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.

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

The FDA has issued its much-anticipated final guidance on cybersecurity risk management in medical devices, effective June ...

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

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

The FDA’s clunky launch of Elsa, an AI tool to increase efficiency, has sparked concern from agency employees and outside ...

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

Despite America's health policy turmoil, a number of ASX biotechs have announced big progress on their US expansion plans.

Olympus announced recently that it is committed to addressing the concerns of the FDA around its device manufacturing in ...