The question is not whether AI will transform healthcare; it’s whether regulators can keep pace with that transformation.

Adagio Medical (Nasdaq:ADGM) announced today that it received FDA breakthrough device designation for its vCLAS cryoablation ...

The rise of AI in health care presents new challenges related to the patentability and regulation of AI-driven medical ...

According to the FDA’s public database, since the start of this year, the agency has issued only two de novo medical device clearances. That includes the Jan. 17 green light of Myocene’s ...

In another rebuke to federal regulatory overreach, the U.S. District Court for the Eastern District of Texas (“District Court”) has vacated the ...

A disease detection chatbot powered by generative AI and four cancer tests are among the latest medical devices to receive “breakthrough” status from the Food and Drug Administration.

The Food and Drug Administration on Thursday cleared a core component of a brain implant made by Precision Neuroscience, a ...

On March 31, 2025, the Eastern District of Texas issued a decision in the case brought by the American Clinical Laboratory Association (ACLA) and ...

“The real barriers to market entry for Indian medical device manufacturers lie not in tariffs, but in non-tariff barriers such as exorbitant US FDA registration fees and the requirement for ...

NEW YORK, March 25, 2025--(BUSINESS WIRE)--Powerful Medical ... has been granted Breakthrough Device Designation by the US Food and Drug Administration (FDA). This designation recognizes PMcardio ...