Sorrento Therapeutics declared that its agents in Mexico had submitted a Marketing Authorization Application to Mexico's health regulatory authority for its COVI-STIX rapid diagnosti

Micro-Tech Endoscopy and Interscope Inc signed a partnership agreement to collaborate and distribute the EndoRotor System for interventional gastroenterology. 

It is a s

Fitgo has come up with a range of infrared thermometers with the latest technology that may be launched worldwide. The new devices have advanced sensor technology that gives results

Medtronic India launched EEA™ Circular Stapler with Tri-Staple™ Technology. It is touted as the first 3-row Circular Stapler with varied height staples causing lesser str

Health Canada granted its approval to Medtronic Canada's Micra AV pacemaker with atrioventricular synchrony. The USFDA approved the device in January 2020. 

The leadless

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

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

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

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

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

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

The Central government has launched a new digital platform called Co-WIN for COVID-19 vaccine delivery. There will be a new mobile app and will allow people vaccine registration.

HealthiumMedtech 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

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

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

QIAGEN declared the launch of its QuantiFERON SARS-CoV-2 Research Use Only (RUO) solution to detect T-cell responses of the immune system to the COVID-19 causing pathogen in humans,

Omron 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

The scientists from CCMB (Centre for Cellular and Molecular Biology), Hyderabad, have designed an innovative and most effective COVID-19 testing technique utilizing dry swabs, which

MEQU, 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

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

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

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

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

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

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

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

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

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

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

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

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

Kochi-based medical devices manufacturer, Agappe Diagnostics Ltd, is launching a new Covid-19 test kit on November 10, based on Reverse Transcription Loop-mediated Isothermal Amplifi

PerkinElmer, Inc. declared that the US Food and Drug Administration (FDA) had granted Emergency Use Authorization (EUA), which allows sample pooling with PerkinElmer New Coronavirus

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

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

Global Diagnostic firm Genbody Inc has received the Indian Council of Medical Research and Drugs Controller General of India's approval for "Genbody Covid-19 AG" antigen test kits to

Cipla 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

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),

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

US Food & Drug Administration (FDA) granted 510(k) clearance to the Vial2Bag Advanced 20mm Admixture Device from West Pharmaceutical Services Inc. The company has announced its l

Bayer's FoundationOneCDx for use as the first companion diagnostic gets US FDA approval for identifying neurotrophic receptor tyrosine kinase (NTRK) gene fusion-positive patients whe

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

Scientists have come up with a novel tool to assist physicians and speed up stroke diagnosis in clinical settings. The new tool based on machine learning may help diagnose stroke and

Tyber Medical 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

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

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)

The University of Colorado researchers have come up with a novel test based on ultrasound technology to detect sickle cell disease. The miniature size of the device, its swift mechan

Abbott Healthcare introduced its new heart rhythm management devices, Implantable Cardioverter Defibrillator (ICD) and Cardiac Resynchronisation Therapy Defibrillator (CRT-D) in Indi

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

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

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

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

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

Zydus Cadila launched India's first pressurized Metered Dose Inhaler (pMDI), ForglynpMDI, for Chronic Obstructive Pulmonary Disease (COPD) patients in India. With a price tag of Rs.

SyntheticMR 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

Almost the entire range of WaveWriter Alpha Spinal Cord Stimulator (SCS) Systems was officially launched in Europe by Boston Scientific, a global medi-tech giant. It includes four MR

Japan'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

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

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

FreeStyle Libre 3, the latest continuous glucose monitoring (CGM) device from Abbott, received the CE mark, thereby paving the way for its commercial launch in the European market. A

Equine Biotech, 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

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

WaveForm C Interbody Implant System was launched commercially by SeaSpine. The global medical technology giant plans to launch four more devices by mid-2021.

The novel WaveFo

KardiaMobile 6L, 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

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

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

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

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

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

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

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

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

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

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

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

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

Nocca Robotics Pvt Ltd, of SIIC, IIT Kanpur, launched a clinically validated and certified High- Flow Oxygen Therapy Device for COVID-19 patients. The device is high-quality critical

Abbott 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 (

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

The US Food and Drug Administration (FDA) approves Foundation Medicine's pan-tumor liquid
biopsy test FoundationOne Liquid CDx.

