The rise of AI in health care presents new challenges related to the patentability and regulation of AI-driven medical technologies. This article examines the 2024 guidelines from the U.S. Patent and ...

The draft is a near total overhaul of the document finalized by FDA in 2005, with only short sections on topics such as software verification and the history of software revisions surviving unchanged.

The number of medical devices with artificial intelligence technology has risen sharply in the past decade. The Food and Drug Administration has authorized 950 AI or machine learning-enabled devices ...

The International Medical Device Regulators Forum (IMDRF) has issued a draft guidance for predetermined change control plans ...

About the Author: Bradley Merrill Thompson is a member of the firm at Epstein Becker & Green, P.C. There, he counsels medical device, drug, and combination product companies on a wide range of FDA ...

Expertise from Forbes Councils members, operated under license. Opinions expressed are those of the author. Medical device cybersecurity is a dynamic and evolving space. As more devices enter the ...

Nurea, a pioneer in AI-powered medical imaging, today announced that its PRAEVAorta®2 software has received FDA 510(k) ...