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

One of the co-founders of Elon Musk’s Neuralink Corp. is building a different kind of brain implant. That device, made by the startup Precision Neuroscience Corp., went in 63-year-old Tim Fisher ...

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

Nasdaq Listing Rule 5550 (a) (2) requires listed securities to maintain a minimum bid price of US$1.00 per share, and Nasdaq Listing Rule 5810 (c) (3) (A) provides that a failure to meet the minimum ...

A device in clinical development appears to be far safer and more effective than the TAVI devices currently being used ...

SeaStar Medical Holding Corporation (Nasdaq: ICU), a commercial-stage healthcare company focused on transforming treatments for critically ill patients facing organ failure and potential ...

While pharmaceutical companies are safe for the time being from country-specific reciprocal tariffs announced by President Trump Wednesday, medical devices are not. That's according to The ...

2 Clinical or non-clinical data and chemistry and manufacturing data Submissions based on clinical or non-clinical data and chemistry and manufacturing data for a drug that does not include a new ...

The U.S. Food and Drug Administration has determined a recall of certain packs of Coca-Cola should be classified as a Class II Recall. The classification followed a original voluntary recall of ...

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 ...

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.

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 ...