The FDA designated 166 products under its breakthrough devices program in its most recent financial year, reversing the ...

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

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

GE HealthCare on Wednesday said U.S. regulators had cleared its head-only magnetic resonance imaging scanner.

Robert F. Kennedy Jr., one of President-elect Donald J. Trump’s advisers on health, is taking aim at the agency’s oversight ...

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 marked by a rapid approval process for medical devices ...

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) -- ...

IPL and at-home laser removal machines that actually work, for every skin tone (including dark) and hair color, face, ...

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

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.