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

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

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

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

The Food and Drug Administration has published final guidance for the cybersecurity of premarket medical devices. The new ...

As devices come onto the market that have to follow the new FDA guidance of SBOMs and patching, backdoors may become easier to prevent and detect.

Generative AI chatbot for doctors called 'Prof. Valmed' earns E.U. approval. In the U.S., FDA is yet to issue guidelines on ...

Nearly two million people worldwide have lost the simple ability to feel steady. Now researchers have developed an ...

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

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

The past six months at the US Department of Health and Human Services and the US Food and Drug Administration’s Center for Devices and ...