FDA Archives - Page 7 of 15 - TMG Pulse

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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 […]

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AI FDA MedTech

FDA Releases Artificial Intelligence/Machine Learning Action Plan

Today, the U.S. Food and Drug Administration released the agency’s first Artificial Intelligence/Machine Learning (AI/ML)-Based Software […]

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FDA MedTech

5 innovations to make duodenoscopes more single-use — and save lives

Duodenoscopes are important medical devices that are used for endoscopic retrograde cholangiopancreatography (ERCP) procedures. […]

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CE Mark FDA Neuro

Boston Sci Wins Nod for 4th Gen. Vercise Genus DBS

Boston Scientific won a nod from FDA for its fourth-generation Vercise Genus Deep Brain Stimulation […]

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Cardiology FDA MedTech

FDA breakthrough nods go to Alzheimer’s devices, cardiovascular products

FDA has granted breakthrough status to two medical devices aimed at Alzheimer’s disease patients in […]

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Diagnostics FDA

PerkinElmer Wins EUA to Test Asymptomatic People

PerkinElmer is targeting asymptomatic people in its latest testing offering for COVID-19 testing. The Waltham, […]

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FDA MedTech

Medicare to cover breakthrough devices

FDA-designated breakthrough devices will have Medicare coverage the same day they are approved, under a […]

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AI FDA MedTech

FDA debuts plan for AI-based Software as a Medical Device

The FDA today released its first plan to regulate artificial intelligence/machine learning (AI/ML)-based Software as […]

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AI FDA MedTech

FDA issues action plan for regulating AI in medical devices

Dive Brief: FDA on Tuesday released an action plan for establishing a regulatory approach to the […]

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Biotech Diagnostics FDA

FDA grants EUA for RapCov rapid COVID-19 antibody test

Advaite announced today that it received FDA emergency use authorization for its RapCov point-of-care COVID-19 antibody […]

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AI FDA

FDA debuts plan for AI-based Software as a Medical Device

The FDA today released its first plan to regulate artificial intelligence/machine learning (AI/ML)-based Software as […]

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FDA MedTech

FDA takes ‘STeP’ toward safer devices

The FDA has released final guidance for a new, voluntary review process that would streamline […]

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Digital Health FDA Patient Monitoring

After 2020, telehealth use accelerates from ‘digital PPE’ toward mainstream care

The promise of a digital revolution in healthcare has been described as “just a few […]

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Cardiology FDA Imaging

Genetesis wins FDA breakthrough nod for imaging tech

Cardiac imaging technology developer Genetesis announced today that its flagship product received FDA breakthrough device designation. Mason, […]

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Cardiology FDA MedTech

ReCor Medical gains FDA breakthrough nod for renal denervation system

ReCor Medical this week announced that its Paradise Ultrasound Renal Denervation System won FDA breakthrough device […]

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FDA Implantables Orthopedic

Ensemble Orthopedics gains FDA clearance for hand implant

Ensemble Orthopedics recently announced said it received FDA 510(k) clearance for its Ensemble CMC Implant. […]

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FDA Funding Neuro

BrainsGate raises $14M

Ischemic stroke treatment developer BrainsGate announced today that it secured a $14 million investment to fund future […]

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Cardiology FDA Implantables

Vectorious’ in-heart microcomputer wins FDA breakthrough nod

Vectorious Medical Technologies today announced that the FDA has granted breakthrough device designation for the company’s […]

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Biotech FDA Pharmaceutical

BREAKING: Pfizer, BioNTech submit FDA EUA request for COVID-19 vaccine

Pfizer (NYSE:PFE) and its partner BioNTech (NSDQ:BNTX) announced that they will submit a request today with […]

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Topic: FDA

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

FDA Releases Artificial Intelligence/Machine Learning Action Plan

5 innovations to make duodenoscopes more single-use — and save lives

Boston Sci Wins Nod for 4th Gen. Vercise Genus DBS

FDA breakthrough nods go to Alzheimer’s devices, cardiovascular products

PerkinElmer Wins EUA to Test Asymptomatic People

Medicare to cover breakthrough devices

FDA debuts plan for AI-based Software as a Medical Device

FDA issues action plan for regulating AI in medical devices

FDA grants EUA for RapCov rapid COVID-19 antibody test

FDA debuts plan for AI-based Software as a Medical Device

FDA takes ‘STeP’ toward safer devices

After 2020, telehealth use accelerates from ‘digital PPE’ toward mainstream care

Genetesis wins FDA breakthrough nod for imaging tech

ReCor Medical gains FDA breakthrough nod for renal denervation system

Ensemble Orthopedics gains FDA clearance for hand implant

BrainsGate raises $14M

Vectorious’ in-heart microcomputer wins FDA breakthrough nod

BREAKING: Pfizer, BioNTech submit FDA EUA request for COVID-19 vaccine