Medical Device Newsletter

26-07-2021

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

25-07-2021

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

25-07-2021

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.

25-07-2021

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

25-07-2021

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 (

25-07-2021

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

25-07-2021

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

24-07-2021

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

23-07-2021

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

23-07-2021

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

23-07-2021

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

23-07-2021

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

22-07-2021

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

22-07-2021

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

22-07-2021

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

22-07-2021

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

22-07-2021

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

21-07-2021

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

21-07-2021

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

21-07-2021

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

21-07-2021

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

21-07-2021

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

16-07-2021

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

16-07-2021

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

14-07-2021

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

14-07-2021

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

14-07-2021

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

14-07-2021

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.

13-07-2021

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

13-07-2021

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.

13-07-2021

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

13-07-2021

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,

13-07-2021

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

13-07-2021

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

12-07-2021

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,

12-07-2021

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

12-07-2021

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

10-07-2021

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

Viz.ai obtains a CE mark for AI-based stroke care software

Viz.ai 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

10-07-2021

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

10-07-2021

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

10-07-2021

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

10-07-2021

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

10-07-2021

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

10-07-2021

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

10-07-2021

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

10-07-2021

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

09-07-2021

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

09-07-2021

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

07-07-2021

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

07-07-2021

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

06-07-2021

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

05-07-2021

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

05-07-2021

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

05-07-2021

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

05-07-2021

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. 

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25-06-2021

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

25-06-2021

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

25-06-2021

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

24-06-2021

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

24-06-2021

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

24-06-2021

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

23-06-2021

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

23-06-2021

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

22-06-2021

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

22-06-2021

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 (

22-06-2021

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

22-06-2021

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

21-06-2021

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

21-06-2021

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

21-06-2021

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

19-06-2021

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

19-06-2021

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

19-06-2021

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

18-06-2021

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

17-06-2021

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

17-06-2021

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

17-06-2021

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

17-06-2021

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

16-06-2021

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

15-06-2021

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

15-06-2021

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

15-06-2021

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

14-06-2021

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.

14-06-2021

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

14-06-2021

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.

26-05-2021

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. 

26-05-2021

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

26-05-2021

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

25-05-2021

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

24-05-2021

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

24-05-2021

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

24-05-2021

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

24-05-2021

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 (

24-05-2021

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

21-05-2021

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.&

21-05-2021

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

21-05-2021

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

21-05-2021

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

21-05-2021

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

21-05-2021

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

21-05-2021

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

21-05-2021

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

20-05-2021

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

19-05-2021

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

18-05-2021

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

18-05-2021

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

17-05-2021

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. 

A

17-05-2021

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

17-05-2021

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

15-05-2021

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

14-05-2021

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

14-05-2021

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

14-05-2021

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

12-05-2021

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

07-05-2021

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

27-04-2021

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

27-04-2021

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

27-04-2021

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

23-04-2021

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

22-04-2021

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.<

22-04-2021

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

22-04-2021

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

13-04-2021

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.

The

10-04-2021

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

09-04-2021

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

09-04-2021

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

09-04-2021

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

07-04-2021

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

05-04-2021

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.

13-03-2021

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

11-03-2021

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

11-03-2021

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

11-03-2021

Rigenerand collaborates with Lacopa to distribute VITVO 3D cell culture technology

 

Rigenerand SRL, the biotech company, inks the distribution agreement with

10-03-2021

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

10-03-2021

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

10-03-2021

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.

08-03-2021

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

08-03-2021

Abbott's Alinity m Resp-4-Plex molecular assay gets US FDA EUA

 

Abbott announced the US FDA EUA (Emergency Use Authorization) for Alinity

05-03-2021

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

05-03-2021

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

05-03-2021

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

04-03-2021

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

04-03-2021

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

04-03-2021

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

03-03-2021

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.

02-03-2021

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

02-03-2021

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

01-03-2021

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

27-02-2021

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

27-02-2021

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

25-02-2021

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

25-02-2021

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,

28-01-2021

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

28-01-2021

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.

27-01-2021

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,

27-01-2021

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

26-01-2021

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

26-01-2021

Chondro3 receives US FDA breakthrough device designation: Locate Bio

 

Locate Bio declared that the U

25-01-2021

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

23-01-2021

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

23-01-2021

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

22-01-2021

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

21-01-2021

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

20-01-2021

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

20-01-2021

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

18-01-2021

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.

18-01-2021

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

18-01-2021

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

16-01-2021

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

15-01-2021

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

15-01-2021

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

13-01-2021

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

06-01-2021

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

02-01-2021

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

02-01-2021

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

29-12-2020

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

23-12-2020

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

22-12-2020

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

22-12-2020

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

22-12-2020

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

22-12-2020

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.

Qui

17-12-2020

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

17-12-2020

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

12-12-2020

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

10-12-2020

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.

10-12-2020

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

09-12-2020

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

08-12-2020

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

08-12-2020

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,

07-12-2020

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

07-12-2020

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

04-12-2020

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

04-12-2020

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

23-11-2020

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

23-11-2020

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

10-11-2020

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

10-11-2020

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

10-11-2020

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

10-11-2020

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

10-11-2020

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

06-11-2020

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

06-11-2020

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

04-11-2020

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

02-11-2020

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

01-11-2020

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

31-10-2020

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

31-10-2020

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.

Mamm

30-10-2020

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

29-10-2020

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

28-10-2020

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

27-10-2020

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),

26-10-2020

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

26-10-2020

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

26-10-2020

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

25-10-2020

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

24-10-2020

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

23-10-2020

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

17-10-2020

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

16-10-2020

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)

16-10-2020

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

15-10-2020

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

15-10-2020

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

15-10-2020

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

13-10-2020

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

09-10-2020

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

08-10-2020

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

08-10-2020

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.

