approval to AliveCor’s electrocardiogram (ECG) device, KardiaMobile 6L, for the measurement of QTc interval in patients by healthcare


FDA signals biocompatibility issues linked to NuVasive's Precice devices

FDA signaled healthcare providers regarding likely biocompatibility concerns related to NuVasive's stainless steel and titanium Precice orthopaedic appliances. The machines are used to extend the l


FDA awards EUA to BioGX’s direct sample RT-PCR Covid-19 test

The US Food and Drug Administration has awarded Emergency Use Authorisation (EUA) to BioGX’s direct sample addition Xfree COVID-19 reverse transcription-polymerase chain reaction (RT-PCR) tes


CDSCO demands Philips India to discontinue continuous & non-continuous ventilators

The Central Drugs Standard Control Organisation (CDSCO) medical devices and diagnostics division ordered Philips India Limited to discontinue continuous and non-continuous ventilators because of so


Vivalink introduces an enhanced ECG monitor

Vivalink, a provider of coupled healthcare solutions, has originated an afresh enhanced temperature and cardiac electrocardiogram (ECG) monitor.

The new temperature monitor constituted an o


Front Line receives FDA approval for COBRA-OS device

The FDA (Food and Drug Administration) approved Control of Bleeding, Resuscitation, Arterial Occlusion System (COBRA-OS) from Front Line Medical Technologies.

The COBRA-OS is the first 4 Fr


Novacyt plans to launch a couple of new lateral flow tests

The clinical diagnostics specialist, Novacyt, is launching two PathFlow COVID-19 antigen lateral flow tests (LFTs) to bolster its COVID-19 portfolio and to pursue new market opportunities, especial


Abbott's Panbio Self-Test to detect the Covid-19 virus receives a CE mark

Abbott's Panbio COVID-19 Antigen Self-Test received a CE mark. Panbio aims to identify the SARS-CoV-2 virus in adults and children with or without symptoms. The CE mark allows over-the-counter sale


The US FDA grants pre-market approval to Abiomed's heart pump

Abiomed's Impella RP with SmartAssist got pre-market approval (PMA) from US FDA (Food and Drug Administration). Impella RP is a heart pump that aims to treat acute right heart failure. 



India's first AI-enabled smart virtual nutrition mentor app 'Fitza' originated in the market

Fitza, a pioneer in the digital fitness market; a one-of-a-kind mobile application to touch people's experiences by holistic health and nutritional well-being, leveraging advanced technology. The a


SP introduces SP Hull LyoStar 4.0 R&D freeze dryer to intensify business in drug development

SP Industries, Inc. (SP) declared the launch of its SP Hull LyoStar 4.0 R&D and process development freeze dryer devised and developed to improve the market of biopharmaceutical products, such


J&J Vision launches TECNIS Synergy & TECNIS Synergy Toric II PC-IOLS in the US & Canada for cataract patients

Johnson & Johnson Vision declared the availability of TECNIS Synergy and TECNIS Synergy Toric II IOLs in the US and Canada. These next-generation PC-IOLs blend the extensive depth of focus and


Wipro GE Healthcare commences local manufacturing of its Versana Ultrasound series in India

Wipro GE Healthcare intensified its local capacity to manufacture a wide variety of Versana products in India. The initiative is a part of the company’s plan to extend localization and encour


Wipro GE Healthcare commences local manufacturing of its Versana Ultrasound series in India

Wipro GE Healthcare intensified its local capacity to manufacture a wide variety of Versana products in India. The initiative is a part of the company’s plan to extend localization and encour


Max@Home links up NephroPlus to start home hemodialysis services

Max Healthcare's Max@Home service has partnered with NephroPlus to begin a novel initiative to give patients dialysis services at their doorsteps.

This unprecedented partnership brings both


QIAGEN launches QIAprep& CRISPR Kit and CRISPR Q-primer solutions for speedy and simplified investigation of gene-editing examinations

QIAGEN declared the launch of QIAprep&amp CRISPR Kit and CRISPR Q-Primer Solutions that enable researchers to examine edited genetic material with unmatched pace and competence to ascertain how


Thermo Fisher launches CE-IVD labeled TaqPath Covid-19 swift PCR combo kit 2.0

Thermo Fisher Scientific declared the introduction of a novel CE-IVD marked Covid-19 test. The TaqPath Covid-19 Fast PCR Combo Kit 2.0 extends Thermo Fisher's series of high-precision tests to dete


Sensome’s Clotild Smart Guidewire system to treat ischemic stroke: US FDA breakthrough therapy status

Sensome declared that the Center for Devices and Radiological Health had awarded it a Breakthrough Device designation of the Food and Drug Administration (FDA) for it


Avacta signs distribution deal with Calibre Scientific for AffiDX SARS-CoV-2 antigen lateral flow test in UK and EEA

Avacta Group declares a non-exclusive distribution agreement with Calibre Scientific for Avacta's AffiDX SARS-CoV-2 antigen lateral flow test for licensed use in the UK and European Economic Area (


Algorithmic Biologics for gold-standard RT-qPCR test, Tapestry: gets DCGI nod

Algorithmic Biologics, a Bengaluru-based deep-tech startup producing algorithmic innovations to molecular analysis, received the Drugs Controller General of India (DCGI) approval for commercial use


Implandata’s Eyemate-SC biosensor for distant glaucoma care gets CE marking

Implandata Ophthalmic Products has declared that its Eyemate-SC biosensor has received CE Mark. This tool is used in association with the breakthrough Eyemate system for digitally-enabled remote gl


Launches AI face recognition temperature screening product for early isolation of infected individuals: Globus Infocom

Globus Infocom has recently inaugurated its latest AI face identification temperature screening commodity for the initial separation of infected people. It also has an access controller arrangement


Logix Smart SARS-CoV-2 Direct Saliva test obtains CE marking: Co-Diagnostics

Co-Diagnostics, Inc. declared that its Logix Smart SARS-CoV-2 DS (Direct Saliva) had received regulatory authorization to be traded as an in vitro diagnostic (IVD) for the Covid-19 diagnosis in mar


New Light Technique Could Change Imaging

A trio of scientists from the University of Exeter has uncovered a novel approach to manage the light that the way has scrambled through a single hair-thin strand of optical fibers. These ultra-thi


Smart Meter launches cellular-connected body weight scale: iScale

Smart Meter, one of the leads in cellular-enabled distant patient monitoring data and tools, declared the introduction of iScale, a cellular-connected body weight scale. This extension extends its


Bayer's Astepro allergy nasal spray for respiratory allergies in the US: US FDA approval

Bayer's Astepro Allergy (Azelastine HCI .15%) got the US Food and Drug Administration (FDA) had approval as an OTC (over-the-counter) product for the temporary relief of runny nose, sneezing, nasal


Researchers devised a device to diagnose pregnancy complications by monitoring the oxygen level of the placenta: NIH

Scientists at the NIH (National Institutes of Health) have produced a model tool that could probably diagnose pregnancy complexities by watching the oxygen level of the placenta. The equipment tran


UK extends EUA (Exceptional Use Authorisation) for Innova’s Covid-19 rapid test amid FDA refusal

The US FDA alerted the public against the use of Innova’s Covid-19 test, citing health hazards.

The UK MHRA (Medicines and Healthcare products Regulatory Agency) has extended the EUA


Vuram introduced the live tracking app 'Trackable' for Covid vaccine allocation

Vuram has originated an innovative app to trace Covid essentials such as vaccines, PPE, oxygen cylinders, and masks. Trackable is the first of its kind Appian live tracking app, and Vuram's team be


Gait deficit device treatment for MS patients: FDA authorization

Helius Medical Technologies and Cambridge Consultants, part of Capgemini, declared that a device - Portable Neuromodulation Stimulator (PoNS), designed for short-term treatment of gait deficit due


Gait deficit device treatment for MS patients: FDA authorization

Helius Medical Technologies and Cambridge Consultants, part of Capgemini, declared that a device - Portable Neuromodulation Stimulator (PoNS), designed for short-term treatment of gait deficit due


Medtronic's HeartWare HVAD pump recalls, and the declaration to exit

Medtronic abruptly removed its HeartWare Heart Ventricular Assist Device pump system from the market after a range of Class I recalls in 2021 and reports of patient harms and deaths associated with


Medtronic launches Micra AV, the world's smallest pacemaker with AV synchrony to treat heart block in patients in India

India Medtronic Private Limited, a wholly-owned subsidiary of Medtronic plc, announced the launch of Micra AV - a miniaturized, fully self-contained pacemaker that delivers advanced pacing technolo


Circle CVI and DiA Imaging collaborate to deliver AI-based all-in-one cardiac imaging solutions

DiA Imaging Analysis Ltd., and Circle Cardiovascular Imaging Inc., declared a multi-year alliance leveraging the companies' synergies in cardiac AI and data analytics.

As a global leader in


Launch of Amplatzer Piccolo Occluder device in India for treatment of premature babies and newborns: Abbott

Abbott introduced its Amplatzer Piccolo Occluder in India, the world's first medical device that can be implanted in the tiniest babies (weighing as little as 700 gms) using a minimally invasive pr


Avacta lateral flow test registered in EU

Avacta has obtained notification of registering its AffiDX SARS-CoV-2 antigen lateral flow test in the EU, enabling the company to place the product on the market in all 27 countries for acknowledg


Health risks cause Philips to recall sleep and respiratory care products

Royal Philips voluntarily recalled breathing devices and ventilators after discovering possible health risks linked to the PE-PUR (polyester-based polyurethane) sound abatement foam used in them.


Verily fails to get FDA approval for its wrist-worn Parkinson's clinical trial device

FDA has rejected Verily's (Google's sibling company) request to use a wrist-worn wearable device that aims to trace changes in the motor symptoms of clinical trial patients with Parkinson's disease


Medtronic receives FDA approval for a recharge-free neurostimulator

Medtronic received U.S. Food and Drug Administration (FDA) approval for its recharge-free implantable neurostimulator (INS), Vanta. It is a device with an optimized life of up to 11 years.


Ibex Medical’s AI breast cancer solution receives CE mark

Ibex Medical Analytics, an AI-powered cancer diagnostics firm, has received the CE mark for the Galen Breast solution to support pathologists in detecting various types of breast cancer. 


Quest Diagnostics collaborates with Paige to develop cancer diagnostics

Quest Diagnostics and Paige have collaborated to develop software products leveraging AI (artificial intelligence) to enhance and expedite the pathologic diagnoses of cancer and various other disea


Photonics is planning to reinvent the Apple Watch for health tracking

Rockley Photonics plans to develop a technology that enables the Apple Watch to track blood glucose levels non-invasively.

All clients of Rockley Photonics, like Apple Inc., are developing


FDA clears two endoscopes that avoid reprocessing

FDA approved two new single-use, disposable endoscopes, less than two months after again cautioning healthcare providers to be aware of contamination issues and infection risks tied to versions of


Migration risk causes recall of venous stents by Boston Scientific

Boston Scientific is recalling all Vici RDS and Vici SDS venous stent systems sold over the last 30 months because of 17 complaints about the products.

Users complained that the devices mig


HSA Singapore gives provisional approval to Breathonix's Covid-19 breath test

Singapore's Health Sciences Authority (HSA) provisionally authorized Breathonix's BreFence Go COVID-19 Breath Test System for accurate disease identification in a minute. Breathonix, a spin-off fir


EmpowerDX at-home Covid-19 test for children receives EUA from FDA

The US Food and Drug Administration (FDA) has granted emergency use authorization (EUA) for the at-home Covid-19 testing kit for children aged three years and above by Eurofins Scientific subsidiar


IISc incubated PathShodh receives DCGI approval for the ELISA Covid-19 test kit after THSTI validation

PathShodh Healthcare, a start-up nurtured at the Society for Innovation and Development (


Ortho Clinical Diagnostics launches quantitative Covid-19 IgG spike antibody test and nucleocapsid antibody test to help distinguish the cause of antibody response

Ortho Clinical Diagnostics launched the first quantitative Covid-19 IgG antibody test in addition to a complete Covid-19 nucleocapsid antibody test.

