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

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

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

This clearance marks a significant advancement in glaucoma care, especially for earlier stages of the disease and across a wide spectrum of ...

Precision Neuroscience announced today that it received FDA 510(k) clearance for its Layer 7 cortical interface for BCI ...

The reduction in force at the FDA could worsen security and patient safety, witnesses said. Kevin Fu, who served as acting director of medical device security at the FDA’s Center for Devices and ...

FDA can take action if it believes the changes require a new marketing submission. The recent Warning Letter highlights a critical aspect of medical device regulation: while a device may initially ...

On Monday, March 31, a court in the Eastern District of Texas found unlawful and vacated the Food and Drug Administration’s ...

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 ...

“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 ...

Eva Temkin, a lawyer at Arnold & Porter who advises clients on drug and medical device applications, said even if product reviewers are not terminated in the next round of layoffs, other FDA staff ...