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

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 ...

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

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

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 ...

AirLife and Vyaire are recalling specific infant breathing support systems due to a potentially dangerous defect that could ...

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

The Minneapolis-based medtech company can now market its wearable sensor, eMotus, to hospitals and cancer centers.

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

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 ...