Ortho is the first company offering labo


CE Mark approval for OrbusNeich Medical’s TricValve Transcatheter Bicaval Valves System

The TricValve Transcatheter Bicaval Valves System, from the joint partnership of OrbusNeich Medical Company Ltd and P&F Products & Features (OrbusNeich P&F), received CE mark approval.&


Philips launches the latest Spectral Computed Tomography 7500 system

Royal Philips launched a spectral detector-based Spectral Computed Tomography (CT) 7500, the latest solution for precision diagnosis. 

This new system intelligently delivers high-quali


BD launches an IVD immunoassay application to assist in patient management decisions in Covid-19

Becton, Dickinson and Company launched its BD Multitest 6-Color TBNK Reagent with BD Trucount Tubes with an expanded clinical application in India. 

It aims to identify Covid-19 patien


Chugai's FoundationOne Liquid CDx Cancer Genomic Profile to be used as a companion diagnostic for Lynparza to treat BRCA- mCRPC: Japanese approval

Chugai pharmaceutical obtained approval from the Ministry of Health, Labour and Welfare (MHLW) for FoundationOne Liquid CDx Cancer Genomic Profile to be used as a companion diagnostic for the PARP


COVID-19 antibody detection kit development: DRDO

A laboratory of Defence Research and Development Organisation (DRDO)-Defense Institute of Physiology and Allied Sciences (DIPAS), has developed an antibody detection-based kit, 'DIPCOVAN,' the DIPA


Medtronic HeartWare system hit with several Class I recalls, device reports since 2012 PMA

A slew of recalls has hit Medtronic's HeartWare HVAD pump system recently. Since it's been on the market, the rate of device malfunction reports documented in an FDA database outpaces competing pro


A new electrochemical device to identify SARS‑CoV‑2 Spike Protein in a second

Researchers at the University of Florida and the National Chiao Tung University in Taiwan have developed a microfluidic device to detect the SARS‑CoV‑2 spike protein in saliva samples within on


Intersect ENT's PROPEL Contour sinus implant: receives CE mark

Intersect ENT's PROPEL Contour (mometasone furoate) sinus implant obtained a CE mark promoting its supply and marketing within the European Union.

The implant is outlined to preserve patenc


Mylabs' COVISELF, home testing kit for COVID-19, gets ICMR approval

The ICMR has approved Pune-based Mylabs' new self-use rapid home-test kit for Covid-19. The new kit can generate results in just 15 minutes.

Named 'COVISELF,' the country's first Covid-19 h


Google launches a novel AI tool to detect dermatological conditions

Google introduced an AI-powered dermatology assist tool that uses a phone's camera to detect skin, hair, and nail conditions. 

The internet-based application requires three images of t


Orthofix launches a new Ultrasonic arthroplasty revision system in Europe and U.S.

Orthofix Medical launched OSCAR PRO Ultrasonic Arthroplasty Revision System in the U.S. and European market.

OSCAR PRO is an ultrasonic surgical system used to amend


Abbott receives CE marking for Navitor (TAVI system) to treat aortic stenosis

Abbott got CE Mark for its new-age TAVI (transcatheter aortic valve implantation) system, Navitor, to treat severe aortic stenosis. The latest minimally invasive device can mitigate the high or ext


ACON's Flowflex test receives CE certification for self-testing

ACON's Flowflex SARS-CoV-2 Antigen Rapid Test received CE mark approval for self-testing. The CE certificate issued by TUV SUD (CE0123) is valid from 14th May 2021 to 26th May 2024. 



CareNiva to improve the level of patient care with its new AI-driven telehealth platform

Telehealth Company, CareNiva, introduced an artificial intelligence (AI)-driven Telehealth platform to deliver a global healthcare solution for providers. The physician can easily and seamlessly pr


AI-driven Blood Glucose Prediction Analysis Engine receives CE Mark approval

One Drop secured CE Mark (Conformité Européenne) for its AI-based Blood Glucose Prediction Analysis Engine. The new device can accurately forecast glucose levels up to eight hours in


Philips brings an integrated Interventional Hemodynamic System with Patient Monitor IntelliVue X3 to enhance workflow and patient focus throughout image-guided procedures.

Royal Philips introduced an integrated system comprising its Interventional Hemodynamic System and market-leading portable Patient Monitor IntelliVue X3. The integration provides advanced hemodynam


Electrical shorts cause recall of Abbott's Assurity, Endurity pacemakers

Abbott plans to recall 61,973 Assurity and Endurity pacemakers from the U.S. due to electrical shorts resulting in problems like loss of telemetry, loss of pacing, and reduced battery life. FDA sta


Magnets in certain cell phones and smartwatches may cause pacemakers, other implanted devices to malfunction: FDA

FDA raised a public warning for patients using pacemakers and other implanted medical devices. The agency warned that high-strength magnets in some cell phones and smartwatches could alter these de


The Linea Covid-19 Assay Kit from Applied DNA Sciences Inc. gets EUA from USFDA

The USFDA (US Food and Drug Administration) granted a re-issued EUA (Emergency Use Authorization) to Linea Covid-19 Assay Kit from Applied DNA Sciences Inc. The Assay Kit’s use now includes a


Nasopharynx 3D printed swabs may help streamline COVID-19 tests

A new 3D printed COVID-19 testing swab is now being manufactured in Scotland. It can collect adequate viral material from the back of the nose - without requiring a throat swab. 

The n


Glooko collaborates with Eli Lilly for connected insulin pens

Eli Lilly entered a collaboration with remote patient monitoring and data management solutions provider, Glooko for its connected insulin pen solutions.

The partnership aims for better


Neurolutions' Device receives USFDA approval

USFDA has authorized the use of Neurolutions' device in stroke patients. It can help in regaining movement in the hand, wrist, and arm through brain-computer interface.

It is a non-invasive


Wearables are not helpful for clinicians

Forrester Research's report on wearables in the healthcare sector suggested these devices have numerous shortcomings. Interviews from more than 40 physicians and patients were taken before the repo


ROCHE's VENTANA MMR RxDx Panel receives USFDA approval

The USFDA granted approval to Roche's VENTANA MMR RxDx Panel. It will act as a companion diagnostic (CDx) for the identification of advanced or recurrent endometrial cancer patients.

It is


Medtronic receives FDA nod for its embolization device with shield technology

The (USFDA) United States Food and Drug Administration approved Medtronic’s Pipeline Flex Embolization Device with Shield Technology. The Shield Technology introduces a surface-modified impla


Implantable Pump Delivers Chemotherapy to Brain Tumors

An electrical pump has been developed to deliver a precise amount of therapeutic drug into the brain. It can be implanted into brain tumor resection sites for an extended period for drug delivery.<


Wireless sensor for oxygen level monitoring

Researchers at Berkeley's University of California, designed an ultrasound-powered implantable sensor to monitor oxygen levels and transmit the information into an external device.

An on-bo


AMS receives a CE mark for Seal-G MIST, the laparoscopic GI sealant device

The surgical and advanced wound care specialist company, Advanced Medical Solutions (AMS) Group, received CE mark approval for its laparoscopic gastrointestinal (“GI”) sealant device, S


Thermo Fisher Scientific's new automated system for COVID-19 tests receives FDA's EUA

The U.S. Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA) to Thermo Fisher Scientific Amplitude Solution with the TaqPath COVID-19 High-Throughput Combo Kit.



Philips, Ibex Medical Analytics sign collaboration to jointly promote AI-powered digital pathology

Royal Philips, a global leader in health technology, and

Ibex Medical Analytics, a leader in artificial intelligence (AI) based cancer diagnostics, announced a strategic collaboration for p


6 Medtronic HeartWare products recalled because of death reports.

FDA has classified another set of products recalled related to Medtronic’s HeartWare HVAD ventricular assist device as a Class I event after receiving reports of deaths associated with the is


TriClip device receives CE Mark approval: Abbott

Abbott announced it had received CE Mark for its next-generation TriClipTranscatheter Tricuspid Valve Repair System to treat TR (tricuspid regurgitation). The system is known as TriClip G4, is a no


Bausch + Lomb’s ClearVisc dispersive ophthalmic viscosurgical device gets US FDA approval

Bausch + Lomb announced that the US Food and Drug Administration (FDA) had approved ClearVisc dispersive ophthalmic viscosurgical device (OVD) for ophthalmic surgery use.

OVDs help in intra


Suit alleging Medtronic over spine fusion can proceed, appeals court says: misled FDA

A whistleblower lawsuit accusing Medtronic of fraudulently obtaining FDA clearance for several spinal fusion devices can proceed, the U.S. 9th Circuit Court of Appeals has ruled. The plaintiffs &md


Patient deaths tied to reusable urological endoscopes: FDA warns

The FDA is probing more than 450 reports of patient infection and contamination associated with reprocessed urological endoscopes during the past four years, including three deaths outside the U.S.


RNA/DNA Shield Collection Tube for Covid-19 testing gets 510(k) clearance from US FDA: Zymo Research


Zymo Research declares the US Food and Drug Administration (FDA) clearance of its RNA/DNA Shield Collection Tube as a Class II medical device. The FDA’s 510(k) clearance enable


Launch of qRT-PCR in vitro diagnostic kit to detect SARS-CoV-2 RNA: Agilent

Agilent Technologies announced the launch of a real-time reverse transcription (qRT) PCR-based diagnostic kit to detect SARS-CoV-2 RNA. The CE-IVD mark follows the European Union in Vitro Diagnosti


Philips and openDoctor collaborate to deliver unprecedented digital front door experience in radiology.

Royal Philips and US-based openDoctor declared a partnership to offer an integrated radiology patient engagement platform that advantages openDoctor's real-time online appointment scheduling servic


Rigenerand collaborates with Lacopa to distribute VITVO 3D cell culture technology


Rigenerand SRL, the biotech company, inks the distribution agreement with


Launch of remote neuromodulation patient-care technology, NeuroSphere Virtual Clinic in US: Abbott


Abbott launched the NeuroSphere Virtual Clinic in the US, allowing patients to ensure proper settings and functionality, communicate with physicians, and receive new treatment settin


Scaling up technology & mobile app to train healthcare professionals involved in vaccination: Digital Jalebi

Digital Jalebi is considering scaling up the technology and a mobile-based app that trains healthcare professionals to use augmented reality (AR). The app aims to address the shortage of healthcare


App-based treatment for urinary incontinence- as effective as in-person treatment


According to new research from the Netherlands, a mobile app called URinControl was as effective as usual, in-person treatment of urinary incontinence in primary care for women.


New mobile app: diagnoses glaucoma

Scientists from City, University London, supported by Allergan Pharmaceuticals and Glaucoma UK, have launched the latest version of an app for newly diagnosed glaucoma patients.

The launch


Abbott's Alinity m Resp-4-Plex molecular assay gets US FDA EUA


Abbott announced the US FDA EUA (Emergency Use Authorization) for Alinity


T-Detect COVID Test gets Emergency use authorization from FDA

The U.S. FDA granted an emergency use authorization (EUA) for the T-Detect COVID Test developed by Adaptive Biotechnologies. The T-Detect COVID Test is an NGS (next-generation sequencing-based) tes


Launch of screening machine, Kribado for healthcare practitioners in diagnosing, treating patients at pre-admission level: Indigital Technologies

Indigital Technologies has launched a hand-held screening machine, Kribado that will help healthcare practitioners diagnose and treat patients at the pre-admission level.

Kribado is th


Luminex's expanded NxTAG Respiratory Panel Test Including SARS-CoV-2: US FDA Emergency Use Authorization and CE Mark

Luminex Corporation had received Emergency Use Authorization (EUA) for a new expanded version of its NxTAG Respiratory Pathogen Panel (RPP), including the SARS-CoV-2 virus for high-throug


Launches first portable x-ray device FDR Xair XD2000: Fujifilm India

Fujifilm India Private Limited announced Fujifilm’s first portable X-ray device FDR Xair XD2000 that can easily be used with limited space and resources, providing quick and easy access to di


Launch of QIAcube Connect MDx platform: QIAGEN

QIAGEN declared the global launch of the QIAcube Connect MDx, a platform for automated sample processing available to molecular diagnostic laboratories in the US and Canada, the European Union, and


Launch of Covid-19 testing and vaccine management suite: TCS

Tata Consultancy Services (TCS) declared the launch of the Covid-19 vaccine management and testing suite.