03-10-2020

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

03-10-2020

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

03-10-2020

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

01-10-2020

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

29-09-2020

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

28-09-2020

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

27-09-2020

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

25-09-2020

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

25-09-2020

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

24-09-2020

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

24-09-2020

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

24-09-2020

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

23-09-2020

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

22-09-2020

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

21-09-2020

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

08-09-2020

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

04-09-2020

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

02-09-2020

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

31-08-2020

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

31-08-2020

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

28-08-2020

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

28-08-2020

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

28-08-2020

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

28-08-2020

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 (

27-08-2020

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

27-08-2020

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

26-08-2020

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

24-08-2020

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

23-08-2020

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

22-08-2020

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

20-08-2020

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

26-05-2020

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

12-03-2020

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

11-03-2020

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

10-03-2020

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

09-03-2020

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

08-03-2020

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

07-03-2020

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

07-03-2020

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

07-03-2020

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

07-03-2020

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

06-03-2020

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

06-03-2020

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

06-03-2020

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

06-03-2020

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

05-03-2020

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

05-03-2020

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

05-03-2020

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

03-03-2020

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

03-03-2020

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

29-02-2020

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

29-02-2020

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

29-02-2020

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

29-02-2020

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

28-02-2020

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

28-02-2020

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

24-02-2020

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

23-02-2020

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

22-02-2020

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

22-02-2020

As per ICRA, medical devices to be brought under Drugs Act to assist in medical device regulation effectively

 

ICRA has co

20-02-2020

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

19-02-2020

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

14-02-2020

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

14-02-2020

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

13-02-2020

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

13-02-2020

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

13-02-2020

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

13-02-2020

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.

13-02-2020

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

12-02-2020

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

12-02-2020

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

12-02-2020

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

11-02-2020

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

11-02-2020

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

10-02-2020

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

10-02-2020

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

10-02-2020

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

28-01-2020

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

28-01-2020

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

18-01-2020

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

17-01-2020

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

17-01-2020

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

17-01-2020

Team discovers a way to eliminate GI device without the usage of endoscopy

 

Scholars at Massachu

17-01-2020

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

16-01-2020

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

14-01-2020

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

14-01-2020

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)

14-01-2020

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

13-01-2020

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

13-01-2020

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

10-01-2020

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

10-01-2020

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

10-01-2020

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 (

10-01-2020

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

08-01-2020

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

08-01-2020

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

07-01-2020

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

07-01-2020

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

07-01-2020

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

02-01-2020

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

30-12-2019

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

28-12-2019

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

27-12-2019

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

26-12-2019

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

26-12-2019

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

26-12-2019

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

25-12-2019

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

24-12-2019

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

24-12-2019

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

24-12-2019

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

23-12-2019

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

23-12-2019

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

22-12-2019

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&

22-12-2019

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

22-12-2019

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

20-12-2019

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

20-12-2019

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

20-12-2019

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

20-12-2019

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

19-12-2019

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

19-12-2019

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

19-12-2019

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

19-12-2019

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

19-12-2019

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

19-12-2019

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

18-12-2019

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

18-12-2019

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

17-12-2019

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

17-12-2019

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

17-12-2019

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

17-12-2019

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

17-12-2019

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

16-12-2019

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

16-12-2019

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

16-12-2019

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

16-12-2019

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

13-12-2019

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

13-12-2019

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.

13-12-2019

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

12-12-2019

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

11-12-2019

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

11-12-2019

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

11-12-2019

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

11-12-2019

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

10-12-2019

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,

09-12-2019

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

06-12-2019

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

06-12-2019

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

06-12-2019

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

05-12-2019

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

05-12-2019

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

05-12-2019

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

05-12-2019

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

27-11-2019

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

27-11-2019

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

27-11-2019

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

26-11-2019

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

26-11-2019

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

25-11-2019

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)

23-11-2019

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

15-11-2019

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

15-11-2019

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

02-11-2019

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

01-11-2019

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

31-10-2019

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

30-10-2019

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

24-10-2019

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

18-10-2019

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

17-10-2019

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

15-10-2019

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

15-10-2019

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

14-10-2019

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

09-10-2019

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

07-10-2019

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

04-10-2019

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

12-09-2019

FDA clearance obtained by Healthy.io for mobile-based CKD test

The test of Healthy.io 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

09-09-2019

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

05-09-2019

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

02-09-2019

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

31-08-2019

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

28-08-2019

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

23-08-2019

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

22-08-2019

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

21-08-2019

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

21-08-2019

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

21-08-2019

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

20-08-2019

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

19-08-2019

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

18-08-2019

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

16-08-2019

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

16-08-2019

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

16-08-2019

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

16-08-2019

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.

15-08-2019

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

12-08-2019

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

09-08-2019

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

09-08-2019

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

09-08-2019

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

07-08-2019

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.

&nb

05-08-2019

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

05-08-2019

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

05-08-2019

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

02-08-2019

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

02-08-2019

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.

02-08-2019

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).

Unique

02-08-2019

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

01-08-2019

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

01-08-2019

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

01-08-2019

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

01-08-2019

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

01-08-2019

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

31-07-2019

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

31-07-2019

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

31-07-2019

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

30-07-2019

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

27-07-2019

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

26-07-2019

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

25-07-2019

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

24-07-2019

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.

23-07-2019

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

23-07-2019

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.

IABP, a

23-07-2019

Medtronic to make Viz.ai’s AI stroke detection software

Medtronic, an Irish medical technology firm, has decided to make the artificial intelligence (AI)-based stroke care solutions provider Viz.ai’s new technology available to different centers i

23-07-2019

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

16-07-2019

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