Globally, generative artificial intelligence (Gen AI) and agentic AI are increasingly being integrated into medical devices, ...

The FDA's breakthrough devices program helps the industry with faster review times, but the benefit to patients is unclear.

"FDA approves Dymicron’s study of cervical artificial disc" was originally created and published by Medical Device Network, a ...

The company completed a clinical trial at nine centers across the U.S., Europe and Asia before it received FDA approval.

Using recalled AirLife Infant Heated Wire Circuits could cause cause carbon dioxide build up in the blood, a lack of oxygen ...

U.S. physicians are losing trust in the FDA and CDC, presenting a new challenge — and opportunity — for device developers and ...

Synchrony Medical announced that it received FDA 510 (k) clearance for its LibAirty airway clearance system.

The FDA’s clunky launch of Elsa, an AI tool to increase efficiency, has sparked concern from agency employees and outside ...

The FDA has granted 510(k) clearance to the TaviPilot AI software developed by Caranx Medical, according to company officials ...

Joseph Jeanmarie dealt with the pain, mostly working at a pain level of eight out of 10. Now, new technology his helping him get his life back.

Medical device recalls are essential to patient safety, addressing critical issues in devices that may pose health risks. Here are some of the latest recalls reported to the FDA: Airlife and Vyaire ...