This suite of modular, easy-to-deploy solutions simplifies every stage of the


Launch of contactless remote patient monitoring solution for hospitals: Dozee

Dozee declared the launch of Dozee Pro, a Contactless Vitals Monitor for hospitals. The device features an AI-powered triaging system that converts any bed into a step-down ICU in under 2 minutes.


US FDA Emergency Use Authorization to Eurofins EmpowerDX Covid-19 Home Collection Kit


Eurofins’s Clinical Enterprise announced the grant of US FDA Emergency Use Authorization (EUA) for its EmpowerDX Covid-19 Home Collection Kit, a direct-to-consumer (DTC) versio


Better tissue restoration outcomes for breast cancer and other diseases: New technology


New technology from Purdue University innovators may improve tissue restoration outcomes for people with breast cancer and other diseases or traumatic injuries.

Purdue resear


Launch of FDR Nano, digital radiology system: Fujifilm India


Fujifilm India Private Limited declared the launch of its mobile digital radiology system – FDR Nano. This new digital radiology technology with high-resolution imaging with lo


Qiagen and INOVIO expand partnership into developing liquid biopsy diagnosis on NGS technology to treat cervical dysplasia


Qiagen, a Netherlands-based holding company, and INOVIO Pharmaceuticals, a biotechnology company, declared an extension of their collaboration with a new master partnering agreement


US FDA approves nasopharyngeal specimen collection swabs RT-PCR test kit: MJ Biotech's


MJ Biotech declared US Food and Drug Administration (FDA) approval of Sterile and individually wrapped nasopharyngeal (NP) specimen collection swabs for the RT-PCR Covid test. This C


BioIQ collaborates with Assurance Scientific for in-home Covid-19 test kits.


BioIQ and Assurance Scientific Laboratories have partnered to bring over-the-counter (OTC) RT-PCR Covid-19 testing kits in the market.

They have received the US Food and Drug


Medtronic issued a global recall of unused Valiant Navion thoracic stent graft systems


A safety issue has induced Medtronic to issue a global recall of unused Valiant Navion thoracic stent graft systems during a worldwide clinical trial. For the sake of patient safety,


Symbicort Turbuhaler receives China NMPA approval as an anti-inflammatory reliever in mild asthma: AstraZeneca


AstraZeneca declared that its Symbicort Turbuhaler (budesonide/formoterol 160/4.5mcg) is approved in China as an anti-inflammatory reliever to be used as needed in response to sympto


Panbio Covid-19 Ag rapid test device granted CE Mark for asymptomatic screening and self-administered sample collection with nasal swab: Abbott


Abbott declared that it had received CE Mark for two new uses of its Panbio Covid-19 Ag Rapid Test Device to detect the SARS-CoV-2 virus: self-swabbing and asymptomatic testing.


Renewed partnership to deliver hematology testing solutions: Roche and Sysmex


Roche declared that it entered into a Global Business Partnership Agreement (GBP) with Sysmex. Under this, the parties renewed their commitment to the extended-standing distribution,


ADLINK Technology introduces a new range of surgical monitors


ADLINK Technology launched the ASM (ADLINK Surgical Monitor) series of surgical monitors developed for integration with microscopic, fluoroscopic, endoscopic, multi-mo


Launch of "Game-changing," 24/7 automated Blood Pressure monitoring system


Aktiia announced a 24/7 automated blood pressure monitoring system in the UK after receiving CE Mark as a Class IIa medical device. It can record blood pressure data throughout the d


Chondro3 receives US FDA breakthrough device designation: Locate Bio


Locate Bio declared that the U


Launch of Assay to detect a patient's COVID-19 antibody levels


Beckman Coulter, a clinical diagnostics firm, launched its Access SARS-CoV-2 IgG II assay in the CE mark accepting countries. The new assay quantitatively measures a patient's antibo


Elecsys Anti-SARS-CoV-2 S test against SARS-CoV-2: Roche Diagnostics


Roche Diagnostics India declared the launch of its antibody test SARS-CoV-2 test - Elecsys Anti-SARS-CoV-2 S.

The test is CE IVD approved and has received ICMR and CDSCO appr


OraSure’sOrageneDx saliva collection kit included in industry’s first US FDA authorization for whole-exome sequencing platform


OraSure Technologies declared that its OrageneDx (OGD-610) saliva collection device was incorporated as a component in the De Novo authorization granted by the US FDA for a whole-exo


Boston Scientific's Vercise Genus deep brain stimulation system receives FDA approval


The FDA approved Boston Scientific's Vercise Genus deep brain stimulation (DBS) system portfolio for conditional use in a magnetic resonance imaging (MRI) environment. It comprises o


Lightpoint Medical receives CE mark approval for its Robotic gamma probe for intra-operative cancer detection


Medical device company Lightpoint Medical's Robotic gamma probe for intra-operative cancer detection received CE mark approval. The miniaturized surgical tool named SENSEI is designe


VaxArray Measles & Rubella antigen quantification kit: InDevR


InDevR, a life science tools company, announced its VaxArray Measles and Rubella (MR) antigen quantification kit's commercial availability.

The Bill and Melinda Gates Foundat


MHRA approves CoverScan MD, Imaging service for Long-COVID-19


The (MHRA) Medicines & Healthcare products Regulatory Agency of UK approved Perspectum's CoverScan MD, an MRI-based technology to map the effects of COVID-19 on several of the bo


MLC-AL & MLC-KL(medical panel computers): ADLINK Technology


ADLINK Technology Inc. has launched the MLC-AL and MLC-KL series of medical panel computers specifically developed for integrated system control and complex medical data management.


SCTIMST enters technology transfer agreement with Biorad Medisys for intracranial flow diverter stent


SCTIMST signed technology transfer agreements with the Pune-based Biorad Medisys for two biomedical implants, an intracranial flow diverter stent and an atrial septal defect occ


MyHealthcare and AliveCor join hands for home-based ECG monitor, KardiaMobile 6L


MyHealthcare and AliveCor announced their partnership for their KardiaMobile 6L device that allows patients to read their ECG data at home. The collaboration brings an integrated car


Merck and Philips partnership to develop clinical-grade digital solutions for personalized fertility treatment


Royal Philips declared a multi-year partnership with Merck to develop clinical-grade digital solutions for highly customized fertility treatment. These solutions aim to better inform


Launch of digital health app: Abbott


Abbott's neuromodulation portfolio is around Proclaim XR, a version of a St. Jude Medical spinal cord stimulation (SCS) device approved by the FDA in 2015, and the Proclaim DRG Syste


Market release of SCS systems: Boston Scientific


Boston Scientific has enlarged its SCS portfolio with the limited market release of its WaveWriter Alpha SCS (Spinal Cord Stimulator) Systems. The port


Rehabilitation tech tie-up: maxon and Fourier Intelligence


Technology has a vital role in rehabilitation services and healthcare. The partners specialize in exoskeletons and robotic rehabilitation. The two companies are amalgamating their ex


US FDA awards 501(k) marketing clearance to Paragon 28’s R3ACT Stabilization System

Paragon 28, Inc. announced 501(k) marketing clearance from the US Food and Drug Administration (FDA) for its R3ACT Stabilization System. After its commercial launch in


Grants 510(k) clearance to Accuray'sClearRT Helical kVCTImaging for Radixact treatment delivery system: US FDA


Accuray Incorporated declared about grant of 510(k) clearance from the US Food and Drug Administration (FDA) for its ClearRT Helical kVCTImaging for the Radixact System, the latest T


Seeks marketing approval for COVI-STIX rapid detection test of SARS-CoV-2 viral antigen: Sorrento Therapeutics San Diego


Sorrento Therapeutics declared that its agents in Mexico had submitted a Marketing Authorization Application to Mexico's health regulatory authority for its COVI-STIX rapid diagnosti


Micro-Tech Endoscopy and Interscope ink partnership to distribute EndoRotor System for interventional gastroenterology


Micro-Tech Endoscopy and Interscope Inc signed a partnership agreement to collaborate and distribute the EndoRotor System for interventional gastroenterology. 

It is a s


Fitgo launches a range of infrared thermometers with the latest technology


Fitgo has come up with a range of infrared thermometers with the latest technology that may be launched worldwide. The new devices have advanced sensor technology that gives results


Medtronic launches The Tri-Staple EEA™ Circular Stapler In India


Medtronic India launched EEA™ Circular Stapler with Tri-Staple™ Technology. It is touted as the first 3-row Circular Stapler with varied height staples causing lesser str


Health Canada approves Micra AV pacemaker from Medtronic


Health Canada granted its approval to Medtronic Canada's Micra AV pacemaker with atrioventricular synchrony. The USFDA approved the device in January 2020. 

The leadless


Rapid Medical’s steerable neurovascular guidewire gets FDA clearance


The USFDA granted clearance to Rapid Medical’s Drivewire; the guidewire used to treat vascular diseases.

The Israel-based company aims to help treating doctors control


The error rate of pulse oximeters reportedly increases in Black patients


According to a study shared with the New England Journal of Medicine, pulse oximeters have a higher error rate with Black patients. The study states that the handy devices may give m


FDA grants EUA to Quidel's instrument-free COVID-19 antigen test


Quidel's instrument-free COVID-19 antigen test received FDA's emergency use authorization (EUA). It is a pregnancy test-style product that can deliver results in minutes.



Implant meant to fix ACL tears gets FDA De Novo


FDA has approved a resorbable implant under the De Novo premarket review pathway that can fill the crack between the torn ends of a person's anterior cruciate ligament (ACL). It is o


Penumbra recalls catheter device: FDA's request


The catheter device, Jet 7 Xtra Flex, of Penumbra is recalled because of the injury risk and even death during removing clots in stroke patients, after FDA advice. The company announ


Launch of Elecsys SARS-CoV-2 antigen test to detect COVID-19: Roche


Roche declared the launch of the high-throughput SARS-CoV-2 antigen test to aid in diagnosing SARS-CoV-2 infections (Severe Acute Respiratory Syndrome Coronavirus 2) with the CE Mark


Co-WIN mobile app for COVID-19 vaccine delivery


The Central government has launched a new digital platform called Co-WIN for COVID-19 vaccine delivery. There will be a new mobile app and will allow people vaccine registration.


HealthiumMedtech launches Surestitch, a meniscal repair device


HealthiumMedtech has come up with the first 'Made in India' meniscal repair device. The device named 'Surestitch' is a part of its arthroscopy range Sironix. The company has applied


Carpediem cardio-renal pediatric dialysis emergency machine: Medtronic, US


Medtronic plc declared the commercial launch of the Carpediem cardio-renal pediatric dialysis emergency device. After the US FDA marketing authorization grant earlier this year, the


CE mark approval to Advaite’s RapCov rapid antibody test for COVID-19


Advaite, an innovative biotechnology company, declared that it had obtained CE Mark approval for its rapid IgG antibody test called RapCov, which will help contain the spread of coro


Launch of QuantiFERON SARS-CoV-2 RUO solution to detect T-cell response: QIAGEN


QIAGEN declared the launch of its QuantiFERON SARS-CoV-2 Research Use Only (RUO) solution to detect T-cell responses of the immune system to the COVID-19 causing pathogen in humans,


Omron presents a new wheeze detection device


Omron Healthcare has come up with an automatic wheeze detection device, WheezeScan. It is primarily meant for domestic use and detects the presence of a wheeze in young children.&nbs


New COVID-19 testing technique developed by CCMB scientists


The scientists from CCMB (Centre for Cellular and Molecular Biology), Hyderabad, have designed an innovative and most effective COVID-19 testing technique utilizing dry swabs, which


MEQU launches a new and improved battery for blood and IV warming devices


MEQU, a Danish Medtech company, announced a new battery for M Warmer System, the compact blood and IV fluid warming device. Appropriately brand named Power Pack, the new battery has


CDSCO approves Three GOQii Wearables as Medical Device.


the Central Drugs Standard Control Organization (CDSCO) approved three wearable devices from GOQii for medical device registration.

