Vivos Inc. (OTCQB: RDGL), a pioneer in Precision Radionuclide TherapyTM (PRnT) solutions, today announced the submission of its Investigational Device Exemption (IDE) application to the U.S. Food and ...

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

The US FDA has cleared Intuitive's Vessel Sealer Curved for use with the company’s multiport da Vinci surgical systems.

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

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

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 ...

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

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

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 ...

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