FDA Archives - TMG Pulse

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FDA M&A MedTech

Medtech in a Minute: Endologix Has a Breakthrough, and More

The biggest medtech news of the week, in one minute or less.

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FDA MedTech Pain Management

Neuros Medical gains FDA Breakthrough Device designation for Altius nerve block system

Neuros Medical has received Breakthrough Device designation from the US Food and Drug Administration (FDA) […]

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FDA Ophthalmology Pharmaceutical

FDA accepts biologics license application for Genentech’s drug-eluting eye implant

Genentech announced that the FDA accepted its Biologics License Application (BLA) for its Port Delivery […]

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FDA FDA Cleared MedTech

CoreLink announces FDA clearance for F3D Corpectomy Vertebral Body Replacement System

CoreLink has announced the commercial launch and 510(k) clearance from the US Food and Drug […]

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CE Mark FDA MedTech

Neo Medical lands FDA approval and CE certification for Pedicle Screw System

Neo Medical has received US Food and Drug Administration (FDA) 510(k) clearance for the use […]

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CE Mark FDA Spine

Spinal Stabilization Technologies receives CE Mark and FDA breakthrough designation for PerQdisc Nucleus Replacement System

Spinal Stabilization Technologies (SST) has announced that it has earned the CE Mark and the […]

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FDA FDA Cleared Spine

ChoiceSpine announces FDA clearance and clinical use of Blackhawk Ti Cervical Spacer System

ChoiceSpine, a spinal device company based in Knoxville, USA, has announced that it has received […]

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Cardiology FDA Structural Heart

Varian wins FDA breakthrough nod for cardiac radioablation system

Varian announced today that it received FDA breakthrough device designation for its cardiac radioablation (CRA) system. […]

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Digital Health FDA Women's Health

Digital chatbot Woebot lands FDA breakthrough designation to tackle postpartum depression

Digital mental health company Woebot Health has landed FDA Breakthrough Device Designation for its postpartum […]

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FDA Spine Surgery

CUREXO expands global reach after its spinal surgery robot acquires FDA licensing

South Korean medical robotics company CUREXO has announced that its spinal surgery robot, CUVIS-spine, has […]

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FDA MedTech Neuro

FDA issues draft clinical trial guidelines for neurostim, other devices to treat diabetes

The FDA today issued a draft guidance with recommendations for clinical trials for certain devices […]

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FDA MedTech

CMS delays Medicare payments for breakthrough devices until December

Medicare coverage for FDA-designated breakthrough medical devices will have to wait several more months, despite […]

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FDA MedTech Pharmaceutical

Neurodon prepping IND application for type 1 diabetes treatment

Neurodon announced today that it initiated studies to prepare an FDA Investigational New Drug (IND) […]

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FDA FDA Cleared MedTech

Bigfoot Biomedical wins FDA clearance for smart insulin pen cap system

Bigfoot Biomedical announced today that it received FDA 510(k) clearance for its Bigfoot Unity diabetes […]

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FDA MedTech Neuro

IpsiHand System: New device for facilitating stroke rehabilitation gains FDA approval

The US Food and Drug Administration (FDA) has authorised marketing of a new device indicated […]

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FDA Neuro Vascular

Cerus Endovascular announces Contour Neurovascular System™ IDE trial approval

Cerus Endovascular has announced that the US. Food and Drug Administration (FDA) has approved its […]

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FDA MedTech Neuro

Neurolutions Receives U.S. Food and Drug Administration De Novo Market Authorization for IpsiHand™ Upper Extremity Rehabilitation System

IpsiHand exoskeleton uniquely leverages brain-computer interface technology for chronic stroke rehabilitation IpsiHand also has been granted […]

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FDA MedTech Patient Monitoring

BD applies to start shipping Alaris pumps again

BD (NYSE:BDX) said today that it has applied to the FDA for a new clearance […]

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FDA MedTech

Intertek gains FDA nod for premarket device testing

Intertek has won accreditation under an FDA pilot program for testing laboratories, the company said […]

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FDA MedTech Neuro

FDA approves application for phase I study of MLC1501 programme in post-traumatic brain injury recovery

Moleac has announced the approval of the US Food and Drug Administration (FDA) of an […]

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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 […]

Topic: FDA

Medtech in a Minute: Endologix Has a Breakthrough, and More

Neuros Medical gains FDA Breakthrough Device designation for Altius nerve block system

FDA accepts biologics license application for Genentech’s drug-eluting eye implant

CoreLink announces FDA clearance for F3D Corpectomy Vertebral Body Replacement System

Neo Medical lands FDA approval and CE certification for Pedicle Screw System

Spinal Stabilization Technologies receives CE Mark and FDA breakthrough designation for PerQdisc Nucleus Replacement System

ChoiceSpine announces FDA clearance and clinical use of Blackhawk Ti Cervical Spacer System

Varian wins FDA breakthrough nod for cardiac radioablation system

Digital chatbot Woebot lands FDA breakthrough designation to tackle postpartum depression

CUREXO expands global reach after its spinal surgery robot acquires FDA licensing

FDA issues draft clinical trial guidelines for neurostim, other devices to treat diabetes

CMS delays Medicare payments for breakthrough devices until December

Neurodon prepping IND application for type 1 diabetes treatment

Bigfoot Biomedical wins FDA clearance for smart insulin pen cap system

IpsiHand System: New device for facilitating stroke rehabilitation gains FDA approval

Cerus Endovascular announces Contour Neurovascular System™ IDE trial approval

Neurolutions Receives U.S. Food and Drug Administration De Novo Market Authorization for IpsiHand™ Upper Extremity Rehabilitation System

BD applies to start shipping Alaris pumps again

Intertek gains FDA nod for premarket device testing

FDA approves application for phase I study of MLC1501 programme in post-traumatic brain injury recovery

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

Non-invasive PoNS device receives marketing authorisation from FDA 