The devices Smart Vital, Vital 3.0, and Vi


FDA approval to Baxter's Home Peritoneal Dialysis System


Baxter has received FDA approval for Homechoice Claria with the Sharesource Connectivity platform for adult and pediatric populations.

The technology is a home peritoneal dia


New AI-Powered Test in IVF Patients: Better Predicts Ongoing Pregnancy and Live Birth Rates


CooperSurgical’s PGTai 2.0 technology is a machine learning AI, with statistical analysis, omitting human subjectivity from the procedure. The technique works by testing embryo


EUA to cPass SARS-CoV-2 neutralization antibody detection kit of GenScript: USFDA


GenScript USA Inc. declared that the USFDA had issued Emergency Use Authorization (EUA) for the cPass SARS-CoV-2 Neutralization Antibody Detection Kit. This kit is the first commerci


EUA to cPass SARS-CoV-2 neutralization antibody detection kit of GenScript: USFDA


GenScript USA Inc. declared that the USFDA had issued Emergency Use Authorization (EUA) for the cPass SARS-CoV-2 Neutralization Antibody Detection Kit. This kit is the first commerci


Launch of new brand FitGo: Smart Tech Overseas


Smart Tech Overseas declared a new brand launch, FitGo, to nurture a healthy routine of life worldwide with its modern medical innovations.

FitGo's first few products in the


Launch of New PHST for catheter-based procedures


Junkosha launched its latest innovation, cut-to-length and slit Peelable Heat Shrink Tubing (PHST), to enable a range of catheter-based procedures where flexibility is the fundamenta


Launch of antibody test with 99.9% specificity: Beckman Coulter


Beckman Coulter has launched its Access SARS-CoV-2 Immunoglobulin M (IgM) assay in CE mark accepting countries. 

The new antibody test demonstrated 99.9% specificity wit


Developed affordable high-end ventilators: Nocca Robotics


Nocca Robotics, is developing economical high-end ventilators

The company is also working on regulatory aspects to export the Noccarc H210 machines and is on track to deploy


Affordable high-end ventilators: Nocca Robotics


Nocca Robotics is developing economical high-end ventilators.The company is also operating on regulatory aspects for Noccarc H210 machines export and is ready to install 400 high flo


Inito Fertility Monitor receives USFDA approval


Bengaluru-based medical technology startup Inito's Fertility Monitor had received the United States Food and Drug Administration approval, resulting in the product's launch in the US


Biodegradable Patch to Monitor Glucose


Anna University researchers have developed a biodegradable material, a cellulose derivative-based polymer, for detecting glucose and alcohol levels from sweat to reduce medical waste


Covid Test Kit Based On RT-LAMP Technology: Agappe Diagnostics


Kochi-based medical devices manufacturer, Agappe Diagnostics Ltd, is launching a new Covid-19 test kit on November 10, based on Reverse Transcription Loop-mediated Isothermal Amplifi


PerkinElmer New Coronavirus Nucleic Acid Detection Kit granted Emergency use authorization: US FDA


PerkinElmer, Inc. declared that the US Food and Drug Administration (FDA) had granted Emergency Use Authorization (EUA), which allows sample pooling with PerkinElmer New Coronavirus


CRISPR-based SARS CoV-2 diagnostic test: Merck collaboration with Mammoth Biosciences


Merck declared collaboration with Mammoth Biosciences for the development, scale-up and commercial production of Mammoth’s CRISPR-based SARS CoV-2 diagnostic test.



Triboelectricity based India's first face mask-3bO


Camellia Clothing, a clothing company based in Bangalore, under an exclusive global license from CeNS, has manufactured and is marketing a 3bO face mask. This is India’s first


Genbody antigen test kits: ICMR approval


Global Diagnostic firm Genbody Inc has received the Indian Council of Medical Research and Drugs Controller General of India's approval for "Genbody Covid-19 AG" antigen test kits to


Cipla collaborates with KARWA Ltd. to launch Covid-19 antibody detection kits in India


Cipla and KARWA Ltd. have collaborated to launch Covid-19 antibody detection kits in India with the brand name ‘ELIFast.’ KARWA ltd. will be responsible for manufacturing


Development of powered air-purifying respirators for health workers: SCTIMST


The Sree Chitra Tirunal Institute for Medical Science and Technology (SCTIMST), a Thiruvananthapuram-based Centre of Excellence under the Department of Science and Technology (DST),


USFDA grants emergency use authorization to South Korea’s Celltrion's Covid test


US Food & Drug Administration (FDA) has approved Celltrion Inc.’s rapid Covid-19 testing kit, Sampinute, for emergency use authorization (EUA). The company initiated the re


West Pharma launches Vial2Bag Advanced 20mm Admixture Device after US FDA clearance


US Food & Drug Administration (FDA) granted 510(k) clearance to the Vial2Bag Advanced 20mm Admixture Device from West Pharmaceutical Services Inc. The company has announced its l


Bayer's FoundationOneCDx as companion diagnostic for Vitrakvi to aid in identifying NTRK fusion-positive patients: US FDA approval


Bayer's FoundationOneCDx for use as the first companion diagnostic gets US FDA approval for identifying neurotrophic receptor tyrosine kinase (NTRK) gene fusion-positive patients whe


ICMR formally announces the approval to use Feluda Paper Strip Test for COVID-19


The Indian Council of Medical Research (ICMR) issued an advisory related to the use of the Feluda paper strip test, by the laboratories, for diagnosis of SARS-CoV-2. The test based o


Researchers come up with a new tool to diagnose stroke using a smartphone


Scientists have come up with a novel tool to assist physicians and speed up stroke diagnosis in clinical settings. The new tool based on machine learning may help diagnose stroke and


Tyber Medical's foot and ankle plating systems: USFDA 510(k) clearance


Tyber Medical LLC, a leading orthopedic device manufacturer, received a US Food and Drug Administration (FDA) 510(k) clearance for foot and ankle plating systems. It covers over 42 d


Steripath Micro Initial Specimen Diversion Device: Magnolia Medical


Magnolia Medical Technologies Inc, a medical device company, launched the new Steripath Micro Initial Specimen Diversion Device.

Micro is the first US FDA 510(k)-cleared devi


Novel mitral valve repair technology may come up from Medtronic and Foundry collaboration


The global medical technology company, Medtronic, collaborated with a medical device company incubator, The Foundry, to bring up a novel transcatheter mitral repair technology (TMVr)


Rapid diagnosis of Sickle Cell Disease may now be possible using a new Ultrasound device


The University of Colorado researchers have come up with a novel test based on ultrasound technology to detect sickle cell disease. The miniature size of the device, its swift mechan


Abbott Healthcare brings its Heart Rhythm Management Devices ICD, CRT-D to India


Abbott Healthcare introduced its new heart rhythm management devices, Implantable Cardioverter Defibrillator (ICD) and Cardiac Resynchronisation Therapy Defibrillator (CRT-D) in Indi


FDA issues final guidelines containing biocompatibility draft on Nitinol devices


After reviewing feedback from its advisory committees, AdvaMed and Cook Medical, FDA has concluded the guidelines pertaining to nonclinical assessment of medical devices containing N


Tiny Robots designed for targeted drug delivery to Colon and Tissue sampling


Researchers at Purdue University have devised externally controlled tiny robots to precisely deliver the drugs at the targeted area. An external magnetic field is used to control the


Semi-Autonomous Colonoscopy using a Robotic Probe is now possible


The University of Leeds researchers have come up with a robotic system to help physicians or nurses perform colonoscopies. It uses magnets for guiding the probe through the body. As


ZEUS ELISA SARS-CoV-2 IgG test system gets EUA approval from USFDA


US Food and Drug Administration (US FDA) granted Emergency Use Authorization (EUA) to ZEUS Scientific's ELISA diagnostic test. The test is used to detect IgG antibodies to the SARS-C


Azure pacemaker with BlueSync technology launched by Medtronic


Medtronic plc's Indian subsidiary India Medtronic Private Limited, launched the Azure pacemaker with BlueSync technology. It is designed to communicate seamlessly with patient's smar


Launch of Pressurized Metered Dose Inhaler in India for COPD Patients: Zydus Cadila


Zydus Cadila launched India's first pressurized Metered Dose Inhaler (pMDI), ForglynpMDI, for Chronic Obstructive Pulmonary Disease (COPD) patients in India. With a price tag of Rs.


SyntheticMR to integrate SyMRI in GE Healthcare's platform


SyntheticMR has collaborated with GE Healthcare to merge its MRI solution SyMRI in GE's platform. The newly integrated platform may provide quicker workflows and complete physiologic


WaveWriter Alpha SCS from Boston Scientific will now be available in Europe


Almost the entire range of WaveWriter Alpha Spinal Cord Stimulator (SCS) Systems was officially launched in Europe by Boston Scientific, a global medi-tech giant. It includes four MR


Japan PMDA approved Itamar Medical’s WatchPAT 300 home sleep apnea testing device


Japan's Pharmaceuticals and Medical Devices Agency (PMDA) approved the Itamar Medical's WatchPAT 300 Home Sleep Apnea Testing (HSAT) device for commercial launch, effective September


ICMR approves Biocard Pro COVID-19 Antigen Rapid Testing Kits from Trivitron


Trivitron Healthcare Private Limited received approval from the Indian Council of Medical Research (ICMR) to launch its 'Biocard Pro COVID-19 Rapid Antigen' testing kits commercially


CardioQuip's heater-cooler device could cause infection, warns FDA.


FDA issued a notice warning the healthcare providers about the risk of infection through using CardioQuip’s heater-cooler device. The device is used to control patients' body t


Abbott's latest CGM device, Libre 3, receives CE mark


FreeStyle Libre 3, the latest continuous glucose monitoring (CGM) device from Abbott, received the CE mark, thereby paving the way for its commercial launch in the European market. A


Equine Biotech, an IISc start-up, comes up with a Pocket-Friendly RT-PCR kit


Equine Biotech, a start-up of IISc (Indian Institute of Science) students, has developed a novel and affordable Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) diagnostic ki


University of Illinois partners with Aequs to bring up mechanical resuscitator


Aequs Force Consumer Products Pvt. Ltd. is coming up with a medical-grade and affordable mechanical resuscitator, AQovent. The company, in collaboration with the University of Illino


SeaSpine launches WaveForm C 3D-printed interbody implant system


WaveForm C Interbody Implant System was launched commercially by SeaSpine. The global medical technology giant plans to launch four more devices by mid-2021.

The novel WaveFo


KardiaMobile 6L, clinically-authenticated exclusive ECG device launched in India by AliveCor


KardiaMobile 6L, the best personal electrocardiogram (ECG) device with US FDA approved ECG technology, was launched by AliveCor in India. It has proven efficacy in detecting atrial f


Vela Diagnostic: ViroKey SARS-CoV-2 RT-PCR test v2.0 gets US FDA approval for emergent situations


The US Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) to ViroKey SARS-CoV-2 RT-PCR Test v2.0 of Vela Diagnostics. Certain laboratories certified und


RTI Surgical's DAC Plate gets USFDA approval under section 510(k)


USFDA granted 510(k) clearance to the RTI Surgical’s Dynamic Active Compression (DAC) plate. Post-approval, the DAC plate has become the first-ever product that may be used to


Wipro’s Chitra Air Bridge to be available for breathing assistance anywhere with Wipro 3D and GenWorks partnership


Affordable breathing assistance medical device, Chitra Air Bridge, may become available for all as Wipro 3D ties up with GenWorks Health.

As the COVID-19 cases are surging in


MedSpark- The first Medical Device Park in India


Kerala - First state of India to possess the first Medical Device Park in the country. Recently, the foundation stone of the MedSpark Medical Device Park was laid by the honorab


Tata group forays into Medical Diagnostics as DGCI approves its economical Covid-19 Test Feluda


The Drug Controller General of India (DCGI) approved the commercial launch of the low-cost COVID-19 test, FELUDA, under strict ICMR guidelines. The test designed by CSIR (Council of


Aesthetic medical devices' launch, NuEra Tight with FocalRF for personalized body sculpting treatments: Lumenis


The largest energy-based medical device company, Lumenis Ltd., announces the launch of revolutionary NuEra Tight with FocalRF technology, in the Middle East and Europe for body sculp


Non-invasive medical instruments for pain relief in India : OSKA India


OSKA Wellness launched 'OSKA Pulse'; PEMF (Pulsed-Electromagnetic-Field-Therapy) technology-enabled products, in India.

