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.

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 ...

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

Globally, generative artificial intelligence (Gen AI) and agentic AI are increasingly being integrated into medical devices, transforming both clinical workflows and patient care. Gen AI is primarily ...

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

Vivian Health reports AI is revolutionizing medical imaging, enhancing speed, accuracy, and patient care through advanced ...

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

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 ...

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