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

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

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

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

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

Switzerland-based Medimaps has launched a new version of its artificial intelligence (AI)-based image processing software for osteoporosis assessment in Europe.

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

The FDA is shutting the door to imports of certain endoscope hardware manufactured by Olympus, saying that a production site ...

Over the past decade, health insurance companies have increasingly embraced the use of artificial intelligence algorithms.

Vinay Prasad—the controversial head of vaccine regulation at the US Food and Drug Administration (FDA)—has been named FDA chief medical and scientific officer.1 Traditionally separate roles, his new ...

Health insurance companies use AI to decide which health care treatment to cover. State laws and federal agencies are now ...

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