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.

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 ...

The new director at the FDA overseeing medical devices will confront criticisms about hasty approvals as she ushers in ...

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 this approval, Aucatzyl enters a market that includes Gilead’s Tecartus, which gained FDA approval for B-ALL in 2021.

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.

“Receiving FDA ... Medical Association’s approval of new CPT codes for totally implantable active middle ear implants, which opens new opportunities for our already FDA-approved Esteem® device.