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 ...

Reports on medical device adverse events widely exceed FDA deadlines, according to a recent study published in the BMJ. Read ...

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medical devices and other key areas received calls and emails notifying them that their recent terminations had been “rescinded effective ...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 ...

Lungpacer Medical announced that it received FDA investigational device exemption (IDE) approval to begin a trial for its ...

Ross Segan, who was formerly the director of the Office of Product Evaluation and Quality at the FDA’s medical device center, was one of thousands of employees fired across the US Department of ...

Nearly half of the FDA’s $6.9 billion budget comes from fees paid by companies the agency regulates, including drug and medical device makers, which allows the agency to hire extra scientists to ...

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food ingredients and other key areas received calls and emails notifying them that their recent terminations had been “rescinded ...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 ...