The FDA's breakthrough devices program helps the industry with faster review times, but the benefit to patients is unclear.

Generative AI chatbot for doctors called 'Prof. Valmed' earns E.U. approval. In the U.S., FDA is yet to issue guidelines on ...

The agency said it issued the import alerts because it “continues to have concerns related to outstanding Quality System ...

Onward Medical announced today that it submitted its ARC-EX system for expanded FDA indication and for CE mark approval.

Since 2016, the average number of medical AI device authorizations by the FDA per year has increased from two to 69, ...

Olympus announced recently that it is committed to addressing the concerns of the FDA around its device manufacturing in ...

ProPublica spent 14 months investigating the FDA’s oversight of foreign drugmakers that send medications to the U.S. These ...

FDA 510(k) application submitted to allow marketing of the ARC-EX® System for home use in the United StatesCE Mark ...

A new article in the Journal of the American Medical Association said the FDA will implement AI into multiple processes.

Oct. 16, 2024 — Before the FDA allows prescription medicines on the market, drugmakers must prove they’re safe and effective. What’s less widely known is that most medical devices ...