The software can determine the extent and severity of coronary plaque build-up implicated in coronary artery disease.

Epredia has received 510(k) clearance from the FDA for the E1000 Dx, a scanner designed to streamline laboratory cancer ...

Nearly a third of medical device adverse events were not submitted to the FDA within a 30-day regulatory window, with most late reports filed more than six months after manufacturer notifications ...

Beginning Friday night, FDA employees overseeing medical devices and other key areas received calls and emails notifying them that their recent terminations had been “rescinded effective ...

Almost a third of medical device adverse events (AEs) were reported by manufacturers later than the US Food and Drug Administration’s (FDA) required 30-day window across a three-year period ...

Beginning Friday night, FDA employees overseeing medical devices and other key areas received calls and emails notifying them that their recent terminations had been “rescinded effective ...

Beginning Friday night, FDA employees overseeing medical devices, food ingredients and other key areas received calls and emails notifying them that their recent terminations had been “rescinded ...

FDA Moves to Rehire Medical Device, Food Safety and Other Staffers Fired Days Earlier WASHINGTON (AP) — Barely a week after mass firings at the Food and Drug Administration, some probationary ...