The company is the first enabler of this innovative te


Roche's Cobas 6800/8800 HIV-1/HIV-2 Qualitative Test for HIV/AIDS detection: US FDA approval


US Food and Drug Administration (FDA) approval awarded to Roche for the cobas 6800/8800 HIV-1/HIV-2 Qualitative Test in the US. The healthcare professionals may have a single result


Foundation One Liquid CDx (a comprehensive pan-tumor liquid biopsy test): US FDA approval


Roche received US Food and Drug Administration (FDA) approval for Foundation One Liquid CDx, Foundation Medicine’s comprehensive pan-tumor liquid biopsy test for solid tumor pa


Release of draft guidance on PROs for device manufacturers: FDA


The US Food and Drug Administration (FDA) released a new draft guidance for Device manufacturers for the selection of patient-reported outcome (PROs) instruments in clinical&nbs


Guidelines to conduct COVID-19 screening in TB patients: Health ministry


The Union health ministry releases guidelines stating that tuberculosis (TB) screening will be done for all COVID-19 positive patients and COVID-19 screening will be done for all TB


New workflow and imaging enhancements for Kodex-EPD cardiac mapping and imaging system for heart rhythm disorders: Philips


Royal Philips announces new imaging and workflow enhancements for its novel Kodex-EPD cardiac imaging and mapping system. The system treating a common heart rhythm disorder,&nbs


Launch of High-Flow Oxygen Therapy Device, Noccarc H210 for critical COVID-19 patients: Nocca Robotics


Nocca Robotics Pvt Ltd, of SIIC, IIT Kanpur, launched a clinically validated and certified High- Flow Oxygen Therapy Device for COVID-19 patients. The device is high-quality critical


Abbott Rapid Covid-19 Test Kit For Emergency Use: USFDA Nod


Abbott receives Emergency Use Authorization (EUA) for its BinaxNOW COVID-19 Ag Card rapid test for COVID-19 infection detection from the U.S. Food and Drug Administration (


Ban Lifted on export of PPE medical coveralls & 2/3 ply surgical masks: DGFT


The Directorate General of Foreign Trade (DGFT) lifts ban on PPE medical coveralls and all masks export varieties, except N95 masks.

DGFT, on August 25, 2020, revised the exp


FDA approves Foundation Medicine's pan-tumor biopsy test


The US Food and Drug Administration (FDA) approves Foundation Medicine's pan-tumor liquid
biopsy test FoundationOne Liquid CDx.

The kit's assay uses blood samples to e


India’s first-ever rapid diagnostic test kit for Covid-19 gets ICMR approval


Delhi based Oscar Medicare Pvt. Ltd. that manufactures various in-vitro diagnostic kits have developed a simple, single prick rapid testing kit for detecting COVID


FDA Clearance to Home use Intravaginal Device For Stress Urinary Incontinence (SUI)


The U.S. Food and Drug Administration (FDA) has issued clearance for Flyte™, intravaginal in-home, non-invasive, device meant to strengthen the pelvic floor muscles, which help


High-flow nasal oxygen (HFNO) method seems to be crucial during COVID

HFNO has become synonymous with a bridge between mask and ventilator. It is replacing the invasive mechanical ventilation for treatment of respiratory distre


Leven Medical: India-Dutch collaborative startup announces smart ventilators with AI ML


The smart ventilators can auto adjust patient's oxygen flow. In emergent cases, these send alerts to the concerned medical staff and to family members. The startup claims that the ve


Smart wearable devices may detect COVID-19 even before the symptoms: Fitbit


Fitbit, a leading manufacturer and marketer of health-tracking watches, launched a study aiming to create an algorithm to detect COVID-19 before symptoms appeared. Out of the 100,000


Phillips-Medisize launched the Aria Smart Autoinjector platform that unlocks innovation, differentiation, and sustainability in the digital drug delivery device market

Phillips-Medisize unveiled a compact and better-looking disposable autoinjector named "Aria Smart Autoinjector." The autoinjector has sound and light signals to indicate dose progress and completio


USFDA grants CINtec PLUS Cytology test of Roche for screening of cervical cancer


Roche was awarded by US Food and Drug Administration (FDA) grant for CINtec PLUS Cytology for the 1st biomarker-based triage test for women whose primary cervical cancer sc


Warning of Cancer can be done by Blood test for microbial DNA


A new study advertised in the journal Nature on March 11, 2020, could change the currently held aspects on cancer causation and diagnosis. The researchers have come up with


Genetic test could assist doctors in identification of patients with ultra-high risk multiple myeloma


A novel genetic test could assist doctors in picking out patients with the bone marrow cancer multiple myeloma that is at 'ultra-high risk' of their cancer progressing aggr


XCR Diagnostics receives US patent for technology that expedites testing and recognition of infectious diseases


A molecular diagnostics company known as XCR Diagnostics has been granted a patent by the United States Patent and Trademark Office (US PTO) for its technology that expedit


Silfradent Srl received warning letter


An inspection has been performed at firm located in Santa Sofia, Forli-Cesena, Italy, on July 29, 2019 to August 1, 2019, an investigator from the United States Food and Dr


Regulation of Medical device in Japan and India discussed at 4th India-Japan Medical Products Regulatory Symposium


Regulatory and Clinical trial supports for innovative drug development in Japan, latest upbeat of clinical trial needs in pre and post marketing phase in India, and medical


Newly created mobile app aids in reduction of pain in osteoarthritis patients


By conducting a few simple physical exercises routinely, and getting data about their disease regularly, 500 osteoarthritis patients were able to on average halve their pai


Excillum introduces the NanoTube N2 - the X-ray resolution revolution continues with higher voltage and more power


Excillum which is Stockholm-based Company declared the introduction of a new generation high-resolution X-ray tubes.

The Excillum NanoTube N2 110 kV and N


Bio-ADM of Sphingotec can reliably assist physicians in recognizing high-risk sepsis patients


Diagnostics company SphingoTec GmbH announced on new information on the utility of endothelial function biomarker bioactive Adrenomedullin (bio-ADM®). The data demonstr


SCTIMST creates intracranial flow diverter stent for treatment of aneurysms of blood vessels of brain


The Sree Chitra Tirunal Institute for Medical Sciences and Technology (SCTIMST), Thiruvananthapuram, which is an institute of national importance, has created an innovative intr


CryoLife receives CE Mark for E-vita Open NEO hybrid stent graft


A leading cardiac and vascular surgery company known as CryoLife, Inc., committed on aortic disease, declared that it has achieved CE Mark for the E-vita Open NEO, a hybrid sten


Recalling of Alaris System Infusion Pumps by Becton Dickinson (BD) CareFusion 303 Inc.


The Alaris System is vital signs monitoring system and an infusion pump. The infusion pumps deliver medications, fluids, blood and blood products into the body of a patient


Novel AI system can access endoscopic observations of ulcerative colitis with accuracy


Evaluations of patients with ulcerative colitis (UC), which is a kind of inflammatory bowel disease, are usually performed via histology and endoscopy. But now, researchers


Draft Medical Devices Bill for stakeholders review soon will be circulated by Niti Aayog


To talk about the regulatory vacuum and issues of patient safety in medical devices, Niti Aayog is likely to spread a draft of the Medical Devices Bill for stakeholders review to fra


Merck introduces LANEXO system to increase productivity of scientists in laboratory


A leading science and technology company, Merck, inaugurate its LANEXO Lab Inventory, safety and compliance management system which is a new digital laboratory informatics solut


Elecsys GALAD score of Roche gains US FDA breakthrough device designation to diagnose HCC


Roche declared that the US Food and Drug Administration (FDA) has approved Breakthrough Device Designation to the Elecsys GALAD score. This algorithmic score cumulates gender and age


SCTIMST creates device for non-surgical closure of atrial septal defect in heart


An institute of national importance, the Sree Chitra Tirunal Institute for Medical Sciences and Technology (SCTIMST), Thiruvananthapuram, has created a nickel-titanium allo


An App was developed by researchers for Predicting Risk of Preterm Birth


An enhanced mobile phone app will aid in identifying women who require special treatments at the right time and lower the emotional and financial burden on families and the


Avanos receives FDA clearance for COOLIEF Radiofrequency system


Avanos Medical has gained clearance from the US Food and Drug Administration (FDA) for selling its 80W COOLIEF Radiofrequency (RF) system for neurological lesion procedures


Cynosure gained FDA clearance for RF micro-needling device


A US-based medical device company known as Cynosure is committed on medical aesthetics, has gained regulatory clearance from the US Food and Drug Administration (FDA) for i


FDA grants heart and lung support system of Novalung


The US Food and Drug Administration (FDA) has granted Novalung, a heart and lung support system created by Fresenius Medical Care North America (FMCNA) to treat acute respi


For Critically-ill Patients, FDA grants Heart and Lung Support System


Novalung® has been cleared by the U.S. Food and Drug Administration (FDA) which is a heart and lung support system to treat acute respiratory or cardiopulmonary failure


FDA approves breakthrough status to RESPMETER device of Altair Medical


RESPMETER wearable biosensor device of Altair Medical has been granted Breakthrough Device status by the US Food and Drug Administration (FDA) in an effort to manage the gl


FDA awards marketing authorization for Fragile X Syndrome test


The US Food and Drug Administration (FDA) has awarded marketing authorization to Asuragen for its AmplideX Fragile X Dx and Carrier Screen Kit to assist in identifying Frag


First Genetic Test for Diagnosing Fragile X Syndrome granted by FDA


The U.S. Food and Drug Administration today granted marketing of the first test for the detection of a genetic condition known as Fragile X Syndrome (FXS), the most common known


New Device engineered for treatment of Intracranial Aneurysms achieved CE Mark Approval


A new device to treat of intracranial aneurysms, Contour Neurovascular System has achieved European CE Mark approval, declared medical device company Cerus Endovascular. Th


As per the Ministry of Chemical and Fertilizers, Violation of Price Capping of Coronary Stent has been done to Attract NPPA Action


The Ministry of Chemical and Fertilizers recently announced the Parliament that if any violation of price capping relating to Coronary Stents is found by the National Pharm


As per ICRA, medical devices to be brought under Drugs Act to assist in medical device regulation effectively


ICRA has co


Novacyt, an Anglo-French Company introduces CE-IVD Marked Novel Coronavirus Diagnostics Test


Novacyt, an Anglo-French Company specializes in clinical diagnostics currently declared that its molecular diagnostics division, Primerdesign, has introduced its CE-Mark mo


Continuous Wearable BP & Vital Signs Monitor with ECG Patch


A Wireless Vital Signs Monitor and Continuous Blood Pressure & with ECG Patch has been commercialized for use of patients. This is developed by Caretaker Medical, a lea


FDA grants Eko cardiology technology advancement


Prior this month, Eko, an artificial intelligence (AI) digital health company, was approved FDA approval for its latest cardio-technology.

The US-based co


Prediction of Death Due to Stroke and Heart Attack can be done by AI with Cardiac MRI


University College London Researchers have utilized artificial intelligence for the first time to instantly and precisely measure blood flow. Utilization of Artificial inte


Health ministry furnishes notification to maintain all medical devices under D&C Act from April 1, 2020


Union health ministry has announced that all medical devices will now be maintained under the Drugs and Cosmetics (D&C) Act, 1940 with effect from the April 1, 2020 for


FDA approves 510(k) clearance to MRI system of Hyperfine Research


The US Food and Drug Administration (FDA) have approved 510(k) clearance to bedside Magnetic Resonance Imaging (MRI) system of Hyperfine Research.

