Over the past decade, FDA approvals of artificial intelligence and machine learning (AI/ML)–enabled medical devices have surged. They reached a ...

FDA regulations categorize medical devices into three classes, with varying levels of control to manage risks and ensure the safety of medical technologies.

The Chicago-based medical technology company said the MRI device, called Signa Magnus, had received 510(k) clearance by the U.S. Food and Drug Administration. That approval pathway is for devices that ...

As the FDA continues to develop and solidify its guidance and regulations on AI, medical device manufacturers should prepare ...

Michelle Tarver, MD, PhD, a 15-year veteran of the agency, is stepping into a pivotal role as the new director of the FDA's device division, taking over for Jeffrey Shuren, MD. Dr. Shuren's tenure was ...

Dr. Michelle Tarver, a veteran of the Food and Drug Administration (FDA), has taken charge of the FDA’s device division at a ...

Envoy Medical (COCH) announces that its Investigational Device Exemption, IDE, application for its pivotal study of the Acclaim Fully Implanted ...

This represents the fourth indication granted a Breakthrough Device Designation for the SCD by FDADENVER, Nov. 06, 2024 (GLOBE NEWSWIRE) -- ...

With FDA approval of an investigational device exemption, J&J’s soft tissue robot moves a step closer to challenging ...

Nov. 4, 2024 /PRNewswire/ -- Akura Medical, a Shifamed portfolio ... today the US Food and Drug Administration has approved its Investigational Device Exemption (IDE) application to initiate ...

Envoy Medical ... Device Exemption, IDE, application for its pivotal study of the Acclaim Fully Implanted Cochlear Implant has been approved by the U.S. Food and Drug Administration, FDA.