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 ...

Is AI the solution to America’s glacial drug approval process, or a Pandora’s box for public health? That’s the question ...

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

While the FDA is responsible for regulating both drugs and devices, they’re handled through completely different processes in different parts of the agency. In fact, the FDA’s definition of a ...

The FDA is notifying healthcare providers about import alerts for certain medical devices manufactured in Japan by Olympus.

The Food and Drug Administration has published final guidance for the cybersecurity of premarket medical devices. The new ...

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 ...

The Food and Drug Administration is urging medical product makers to carefully address the cybersecurity of their connected ...

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

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