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

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

HFNO has become synonymous with a bridge between mask and ventilator. It is replacing the invasive mechanical ventilation for treatment of respiratory distre

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

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

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

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

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

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

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

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

By conducting a few simple physical exercises routinely, and getting data about their disease regularly, 500 osteoarthritis patients were able to on average halve their pai

Excillum 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

Diagnostics company SphingoTec GmbH announced on new information on the utility of endothelial function biomarker bioactive Adrenomedullin (bio-ADM®). The data demonstr

The Sree Chitra Tirunal Institute for Medical Sciences and Technology (SCTIMST), Thiruvananthapuram, which is an institute of national importance, has created an innovative intr

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

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

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

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

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

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

An institute of national importance, the Sree Chitra Tirunal Institute for Medical Sciences and Technology (SCTIMST), Thiruvananthapuram, has created a nickel-titanium allo

An enhanced mobile phone app will aid in identifying women who require special treatments at the right time and lower the emotional and financial burden on families and the

Avanos Medical has gained clearance from the US Food and Drug Administration (FDA) for selling its 80W COOLIEF Radiofrequency (RF) system for neurological lesion procedures

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

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

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

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

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

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

A new device to treat of intracranial aneurysms, Contour Neurovascular System has achieved European CE Mark approval, declared medical device company Cerus Endovascular. Th

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

Novacyt, an Anglo-French Company specializes in clinical diagnostics currently declared that its molecular diagnostics division, Primerdesign, has introduced its CE-Mark mo

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

Prior this month, Eko, an artificial intelligence (AI) digital health company, was approved FDA approval for its latest cardio-technology.

The US-based co

University College London Researchers have utilized artificial intelligence for the first time to instantly and precisely measure blood flow. Utilization of Artificial inte

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

The US Food and Drug Administration (FDA) have approved 510(k) clearance to bedside Magnetic Resonance Imaging (MRI) system of Hyperfine Research.

The fir

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

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.

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

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

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

At current scenario patients have to move to a location of a high-field MRI device for diagnosis of stroke causing vital delay in diagnosis. However, Advancement in low-fie

icometrix has gained 510(k) clearance from the US Food and Drug Administration (FDA) for its icobrain ep solution.

Icobrain ep assists in identification o

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

Caption Health has gained authorization from the US Food and Drug Administration (FDA) for marketing its cardiac ultrasound software.

Caption Guidance, th

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

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

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

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

Researchers, involving one of Indian-origin, have created an artificial intelligence (AI) tool that can precisely detect modifications in clinical states in voice data of p

Siemens Healthineers which is a medical technology company has initiated its first manufacturing facility in Bengaluru, which will complement its existing R&D centre. T

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

Scholars at Scripps Research Translational Institute have discovered that fitness tracker devices – wearable tracker devices that calculate heart rate and sleep durat

A unit of Hoya Group, Pentax Medical, has received 510(k) clearance from the US Food and Drug Administration (FDA) for its IMAGINA endoscopy system.

The endoscopy platform wa

Medtronic 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

501(k) clearance has been granted to the US Food and Drug Administration (FDA) for radiology company Aidoc’s AI-based system for the recognition of large-vessel occlusion (LVO)

Phagenesis declared that it has secured breakthrough device designation from the FDA for its Phagenyx System for restoring neurological swallowing control.

The Phagenyx Syste

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

A late-stage biotechnology company known as CytoDyn Inc. is committed on developing leronlimab (PRO 140), a CCR5 antagonist with the capability for multiple therapeutic ind

Researchers 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

KDx Diagnostics, a company committed on developing non-invasive cancer tests to enhance early detection and therapy decisions in cancer, declared that the Food and Drug Adm

Silver Bullet Therapeutics which is US-based medical device company has gained CE Mark approval for the commercial sale of its antimicrobial bone screw system in the European Union (

Reflow Medical has obtained breakthrough device designation for its Temporary Spur Stent System from the US Food and Drug Administration (FDA).

The retrievable stent tec

Abbott 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

Abbott declared that the US Food and Drug Administration (FDA) has granted approval to a new alternative surgical technique for Abbott's HeartMate 3 heart pump that will permit

Cognetivity Neurosciences Ltd. declared that its Integrated Cognitive Assessment (ICA) software has been granted as a CE-marked medical device. The declaration follows Cognetivi

510(k) clearance for PhotoniCare’s TOMi Scope has been granted by the US Food and Drug Administration (FDA) for non-invasive imaging of the middle ear to diagnose ear infe

Bioness, a US-based medical technology company has gained CE Mark approval for its StimRouter neuromodulation system for treatment faecal incontinence.

The small implant

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

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

Scholars and researchers at the Indian Institute of Technology (IIT), Roorkee have made bioresorbable and economical orthopaedic implants to heal bone fractures.

