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

FDA's plan to phase out animal testing may hurt Charles River's revenues. The DCF model suggests that CRL presents an ...

CytoSorbents Corporation (NASDAQ: CTSO), a leader in blood purification therapies for life-threatening conditions in the intensive care unit and cardiac surgery, today provided a regulatory update 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 ...

Endoscopy devices restricted from import accounted for about 1% of the company’s consolidated revenue in its latest fiscal ...

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

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 ...

The FDA’s clunky launch of Elsa, an AI tool to increase efficiency, has sparked concern from agency employees and outside ...

Olympus is promising swift action to address concerns raised by the Food and Drug Administration (FDA) about some of its ...

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

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