FDA Archives - TMG Pulse

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AI FDA Radiology

FDA-cleared AI devices lack critical information on performance, equity

The Food and Drug Administration is greenlighting AI tools at a faster pace, from computer […]

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FDA MedTech Pharmaceutical

Genentech wins FDA approval for Xolair prefilled syringe

Genentech announced today that the FDA approved its supplemental biologics license application for the Xolair […]

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FDA MedTech Pharmaceutical

Regeneron, Roche injectable antibody drug shows efficacy in preventing Covid-19

A Covid-19 antibody cocktail developed by Regeneron Pharmaceuticals and Roche has pivotal clinical trial data […]

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FDA MedTech

FDA slaps Class I label on rapid infuser recall

The FDA today declared that the recall of an emergency infusion device kit is the […]

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AI FDA MedTech

FDA greenlights Medtronic’s AI tool that finds polyps during colonoscopies

The Food and Drug Administration has granted De Novo authorization to GI Genius, the first-of-its-kind […]

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FDA MedTech

FDA flags infection risk from reusable urological endoscopes

The FDA said today that is looking into the causes of infections from reprocessed urological […]

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FDA MedTech Neuro

Non-invasive PoNS device receives marketing authorisation from FDA 

Helius Medical Technologies has announced that its Portable Neuromodulation Stimulator (PoNS) device, for multiple sclerosis sufferers, […]

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FDA MedTech Surgery

FDA warns on use of certain surgical mesh in breast reconstruction

Two brands of surgical mesh used off-label in breast reconstruction surgery have had “significantly higher […]

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FDA MedTech Oncology

BlueStar Genomics gains breakthrough nod for pancreatic cancer test

Bluestar Genomics announced today that it received FDA breakthrough device designation for its pancreatic cancer […]

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Cardiology FDA Vascular

B. Braun, Infraredx to collaborate on drug-coated balloon catheter IDE study

B. Braun Interventional Systems (BIS) announced today that it is collaborating with Infraredx on a […]

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FDA MedTech Neuro

Device to help MS patients walk gains FDA breakthrough nod

The FDA has authorized a new device to help adults with mild to moderate […]

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FDA MedTech Neuro

Helius gets FDA nod for neuromodulator after pivoting to multiple sclerosis

Dive Brief: FDA has authorized Helius Medical Technologies’ neuromodulation stimulator to improve the gait of multiple […]

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Biotech FDA

Amazon lands EUA for COVID-19 test with home sample collection

On Thursday, Amazon landed an FDA Emergency Use Authorization for its COVID-19 test kit with […]

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AR/VR FDA Pain Management

AppliedVR raises $29M as it seeks FDA clearance of VR system for pain treatment

AppliedVR received a breakthrough device designation last year for its VR system for treating chronic […]

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FDA MedTech Neuro

Medtronic receives FDA approval for labelling of Intellis platform when using DTM SCS

Medtronic has announced that the US Food and Drug Administration (FDA) has approved the revised […]

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FDA Imaging MedTech

GE Healthcare 2D/3D imaging system wins FDA nod

GE Healthcare has announced FDA 510(k) clearance for a new surgical imaging system capable […]

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Diagnostics FDA MedTech

FDA grants EUA to COVID-19 screening device using machine learning

Dive Brief: FDA has granted emergency use authorization to a machine learning system designed to […]

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FDA MedTech

CMS delays Medicare coverage of breakthrough devices

Medicare coverage for FDA-designated breakthrough medical devices will have to wait, despite broad support. The […]

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FDA MedTech

A Major Turning Point for COVID-19-Related Diagnostics

In a first for the industry, FDA has granted marketing authorization to a SARS-CoV-2 test […]

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FDA MedTech

FDA streamlines pathway to at-home asymptomatic COVID-19 test approval

This week, the Food and Drug Administration shared that it will allow marketing for some COVID-19 screening […]

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FDA Funding MedTech

Viz.ai Proves AI is Still ‘Relevant’ in Medtech with $71M Financing

Viz.ai has raised $71 million in a series C round to expand its artificial intelligence […]

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FDA MedTech

FDA clears Catalyst OrthoScience reverse shoulder system

Catalyst OrthoScience today announced that it received FDA 510(k) clearance for its reverse shoulder system. […]

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FDA MedTech

FDA seeks to ease path to COVID screening test nods

The FDA today published information to help developers of tests to screen asymptomatic people for […]

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Cardiology FDA MedTech

Abbott halts trial enrollment for HeartMate PHP catheter blood pump

Dive Brief: Abbott Laboratories has suspended enrollment in its trial of the HeartMate PHP catheter […]

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FDA FDA Approved Spine

PMA submission process initiated for FDA approval of Limiflex

Empirical Spine, maker of the LimiFlex paraspinous tension band, has announced initiation of the PMA […]

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FDA Implantables Neuro Ophthalmology

Second Sight gains FDA nod for retinal system that may never be produced

Second Sight Medical (NSDQ: EYES) today announced that the FDA has approved its Argus 2s retinal […]

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FDA MedTech Spine

ReFlow system mini receives FDA breakthrough device designation

Anuncia has announced that it has received US Food and Drug Administration (FDA) breakthrough device designation […]