The recent s

Invention of cost-effective bio-resorbable orthopaedic implants for healing bone fractures were done by the researchers of IIT Roorkee. The recent strategies of therapeutic to h

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

Siemens Healthineers has shipped its 1st indigenous CT scanner from its currently launched prior art medical imaging factory in Bengaluru. The Somatom g

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

Jaw and bone implants specific with patients can now be developed and created within the country, inside IARM (innovative additive research and manufacturing) laboratory establi

FDA 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

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

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

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

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

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&

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

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

IRRAS received CE mark approval for its IRRAflow catheter. The new approval is gained after the company obtained 2 CE marks for its IRRAflow system’s tube set with a digital pu

Recalling 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

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

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

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

Eko which is Digital Health Company secured breakthrough device designation from FDA for priority review of the algorithm to detect heart failure of company with a specialized stetho

FDA proclaimed regarding a warning letter to Conformis, a Massachusetts-based customized joint implant manufacturer, quoting sterilization issues regarding the knee replacement syste

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

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

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

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

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

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

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

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

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

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

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

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

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

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.

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

A global medical device company known as LimaCorporate obtains the FDA 510K approval for Smart SPACE Shoulder 3D Planner & 3D Positioner. Being an innovative digital platform, Sm

Breakthrough device designation status has been obtained by Beta Bionics from the US Food and Drug Administration (FDA) for its iLet Bionic Pancreas System. iLet Bionic Pancreas is a

CE mark 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

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

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,

Issuance of a draft guidance document was done by FDA describing the performance criteria that producers of radio frequency coils for magnetic resonance imaging (MRI) can utilize to

Breakthrough Therapy Designation was granted by the US Food and Drug
Administration (FDA) to Bristol-Myers Squibb Company for ORENCIA (abatacept) for the moderate to severe acut

Mainstay Medical International received regulatory approval from the Australian Therapeutic Goods Administration (TGA) for ReActiv8, its implantable restorative neurostimulation syst

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

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

“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

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

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

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

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

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

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

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

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)

Japan’s Ministry of Health, Labour and Welfare (MHLW) has given consent to the BRACAnalysis Diagnostic System (i.e., “BRACAnalysis”) to render physicians deter

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

The first duodenoscope with a sterile, disposable elevator piece was cleared for marketing by the US Food and Drug Administration (FDA). The components of disposable elevator wi

Stryker, 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

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

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

The U.S. Food and Drug Administration furnished multiple final guidance documents related to the medical device program. Here are the four guidance documents: final guidances on the

Draft Medical Devices Amendment Rules, 2019 for registration of thirty six medical devices based on the Drugs Technical Advisory Board (DTAB) suggestions were released by the Union h

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

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

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

The US Food and Drug Administration (FDA) has granted 510(k) clearance (K190523) for marketing OssDsign Cranial PSI Accessories in the US. The products which are cleared are a set of

Guidelines 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

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

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

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

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

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

Orchestra BioMed, Biomedical company has received European CE-Mark approval for its Moderato implantable pulse generator system to treat patients with hypertension.

Moderato functions with

FDA granted 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

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

The US FDA has approved ApiFix for the commercialization of Minimally Invasive Deformity Correction (MID-C) system. This approval has been done through Humanitarian Device exemption for the treatme

Minimally Invasive Deformity Correction (MID-C) System gets the USFDA approval to treat adolescent patients having idiopathic scoliosis. The intention of non-fusion spinal device known as Minimally

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

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

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

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

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

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

The US FDA has given the approval to first spinal tether device to be used in adolescents and children having idiopathic scoliosis. It is an alternative to surgical treatment.

The Zimmer Bi

The 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

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

The SAPIEN 3 Transcatheter Heart Valve (THV) System and Edwards SAPIEN 3 Ultra THV System of Edward, both consist of an artificial catheter-based aortic heart valve and accessories used for implant

Barostim NEO system 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.

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

Fresenius Kabi announced the recall of Volumat MC Agilia Infusion System which is an infusion pump used by health care professionals that delivers fluids including medications, blood, and blood pro

NvisionVLE Imaging System can now be marketed by NinePoint Medical following clearance from the US FDA. It can give high-resolution volumetric images of the sub

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

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

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.

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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

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

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

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

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.

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

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

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

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

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

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

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

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

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

The Aortix system of Procyrion Inc. has secured the Breakthrough Device designation from the U.S. Food and Drug Administration (FDA). It is a percutaneous circulatory support system for medical-con

Medtronic 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

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

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

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.

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

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

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

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

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