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 […]
The Food and Drug Administration is greenlighting AI tools at a faster pace, from computer […]
Genentech announced today that the FDA approved its supplemental biologics license application for the Xolair […]
A Covid-19 antibody cocktail developed by Regeneron Pharmaceuticals and Roche has pivotal clinical trial data […]
The FDA today declared that the recall of an emergency infusion device kit is the […]
The Food and Drug Administration has granted De Novo authorization to GI Genius, the first-of-its-kind […]
The FDA said today that is looking into the causes of infections from reprocessed urological […]
Helius Medical Technologies has announced that its Portable Neuromodulation Stimulator (PoNS) device, for multiple sclerosis sufferers, […]
Two brands of surgical mesh used off-label in breast reconstruction surgery have had “significantly higher […]
Bluestar Genomics announced today that it received FDA breakthrough device designation for its pancreatic cancer […]
B. Braun Interventional Systems (BIS) announced today that it is collaborating with Infraredx on a […]
The FDA has authorized a new device to help adults with mild to moderate […]
Dive Brief: FDA has authorized Helius Medical Technologies’ neuromodulation stimulator to improve the gait of multiple […]
On Thursday, Amazon landed an FDA Emergency Use Authorization for its COVID-19 test kit with […]
AppliedVR received a breakthrough device designation last year for its VR system for treating chronic […]
Medtronic has announced that the US Food and Drug Administration (FDA) has approved the revised […]
GE Healthcare has announced FDA 510(k) clearance for a new surgical imaging system capable […]
Dive Brief: FDA has granted emergency use authorization to a machine learning system designed to […]
Medicare coverage for FDA-designated breakthrough medical devices will have to wait, despite broad support. The […]
In a first for the industry, FDA has granted marketing authorization to a SARS-CoV-2 test […]
This week, the Food and Drug Administration shared that it will allow marketing for some COVID-19 screening […]
Viz.ai has raised $71 million in a series C round to expand its artificial intelligence […]
Catalyst OrthoScience today announced that it received FDA 510(k) clearance for its reverse shoulder system. […]
The FDA today published information to help developers of tests to screen asymptomatic people for […]
Dive Brief: Abbott Laboratories has suspended enrollment in its trial of the HeartMate PHP catheter […]
Empirical Spine, maker of the LimiFlex paraspinous tension band, has announced initiation of the PMA […]
Second Sight Medical (NSDQ: EYES) today announced that the FDA has approved its Argus 2s retinal […]
Anuncia has announced that it has received US Food and Drug Administration (FDA) breakthrough device designation […]
AppliedVR’s program includes a feature for users to go through guided breathing exercises, which are […]
In a press release, icometrix announced the addition of icobrain cva, a stroke solution, to the icobrain portfolio. According to […]
BrainStorm Cell Therapeutics announced it recently met with senior leadership from the US Food and Drug […]
After bone density peaks, typically when people reach their 30s, most experience a slow decline […]
An FDA advisory panel voted against a favorable recommendation for BD‘s Lutonix catheter-based, drug-coated balloon for […]
The FDA’s first medical device cybersecurity chief says he will work across private and public […]
Cerus Endovascular today said it has received FDA breakthrough device designation for its Contour Neurovascular System. […]
The FDA has granted startup Vascular Perfusion Solutions (San Antonio, Tex.) breakthrough device designation […]
The FDA has granted De Novo authorization to what will be the first device treatment […]
Johnson & Johnson (NYSE:JNJ) announced that it submitted an FDA emergency use authorization (EUA) application for […]
Medtronic (NYSE:MDT) announced today that it received FDA approval for its DiamondTemp ablation (DTA) system for […]
FDA recently added five tools to its catalog of regulatory science tools to help assess medical […]
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