MINNEAPOLIS — U.S. Food and Drug Administration approvals of life-changing, high-risk medical devices reportedly slowed to a ...

HHS Secretary Robert F. Kennedy Jr.’s sweeping layoffs across federal health agencies are disrupting the work of drug, ...

The cuts to the FDA are just one piece of the budget proposal, which looks to slash the HHS’ discretionary spending by ...

The Trump administration’s recent announcement that it plans to eliminate about 3,500 FDA jobs is creating uncertainty among ...

Alibaba Group's Damo Academy has received FDA endorsement for its AI-powered cancer detection tool, marking a significant ...

Sequana Medical announced today that CMS recommended that its Alfapump system become eligible for a new incremental payment.

FDA has also been proactive in approving AI-driven medical devices, with more than 1,000 AI containing products authorized through established premarket pathways. These approvals reflect the ...

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

The results of the study will be used to apply for FDA premarket approval (PMA ... Adagio is a medical device company focused on developing and commercializing products for the treatment of ...

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

Get Instant Summarized Text (Gist) The FDA's approval of high-risk medical devices has reached a 10-year low, attributed to significant workforce reductions. Despite an increase in pending ...

Adagio Medical Holdings, Inc. (Nasdaq: ADGM) ("Adagio" or "the Company"), a leading innovator in catheter ablation technologies for the treatment of cardiac arrhythmias, today announced that it has ...