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

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

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

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

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

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.

Artificial intelligence (AI) may need new oversight in some areas, but additional regulation of medical devices now would be ...

The US Food and Drug Administration (FDA) has granted 510(k) clearance for Mendaera’s Focalist, a handheld robotic system.

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

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 ...