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 ...

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

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

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

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

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 ...

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

Onward Medical submits two major regulatory applications for its ARC-EX system; seeking clearance to expand its indication for home use: Eindhoven, the Netherlands Thursday, July ...

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

Brazil is experiencing a regulatory revolution that is fundamentally transforming its medical device clinical trial landscape ...

The Supreme Court declined Monday to consider an appellate court’s 2023 decision overturning portions of an Oklahoma law regulating pharmacy benefit managers.