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AR/VR FDA Pain Management

With results of pivotal study, AppliedVR to seek FDA clearance

AppliedVR’s program includes a feature for users to go through guided breathing exercises, which are […]

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FDA Healthcare MedTech

Icometrix announces ischaemic stroke solution

In a press release, icometrix announced the addition of icobrain cva, a stroke solution, to the icobrain portfolio. According to […]

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FDA MedTech

BrainStorm’s NurOwn does not have enough clinical data according to FDA

BrainStorm Cell Therapeutics announced it recently met with senior leadership from the US Food and Drug […]

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FDA Wearables

Bone-Stimulating Device Uses NASA-Developed Tech to Help Prevent Osteoporosis

After bone density peaks, typically when people reach their 30s, most experience a slow decline […]

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FDA MedTech

FDA panel votes against BD Lutonix drug-coated balloon for below-the-knee

An FDA advisory panel voted against a favorable recommendation for BD‘s Lutonix catheter-based, drug-coated balloon for […]

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FDA MedTech Patient Monitoring

New FDA medtech cybersecurity chief: Guidance to debut in 2021

The FDA’s first medical device cybersecurity chief says he will work across private and public […]

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FDA Neuro Vascular

Cerus Endovascular neurovascular system wins FDA breakthrough device designation

Cerus Endovascular today said it has received FDA breakthrough device designation for its Contour Neurovascular System. […]

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FDA MedTech Vascular

Vascular Perfusion Solutions lands FDA breakthrough nod for organ-transport device

The FDA has granted startup Vascular Perfusion Solutions (San Antonio, Tex.) breakthrough device designation […]

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Digital Health FDA MedTech

First daytime treatment for obstructive sleep apnea receives De Novo authorization

The FDA has granted De Novo authorization to what will be the first device treatment […]

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Drug-delivery FDA

Johnson & Johnson applies for vaccine approval from FDA

Johnson & Johnson (NYSE:JNJ) announced that it submitted an FDA emergency use authorization (EUA) application for […]

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FDA MedTech Vascular

Medtronic wins FDA approval for DiamondTemp ablation system

Medtronic (NYSE:MDT) announced today that it received FDA approval for its DiamondTemp ablation (DTA) system for […]

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FDA MedTech

FDA Adds New Regulatory Science Tools for Assessing Medical Devices

FDA recently added five tools to its catalog of regulatory science tools to help assess medical […]

Topic: FDA

FDA-cleared AI devices lack critical information on performance, equity

Genentech wins FDA approval for Xolair prefilled syringe

Regeneron, Roche injectable antibody drug shows efficacy in preventing Covid-19

FDA slaps Class I label on rapid infuser recall

FDA greenlights Medtronic’s AI tool that finds polyps during colonoscopies

FDA flags infection risk from reusable urological endoscopes

Non-invasive PoNS device receives marketing authorisation from FDA

FDA warns on use of certain surgical mesh in breast reconstruction

BlueStar Genomics gains breakthrough nod for pancreatic cancer test

B. Braun, Infraredx to collaborate on drug-coated balloon catheter IDE study

Device to help MS patients walk gains FDA breakthrough nod

Helius gets FDA nod for neuromodulator after pivoting to multiple sclerosis

Amazon lands EUA for COVID-19 test with home sample collection

AppliedVR raises $29M as it seeks FDA clearance of VR system for pain treatment

Medtronic receives FDA approval for labelling of Intellis platform when using DTM SCS

GE Healthcare 2D/3D imaging system wins FDA nod

FDA grants EUA to COVID-19 screening device using machine learning

CMS delays Medicare coverage of breakthrough devices

A Major Turning Point for COVID-19-Related Diagnostics

FDA streamlines pathway to at-home asymptomatic COVID-19 test approval

Viz.ai Proves AI is Still ‘Relevant’ in Medtech with $71M Financing

FDA clears Catalyst OrthoScience reverse shoulder system

FDA seeks to ease path to COVID screening test nods

Abbott halts trial enrollment for HeartMate PHP catheter blood pump

PMA submission process initiated for FDA approval of Limiflex

Second Sight gains FDA nod for retinal system that may never be produced

ReFlow system mini receives FDA breakthrough device designation

With results of pivotal study, AppliedVR to seek FDA clearance

Icometrix announces ischaemic stroke solution

BrainStorm’s NurOwn does not have enough clinical data according to FDA

Bone-Stimulating Device Uses NASA-Developed Tech to Help Prevent Osteoporosis

FDA panel votes against BD Lutonix drug-coated balloon for below-the-knee

New FDA medtech cybersecurity chief: Guidance to debut in 2021

Cerus Endovascular neurovascular system wins FDA breakthrough device designation

Vascular Perfusion Solutions lands FDA breakthrough nod for organ-transport device

First daytime treatment for obstructive sleep apnea receives De Novo authorization

Johnson & Johnson applies for vaccine approval from FDA

Medtronic wins FDA approval for DiamondTemp ablation system

FDA Adds New Regulatory Science Tools for Assessing Medical Devices

Non-invasive PoNS device receives marketing authorisation from FDA 