The fir


Surgical System of TransEnterix’s Senhance receives CE Mark approval


Medical device company TransEnterix has obtained CE Mark approval for an extended indication of the Senhance Surgical System for treatment of paediatric patients weighing a


FDA grants mobile app of Orthofix for bone growth stimulators


Orthofix Medical declared today that it gained FDA approval for its STIM onTrack mobile app version 2.1 for utilization with its bone growth stimulators.


Progression of Parkinson's disease can be predicted by simple Blood test


Researchers have observed that a blood test for cell senescence biomarkers and inflammatory may be a reliable predictor of cognitive decline, involving identifying those wh


FDA approves Surfacer System De Novo clearance of Bluegrass Vascular


The US Food and Drug Administration (FDA) have approved a De Novo clearance to Surfacer Inside-Out Access Catheter System engineered by private medical technology company B


Medical devices to be maintained as drugs


All medical devices marketed in the country will now be maintained as ‘drugs’, and come under the purview of the Drugs and Cosmetics Act. The government stated


Bringing MRI to Bedside in Stroke Patients using portable MRI


At current scenario patients have to move to a location of a high-field MRI device for diagnosis of stroke causing vital delay in diagnosis. However, Advancement in low-fie


icometrix gains FDA approval for icobrain ep solution


icometrix has gained 510(k) clearance from the US Food and Drug Administration (FDA) for its icobrain ep solution.

Icobrain ep assists in identification o


First medical device for usage in U.S by SA biotech cleared by FDA


Bluegrass Vascular Technologies has gained regulatory approval from the Federal Drug Administration to provide its medical device on the market in the U.S. roughly 9 years


Marketing approval obtained by cardiac ultrasound software of Caption Health


Caption Health has gained authorization from the US Food and Drug Administration (FDA) for marketing its cardiac ultrasound software.

Caption Guidance, th


FDA provides OTC clearance to INNOVO of Atlantic Therapeutics for SUI


The US Food and Drug Administration (FDA) have provided over-the-counter (OTC) clearance to INNOVO of Atlantic Therapeutics, a non-invasive and wearable device for stress u


FDA breakthrough designation received by Aria CV for Its medical device to treat pulmonary arterial hypertension


A developer of medical devices, Aria CV, Inc., for treating Pulmonary Arterial Hypertension (PAH), today declared that they have secured from U.S. Food and Drug Administrat


MRI-compatible products by Imricor receives CE mark approval


Vision-MR Ablation Catheter and Vision-MR Dispersive Electrode get CE mark approval to conduct cariac catheter ablations using real-time MRI. Imricor is the first company to have car


FDA 510(k) clearance to BioSticker


The BioSticker™ on-body sensor for scalable remote care by BioIntelliSense Inc. receives the FDA 510(k) clearance.

 A new standard for remote patient monitoring is


AI tool to recognize modifications in patients' mental health


Researchers, involving one of Indian-origin, have created an artificial intelligence (AI) tool that can precisely detect modifications in clinical states in voice data of p


Siemens reveals medical manufacturing centre in Bangalore


Siemens Healthineers which is a medical technology company has initiated its first manufacturing facility in Bengaluru, which will complement its existing R&D centre. T


Novel 'smart' chair aids in correcting body posture from childhood


The concept of the current study is already submitted in the conference materials furnished by the French publishing house Atlantis Press, contented by the Scopus and


Team discovers a way to eliminate GI device without the usage of endoscopy


Scholars at Massachu


Fitness tracker devices demonstrate potential as predictors of flu outbreaks


Scholars at Scripps Research Translational Institute have discovered that fitness tracker devices – wearable tracker devices that calculate heart rate and sleep durat


Pentax Medical receives FDA approval for IMAGINA endoscopy system


A unit of Hoya Group, Pentax Medical, has received 510(k) clearance from the US Food and Drug Administration (FDA) for its IMAGINA endoscopy system.

The endoscopy platform wa


Medtronic gains CE Mark approval for InterStim products


Medtronic which is Irish medical device maker has secured CE Mark approval for its InterStim Micro neurostimulator and InterStim SureScan MRI leads.

By giving full-body MRI s


Clearance of new AI system from FDA for spotting stroke


501(k) clearance has been granted to the US Food and Drug Administration (FDA) for radiology company Aidoc’s AI-based system for the recognition of large-vessel occlusion (LVO)


Phagenesis gains FDA breakthrough green light for Phagenyx System for restoring swallowing


Phagenesis declared that it has secured breakthrough device designation from the FDA for its Phagenyx System for restoring neurological swallowing control.

The Phagenyx Syste


New Guidance advertised on Medical Devices and Cybersecurity


New European medical device guidance will need manufacturers to carefully review IT security and cybersecurity needs in relation to their devices and in their product literature


Breakthrough Therapy Designation filed by CytoDyn with the FDA for the Utilization of Leronlimab to treat Metastatic Triple-Negative Breast Cancer


A late-stage biotechnology company known as CytoDyn Inc. is committed on developing leronlimab (PRO 140), a CCR5 antagonist with the capability for multiple therapeutic ind


Researchers created AI system to locate and grade prostate cancer


Researchers have created a method addressed on artificial intelligence (AI) for diagnosis and grading of prostate cancer.
The AI-system has the capability to solve one of t


URO17 bladder cancer recurrence test of KDx Diagnostics obtains USFDA breakthrough device designation


KDx Diagnostics, a company committed on developing non-invasive cancer tests to enhance early detection and therapy decisions in cancer, declared that the Food and Drug Adm


Silver Bullet achieves CE Mark for antimicrobial bone screw system


Silver Bullet Therapeutics which is US-based medical device company has gained CE Mark approval for the commercial sale of its antimicrobial bone screw system in the European Union (


Reflow receives breakthrough designation for spur stent system


Reflow Medical has obtained breakthrough device designation for its Temporary Spur Stent System from the US Food and Drug Administration (FDA).

The retrievable stent tec


Abbott obtains FDA approval for procedure of heart pump implant


Abbott has gained approval from the US Food and Drug Administration (FDA) for its minimum invasive heart pump implant procedure to assist patients in avoiding open heart surgery


USFDA grant approval to Abbott's HeartMate 3 heart pump to aid patients avoid open heart surgery


Abbott declared that the US Food and Drug Administration (FDA) has granted approval to a new alternative surgical technique for Abbott's HeartMate 3 heart pump that will permit


Cognetivity Neurosciences declares regulatory approval of 1st CE-marked medical device


Cognetivity Neurosciences Ltd. declared that its Integrated Cognitive Assessment (ICA) software has been granted as a CE-marked medical device. The declaration follows Cognetivi


FDA grants 510(k) clearance for handheld OCT scanner of PhotoniCare


510(k) clearance for PhotoniCare’s TOMi Scope has been granted by the US Food and Drug Administration (FDA) for non-invasive imaging of the middle ear to diagnose ear infe


Bioness gains CE Mark approval for StimRouter system


Bioness, a US-based medical technology company has gained CE Mark approval for its StimRouter neuromodulation system for treatment faecal incontinence.

The small implant


FDA grants approval for Control-IQ artificial pancreas system


The U.S. Food and Drug Administration has granted approval for an artificial pancreas system that automatically regulates and monitors blood sugar levels.

The system is addre


MyShoulder placement guides of Medacta cleared by FDA


Medacta obtains FDA clearance for their MyShoulder Placement Guides for shoulder arthroplasty. This patient-compatibility, 3D printed solutions work in co-existence with the Medacta


IIT-Roorkee makes a bioresorbable, economical ortho implants for healing of bone fractures


Scholars and researchers at the Indian Institute of Technology (IIT), Roorkee have made bioresorbable and economical orthopaedic implants to heal bone fractures.

The recent s


Invention of cost-effective bio-resorbable orthopaedic implants by IIT Roorkee for healing bone fractures


Invention of cost-effective bio-resorbable orthopaedic implants for healing bone fractures were done by the researchers of IIT Roorkee. The recent strategies of therapeutic to h


Ultrasound along with MRI enhances prostate treatment


MRI-guided transurethral ultrasound ablation (TULSA) is a novel tool for the highly precise treatment of prostate cancer — without the common side effects. Scans of ultras


First indigenous CT-scanner shipped by Siemens Healthineers from its new Bengaluru facility

Siemens Healthineers has shipped its 1st indigenous CT scanner from its currently launched prior art medical imaging factory in Bengaluru. The Somatom g


For 24 hours health monitoring tiny microsensor implants has been developed


Researchers at National University of Singapore (NUS) have created tiny subcutaneous implants that can continuously quantify a heart rate, blood sugar and other physiological conditi


Implants specific to patients are developed at Central Scientific Instruments Organisation


Jaw and bone implants specific with patients can now be developed and created within the country, inside IARM (innovative additive research and manufacturing) laboratory establi


FDA clearance secured by Life Spine to market Titanium Stand-Alone ALIF Spacer System


FDA 510(K) Clearance secured by Life Spine for the Titanium Stand-Alone ALIF System. It is the 7th product of the company to obtain FDA approval this year.

The Tita


As per 2013 standards Accu-Chek blood glucose monitoring systems are in compliance with latest IS/ISO 15197


Roche Diabetes Care (RDC) India declared that its Accu-Chek brand of blood glucose monitoring products are in compliance with the revised standards of IS/ISO 15197:2013. It has


A preoperative blood test may anticipate risk of cardiac complications after surgery


The number of surgical interventions is on the elevation and together there is an enhancement in number of postoperative complications.

Of all the patients who have undergone


New Software System for Insulin Control was granted by FDA


Tandem Diabetes Care has secured approval in the US for a new software system that can be utilized in “artificial pancreas” systems to automatically measure blood glucose


Recalling of vagus nerve implant by LivaNova amid reset issues


LivaNova is calling back its vagus nerve stimulation (VNS) device that is implanted in patients for treatment of major depressive episodes and to control seizures related with epilep


Prevention of ICU delirium and improvement in patient outcomes led by new developed software


Intensive care unit delirium which is a fertile area of clinical research and patient care innovation related with Vanderbilt University Medical Center, is initiating to reshape how&


Novel genetic test may anticipate ischemic stroke at birth


Major cause of death and permanent disability worldwide is stroke. About 80% of strokes are “ischemic” — meaning, they are caused due to the blockage of an artery t


Novel AI app may prohibit patients from severe falls


A novel machine learning app has been created for prohibiting patients from severe fall-related injuries and deaths. Houston Methodist have created novel AI technology whic


Renewed CE mark gained by IRRAS for IRRAflow catheter


IRRAS received CE mark approval for its IRRAflow catheter. The new approval is gained after the company obtained 2 CE marks for its IRRAflow system’s tube set with a digital pu


Recalling device by LivaNova for treatment of seizures, depression


Recalling of device by LivaNova is done which is London medical device-maker that helps in treatment of adults and children over 4 years old with partial onset seizures that hav


Bristol-Myers Squibb obtains USFDA approval for CAR T cell therapy for treatment of LBCL patients


Bristol-Myers Squibb Company declared the filing of its Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for lisocabtagene maraleucel (liso-cel


EB19-J10U Ultrasound Video Bronchoscope released by PENTAX in United States


PENTAX received the USFDA clearance for its new EB19-J10U endobronchial scope. The device, proposed for minimally invasive procedures such as EBUS-guided Transbronchial Needle A


Testing Clearance in EU for FINDER Device for Bedside G6PD Deficiency


Baebies has secured the CE Mark for its FINDER device, paving the way for Europe introduction. The device can render in identifying Glucose-6- Phosphate Dehydrogenase (G6PD


AiMeD praised proposed medical devices bill by Niti Aayog to consider patient safety


Association of Indian Medical Device Industry (AiMeD) praised proposed medical devices bill by Niti Aayog to consider safety of patient and import dependency issues. Its objecti


FDA breakthrough nod secured for Mayo Clinic which has AI-based heart failure screening from Eko


Eko which is Digital Health Company secured breakthrough device designation from FDA for priority review of the algorithm to detect heart failure of company with a specialized stetho


FDA advises Conformis over sterilization cycle failures


FDA proclaimed regarding a warning letter to Conformis, a Massachusetts-based customized joint implant manufacturer, quoting sterilization issues regarding the knee replacement syste


Breakthrough status granted to Eko’s ECG-based algorithm by FDA


Eko Devices which is a digital health firm has gained breakthrough device designation from the US Food and Drug Administration (FDA) for its ECG-based low ejection fraction screening


Medfusion® 4000 Syringe Pumps Recalled by Smiths Medical ASD, Inc. Due to Malfunctioning Alarms and Potential Interruption of Therapy


The FDA has recognized the recall as a Class I recall which is the most serious type of recall. Utilization of these devices may cause morbidity or mortality.

