ONWARD ARC-EX System for spinal cord injury is now available for purchase through VA Federal Supply Schedule and GSA Advantage ...

ONWARD ARC-EX System for spinal cord injury is now available for purchase through VA Federal Supply Schedule and GSA Advantage platforms Partnership with Lovell Government Services is providing commer ...

Allogene Therapeutics (ALLO) announced that the U.S. Food and Drug Administration, FDA, has cleared its Investigational New Drug, IND, ...

Brenner replaces Dr. Robert Califf. The announcement was made quietly via an update made online to the FDA’s leadership bio page. As of Jan. 24 Brenner’s biography had not been added to the page.

As part of its enforcement activities, the Food and Drug Administration (FDA) sends warning letters to entities under its jurisdiction. Some letters are not posted for public view until weeks or ...

Follow live updates and news coverage of the Senate confirmation hearing for RFK Jr. Stay up to date with real-time developments on key moments and outcomes for Trump’s nominee for Health Secretary.

News-Medical speaks with Jordi Labs’ about its recent achievements, alignment with FDA expectations, and strategic ...

AI Optics Inc., an AI-focused medical device company announced today that it has received FDA 510(k) clearance for its Sentinel Camera. This handheld retinal imaging system captures high-quality ...

Gen.2 Molarity assay has received 510(k) clearance from the United States Food and Drug Administration (FDA). This will be the first 510(k) cleared test of its kind available in the U.S. measuring ...

Logo Myocene MYOCENE kicks off the first FDA De Novo clearance of 2025 for its groundbreaking muscle fatigue monitoring device. LIèGE, ...

Lynx, Norlase’s pattern scanning laser indirect ophthalmoscope, commercially launched with both FDA 510(k) clearance and a CE ...