The Smiths Medi


FDA Clearance obtained by TAP At-Home Blood Collection System


Seventh Sense Biosystems secured FDA clearance for its TAP device to be utilized by laypersons for collection of blood.The device is now given green signal to be utilized at home by


FDA Clearance for Cranial Procedures of Medtronic Stealth Autoguide System


A cranial robotic platform from Medtronic which is the Stealth Autoguide has been given clearance by the FDA. The system renders accurate and partially automatic positioning and adva


AI-driven prostate launched by Anixa Biosciences for cancer detection test


Anixa Biosciences has commercially introduced Cchek Prostate Cancer Confirmation (Cchek PCC) test. The low-cost blood test is considered to accurately identify the existence of cance


CE Mark obtained by Aleva Neurotherapeutics for brain stimulation system


Aleva Neurotherapeutics has obtained CE mark for its directSTIM Deep Brain Stimulation (DBS) system. The DBS system technology permits accurate steering of current towards the desi


AI assisted polyp detector of Pentax Medical, Discovery obtains CE marking


A division of the Hoya Group, Pentax Medical received CE mark for Discovery, an innovative Artificial Intelligence (AI) assisted polyp detector structured to support endoscopists in


OmniBeds and Giraffe Incubators are recalled by GE Healthcare Recalls Due to Potential for Infants to Fall


The FDA has recognized this as a Class I recall which is the most serious type of recall. Utilization of these devices may cause morbidity or mortality. 

Warmers an


CrossCath® Support Catheters recalled by Cook Medical Due to a production Error Which May Cause the Marker Bands to Dislodge or Cause hooking


The FDA has recognized this as a Class I recall which is the most serious type of recall. Utilization of these devices may cause morbidity or mortality.

The CrossCath&re


Zika blood screening test introduced by Roche


Roche has declared the launch of its cobas Zika test to markets that are in compliance with the CE mark. The cobas Zika test, which is proposed for use in screening blood donati


Tandem gains FDA clean chit for 1st interoperable, automated insulin software for dosing


FDA granted the third and final type of diabetes management technology necessary for a wholly inter-operable, automated insulin system for dosing.
The clearance of De Novo went


Boston Scientific receives first US disposable duodenoscope clearance


510(k) clearance was granted by FDA to the 1st ever wholly disposable duodenoscope which is a device developed by Boston Scientific.
Jeff Shuren who is the Health Director of Ce


SynchroMed II Implantable Drug Infusion Pump Recalled by Medtronic


Currently, FDA released a report that Medtronic has recalled its SynchroMed II implantable drug infusion pump, part of the SynchroMed Infusion System, after obtaining reports of


FDA Approves First Disposable Duodenoscope which Reduces Risk of Infection


When duodenoscopes which are utilized for diagnosis of illness in the pancreas and bile ducts are not cleaned properly, can cause hundreds of cases of severe, sometimes fatal, infect


FDA grants tool for evaluating safety of implanted devices


An announcement was done regarding FDA securing a tool which is created to make it simpler for developers of active implantable medical devices (AIMDs) to make safety test results.


SynchroMed II Implantable Drug Infusion Pump Recalled by Medtronic


Due to the potential availability of Foreign Particles Inside the Pump Motor Assembly Which May result in Pump Motor Stall Part of the SynchroMed Infusion System which is known as


FDA approval to Cochlear for conduction of bone implant


Cochlear has obtained clearance from the US Food and Drug Administration (FDA) for its Osia 2 implantable conduction hearing system of bone.
Connection between the Osia OSI200 I


LimaCorporate, TechMah Medical obtain USFDA 510k approval for Smart SPACE Shoulder 3D Planner & 3D Positioner


A global medical device company known as LimaCorporate obtains the FDA 510K approval for Smart SPACE Shoulder 3D Planner & 3D Positioner. Being an innovative digital platform, Sm


Breakthrough designation to Beta Bionics for blood sugar device


Breakthrough device designation status has been obtained by Beta Bionics from the US Food and Drug Administration (FDA) for its iLet Bionic Pancreas System. iLet Bionic Pancreas is a


CE mark received by Roche for blood glucose monitoring app


CE mark has been granted to Roche for its smartphone app that permits users to quantify blood glucose level without the requirement of a meter. This is known as Accu-Chek SugarVie. T


FDA labelled breakthrough device to Beta Bionics' pancreas tech


Boston-based medtech Beta Bionics received FDA Breakthrough Devices Program for its iLet system, which utilizes mathematical algorithms for dosing to automatically control blood suga


FDA scores novel Medtronic SynchroMed II call back as Class I event


As per the reports released by agency, FDA classified a Medtronic voluntary call back of certain SynchroMed II implantable drug infusion pumps as a Class I event.

The recall,


FDA recommends option 510(k) criteria for MRI coils


Issuance of a draft guidance document was done by FDA describing the performance criteria that producers of radio frequency coils for magnetic resonance imaging (MRI) can utilize to


Breakthrough therapy designation received by Bristol-Myers Squibb's ORENCIA from US FDA


Breakthrough Therapy Designation was granted by the US Food and Drug
Administration (FDA) to Bristol-Myers Squibb Company for ORENCIA (abatacept) for the moderate to severe acut


Regulatory Approval to Mainstay Medical from Australian Therapeutic Goods Administration (TGA) for ReActiv8


Mainstay Medical International received regulatory approval from the Australian Therapeutic Goods Administration (TGA) for ReActiv8, its implantable restorative neurostimulation syst


Cobas vivoDx MRSA of Roche Molecular System receives approval from FDA


Marketing approval has been granted by the US Food and Drug Administration (FDA) for cobas vivoDx, MRSA of Roche Molecular System which is a diagnostic test that helps in the detecti


FDA clearance obtained by Sight Diagnostics for Olo blood analyser


Sight Diagnostics  had obtained clearance from the US Food and Drug Administration (FDA) for its Olo blood analyser, which is able to process results for a complete blood test i


BioPrax, Infection-Eradicating was tagged ‘Breakthrough’ by USFDA


“Breakthrough Device” designation has been granted to Garwood Medical Devices, LLC, from the U.S. Food and Drug Administration (FDA) for the BioPrax device of the company


Surgical robot of Vicarious obtains breakthrough status by FDA


Vicarious has managed to secure breakthrough device status from FDA for Surgical's robotic surgical system. The status, is the 1st awarded to a surgical robot, blankets technology st


afib device of Boston Scientific efficient in reduction of stroke


FDA-mandated registries had 2 long-term studies which are associated to Boston Scientific's left atrial appendage closure device known as Watchman, to vital reductions in stroke risk


FDA approval received by HealthLytix for prostate imaging software


510(k) clearance has been granted by the US Food and Drug Administration (FDA) for breakthrough prostate imaging software, RSI-MRI+ of HealthLytix.

The approval holds a


System for the delivery of ear tubes approved by the FDA for local anesthesia to treat ear infection


An approval was granted by the USFDA to a new system for the delivery of tympanostomy tubes, commonly known as ear tubes that can be inserted into the eardrum for treatment of the re


Breakthrough Therapy Designation for MDD received by Psilocybin


Usona Institute, Madison, Wisconsin, was recently granted with the Breakthrough Therapy designation for psilocybin by the US Food and Drug Administration (FDA) for the treatment of p


Renovia obtains FDA approval for Pelvic Digital Therapeutic


510(k) clearance has been granted by the US Food and Drug Administration (FDA) for next- generation leva Pelvic Digital Therapeutic device of Renovia.
The therapeutic device of


Novel treatment for targeting abnormality in sickle cell disease approved by FDA


An accelerated approval was granted by the USFDA to Oxbryta (voxelotor) for the treatment of sickle cell disease (SCD) in adults and pediatric patients 12 years of age and older. The


FDA 510(k) Clearance received by US Medical Innovations for the Canady Plasma Smart XL- 1000 Generator


A Biomedical and Life Science subsidiary of US Patent Innovations, LLC (USPI) known as US Medical Innovations, LLC (USMI), obtained the U.S. Food and Drug Administration (FDA) 510(k)


BRAC Analysis diagnostic system of Myriad Genetics received Japanese nod for breast cancer patients


Japan’s Ministry of Health, Labour and Welfare (MHLW) has given consent to the BRACAnalysis Diagnostic System (i.e., “BRACAnalysis”) to render physicians deter


FDA approves first contact lens to slower the progression of nearsightedness in children


First contact lens has been approved by the U.S. Food and Drug Administration stipulated to slower the progression of myopia (nearsightedness) in children between the ages of 8


FDA cleared first Duodenoscope with Sterile, Disposable Component


The first duodenoscope with a sterile, disposable elevator piece was cleared for marketing by the US Food and Drug Administration (FDA). The components of disposable elevator wi


Stryker obtains US FDA 510(k) clearance for SAHARA lateral 3D expandable interbody system


Stryker, has receive the 510(k) clearance of its SAHARA Lateral 3D Expandable Interbody System featuring Lamellar 3D Titanium Technology, from the US Food and Drug Administration (FD


FDA clearance for hands-free XACT robotic system


Clearance for marketing has been granted by the US Food and Drug Administration (FDA) to XACT Robotics’ hands-free robotic system for usage in Computed Tomography (CT) guided p


Impulse Device receives PMA approval from FDA for heart failure device


PMA supplement approval was received by Impulse Dynamics for its next-generation; two lead Optimizer Smart System for treatment of heart failure by the US Food and Drug Administratio


Medical Device Developments: Finalization of Four 510(k) Guidance Documents by FDA


The U.S. Food and Drug Administration furnished multiple final guidance documents related to the medical device program. Here are the four guidance documents: final guidances on the


Draft Medical Devices Amendment Rules released by CDSCO for medical devices registration


Draft Medical Devices Amendment Rules, 2019 for registration of thirty six medical devices based on the Drugs Technical Advisory Board (DTAB) suggestions were released by the Union h


All medical devices to be brought under CDSCO to improve safety & quality


As per the government plans, all medical devices, including implants and contraceptives are to be brought under the Central Drugs and Standard Control Organisation to ensure improvem


US FDA approval to Secuado transdermal system of Noven Pharma for treating adults with schizophrenia


The US Food and Drug Administration (FDA) approval has been given to Secuado (asenapine) transdermal system which is the first-and-only transdermal patch formulation for the treatmen


6 months transition time approval to implement provisions of new Medical Device Rules, 2017


A transition time of 6 months has been approved by the Union health ministry for implementing provisions of new Medical Device Rules, 2017 for the requirement of switching inventory


US FDA approval to OssDsign for marketing Cranial PSI Accessories in US


The US Food and Drug Administration (FDA) has granted 510(k) clearance (K190523) for marketing OssDsign Cranial PSI Accessories in the US. The products which are cleared are a set of


Guidelines on performance evaluation of IVDs for grant of manufacturing and import licenses issued by CDSCO


Guidelines has been issued by the Central Drugs Standard Control Organisation (CDSCO) for evaluation of performance of In-Vitro Diagnostic (IVD) medical devices for grant of manufact


Breakthrough Device Designation for Heart Failure to Corvia Medical's Interatrial Shunt Device (IASD®)


A privately-held company, Corvia Medical, Inc., which has a first-in-class structural heart device for treatment of heart failure has received the Breakthrough Device designation by


NHS approval to Genedrive for baby deafness trial test


Genedrive a molecular diagnostics firm has obtained approval from the NHS Health Research Authority and ethics committee for the usage of the Antibiotic Induced Hearing (AIHL) test i


FDA Clearance to Biofourmis Analytics Engine for Ambulatory Physiologic Monitoring


Biofourmis has obtained 510(K) clearance for its machine-learning and artificial intelligence (AI)-powered analytics engine as a medical device for ambulatory physiological monitorin


FDA clearance obtained by for mobile-based CKD test

The test of can be performed at pharmacies, urgent care centres and health clinics, which eliminates the need for a tabletop lab device.

Furthermore, the test can also present im


FDA breakthrough device designation to Novel system for PAH

A breakthrough device designation has been granted by the FDA to a therapeutic intravascular ultrasound system for patients with pulmonary artery hypertension.

A therapeutic ultrasound cath


Moderato system wins CE Mark for treating hypertension: Orchestra

Orchestra BioMed, Biomedical company has received European CE-Mark approval for its Moderato implantable pulse generator system to treat patients with hypertension.

Moderato functions with


FDA granted breakthrough device designation to MagicTouch AVF sirolimus-coated balloon

FDA granted the breakthrough device designation for MagicTouch AVF, its sirolimus drug-coated balloon (DCB) catheter used for treating the stenotic lesions of arteriovenous fistulae or arteriovenou


US FDA breakthrough device status to Conceptualize Medical's Sirolimus DCB catheter, MagicTouch AVF

Concept Medical Inc. (CMI) wins US Food and Drug Administration (FDA) grant as “Breakthrough Device Designation” for MagicTouch AVF, its Sirolimus drug-coated balloon (DCB) catheter, fo


FDA approval to ApiFix MID-C system to treat adolescent idiopathic scoliosis

The US FDA has approved ApiFix for the commercialization of Minimally Invasive Deformity Correction (MID-C) system. This approval has been done through Humanitarian Device exemption for the treatme


Minimally Invasive Deformity Correction (MID-C) System - H170001 wins approval: USFDA

Minimally Invasive Deformity Correction (MID-C) System gets the USFDA approval to treat adolescent patients having idiopathic scoliosis. The intention of non-fusion spinal device known as Minimally


SAPIEN 3 Ultra Delivery System Recall by Edwards Lifesciences, LLC

The SAPIEN 3 Ultra delivery system of Edwards is being recalled by the organization. It is required for delivering and deploying the Edwards SAPIEN 3 Ultra transcatheter heart valve or the Edwards


Centurion Medical Products' Primary Warmer Pack and Primary Set Pack Recall: Medline Industries, Inc.

An announcement has been made regarding the recalling of Medline Primary Warmer Pack and Primary Set Pack which is used to help in the administration of intravenous (IV) fluids. 

The M


Centurion Medical Products' Primary Warmer Pack by Medline Industries, Inc. Recalled

An announcement has been made regarding the recalling of Medline Primary Warmer Pack, which is used to help in the administering of intravenous (IV) fluids. The Medline Primary Warmer Pack constitu


MED-EL Cochlear Implant System - P000025/S104 wins USFDA approval

The MED-EL Cochlear Implant System gets the USFDA approval to produce auditory sensations. The intention of MED-EL Cochlear Implant System is to produce auditory sensations by giving electric stimu


PD-L1 IHC 22C3 pharmDx - P150013/S016 wins USFDA approval

The lab test used by doctors for checking the protein programmed cell death ligand 1 (PD-L1) in tumor tissue obtained from patients, who have esophageal squamous cell cancer is done by PD-L1 IHC 22


Medical device manufacturer can now ask for FDA feedback after inspection

The FDA has notified in a draft that in coming times, they will offer nonbinding feedback after completion of their inspection at medical device manufacturer.

The FDA explained the complete


First spinal tether device wins the USFDA approval for treating idiopathic scoliosis

The US FDA has given the approval to first spinal tether device to be used in adolescents and children having idiopathic scoliosis. It is an alternative to surgical treatment.

The Zimmer Bi


The Tether™ - Vertebral Body Tethering System - H190005 grabs USFDA approval

The USFDA approval is granted to the Tether-Vertebral Body Tethering system. The intention of non-fusion spinal device known as Tether™ - Vertebral Body Tethering System is to treat idiopathi


Medtronic CoreValve System; Medtronic CoreValve Evolut R System; Medtronic CoreValve Evolut PRO System - P130021/S033 gets approval from USFDA

The USFDA gives the approval to CoreValue system developed by Medtronic. Three design iterations are present in the Medtronic CoreValve family of devices: the Medtronic CoreValve System (1st genera


USFDA approves Edwards SAPIEN 3 Transcatheter Heart Valve System - P140031/S085

The SAPIEN 3 Transcatheter Heart Valve (THV) System and Edwards SAPIEN 3 Ultra THV System of Edward, both consist of an artificial catheter-based aortic heart valve and accessories used for implant


BAROSTIM NEO System - P180050 wins USFDA approval

Barostim NEO system gets the USFDA approval to treat advanced heart failure. An implantable pulse generator (IPG), a carotid sinus lead kit and a programmer are included in the BAROSTIM NEO System.


FDA Breakthrough designation to V-Wave's Interatrial Shunt regarding Device Designation for Heart Failure

A privately held medical device company known as V-Wave Ltd., developing new implantable interatrial shunt devices receives the Breakthrough Device Designation from the U.S. Food and Drug Administr


Volumat MC Agilia Infusion Pump and Vigilant Agilia Drug Library Recall: Fresenius Kabi

Fresenius Kabi announced the recall of Volumat MC Agilia Infusion System which is an infusion pump used by health care professionals that delivers fluids including medications, blood, and blood pro


NvisionVLE Imaging System wins FDA clearance


NvisionVLE Imaging System can now be marketed by NinePoint Medical following clearance from the US FDA. It can give high-resolution volumetric images of the sub


CE marking to Meril Life Sciences for bioresorbable scaffold stent

Meril Life Sciences receives CE marking for their scaffold -MeRes100 BRS, becoming the first thin-strut bioresorbable scaffold. 

Cardiovascular related diseases such as coronary artery


USFDA approves Medtronic CoreValve Evolut R System and Medtronic CoreValve Evolut PRO System - P130021/S058

Both of the sytems, the Medtronic CoreValve Evolut R System and Medtronic CoreValve Evolut PRO gets the USFDA approval. Both consists of a transcatheter aortic valve (TAV), a delivery catheter, and


CE Mark approval wins by ExThera for Seraph 100

Seraph 100 by ExThera Medical, developed for pathogen reduction during bloodstream infection gets the CE Mark approval. Obtaining the CE mark approval confirms the safety of Seraph 100.



Abbott recalls Ellipse Implantable Cardioverter Defibrillators

Implantable cardioverter defibrillators with model numbers CD1377-36C, CD1377-36QC, CD1411-36Q, CD2377-36QC, CD2411-36C, CD2411-36Q manufactured between 05 April 2019 till 29 May 2019 are bein


OncoBEAM RAS CRC kit gets Japanese approval

Sysmex Corporation achieves the Japanese approval to manufacture and market OncoBEAM RAS CRC Kit. It is used in the patients of colorectal cancer for blood-based circulating tumour DNA molecular te


OncoBEAM RAS CRC kit gets Japanese approval

Sysmex Corporation achieves the Japanese approval to manufacture and market OncoBEAM RAS CRC Kit. It is used in the patients of colorectal cancer for blood-based circulating tumour DNA molecular te


Medical device manufacturing sites will be audited by 6 bodies: CDSCO

According to the new MD Rules, the 6 bodies are notified by the CDSCO to audit the medical device manufacturing sites.

The new MD Rules 2017 became effective since 01 January 2018. These ru


Filter Tips by QIAGEN recalled due to inaccurate or delayed results

1500 µl filter tips to be used with QIAGEN QIAsymphony SP/AS instruments, model number REF 997024 with lot number 0605020019 and 0605020020 are recalled due to delayed or incorrect results.


FDA Draft guidance on Medical Device’s Safety in MRI Environment

A new draft guidance namely Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment has been issued by the U.S. Food and Drug Administration (FDA).



USFDA: Green signal to PD-L1 IHC 22C3 pharmDx - P150013/S014

The USFDA grants green signal to PD-L1 IHC 22C3 pharmDX. The lab test used by doctors for checking head and neck squamous cell cancer having programmed cell death ligand 1 (PD-L1) in their cancer i


Welch Allyn RetinaVue 700 Imager Launched by Hillrom

Hillrom launches the Welch Allyn RetinaVue 700 Imager, a retinal camera to detect diabetic retinopathy. It is a recent innovative diagnostic technology.

It helps distant ophthalmologists to


Delivering accurate chest compression now becomes easy
The researchers from University of Applied Sciences and Fraunhofer Institute for Silicate Research have developed a device, named Rescue Aid. It assists in administering the ch


Improvement in Powered Prosthetic Arms by Implanted Electrodes

In recent times, few built-in electrodes are present in conventional powered prosthetic arms that make connection with skin of the patient. These are good enough to open and close a simple claw, bu


ECG, Breathing, Heart Rate measurement continuously for weeks using Flexible Body Monitor

Long-term continuous monitoring of physiological activity can impart precise information about an individual’s health. Children, elderly, and people with varied conditions often face difficul


Rescue Aid to deliver accurate chest compressions

It is well known that perfectly delivered chest compressions can save an individual from cardiac arrest. However, this is not an easy task for the bystanders to perform the resuscitation because in


Quality requirement draft on combination products: EMA

A draft guideline is published by the European Medicines Agency (MEA) on quality requirements for medical devices and medicinal products combination. This combination is also known as Drug device c


Medical device’s encryption standards ‘needs to be compulsory’

An internet of things (IoT) company has warned that it is necessary to legally enforce the encryption standards on the medical devices. Encryption is mandatory for both developers and users. This i


Johnson and Johnson’s faulty hip implants issue raised in Rajya Sabha

Anand Sharma, congress leader, requested the current government to make the regulatory norms more stringent so that the incident like Johnson & Johnson’s selling faulty hip implants shoul


Aortix system of Procyrion received Breakthrough Device Designation from FDA

The Aortix system of Procyrion Inc. has secured the Breakthrough Device designation from the U.S. Food and Drug Administration (FDA). It is a percutaneous circulatory support system for medical-con


Medtronic’s VenaSeal Closure System unveiled in India treat CVD patients

Medtronic Private Limited has launched its VenaSeal Closure System in India to treat the people suffering from chronic venous disease (CVD). It is an invasive procedure in which the diseased vein i


MDTAG constituted by Health ministry

A Medical Devices Technical Advisory Group (MDTAG) has been constituted by the Union Health Ministry. The group will be giving advice to the Central Drugs Standard Control Organization (CDSCO) on m


Bausch and Lomb’s faulty adrenaline auto-injector gets Regulatory warning

The UK MHRA has announced in the alert letter that about 0.23% syringe pens (2.3 pens in every 1,000) manufactured by Bausch & Lomb fails to deliver adrenaline’s dose due to needle blocka


Microfluidics device developed for sepsis diagnosis

An automated, microfluidics device has been developed by the researchers from Massachusetts Institute of Technology (MIT) in the US. It will help in the detection of sepsis with 25 minutes.


Medical Device Cybersecurity Recommendations drafted by France

The draft recommendations on the cybersecurity of medical devices have been developed by France’s National Agency for the Safety of Medicines and Health Products (ANSM).

These recomme


All Intra-Aortic Balloon Pump models recalled by Maquet

The FDA has recognized the recall of Maquet/Datascope Intra-Aortic Balloon Pumps (IABP), models Cardiosave Hybrid, Cardiosave Rescue, CS300 and CS100/100i, as the Class Ⅰ recall.



Medtronic to make’s AI stroke detection software

Medtronic, an Irish medical technology firm, has decided to make the artificial intelligence (AI)-based stroke care solutions provider’s new technology available to different centers i


First cochlear device for single-sided deafness approved by FDA

Med-El North America, a Durham, N.C.-based firm has received an approval from the FDA for its cochlear implant system. This new device is first of its kind that can be used in people with single-si


Digital Inhaler approved for Asthma patients: FDA

AirDuo Digihaler (fluticasone propionate 113mcg and salmeterol 14mcg), an inhalation powder, has been approved by the FDA. It is meant for asthma treatment in patients aged 12 years and older, but