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 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 ...

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 ...

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.

Califf completed his second term as FDA commissioner in January with the change in administrations. He’s only the second ...

The FDA has barred the import of multiple medical devices manufactured by Olympus Medical Systems and its subsidiaries in Japan, citing ongoing violations of federal quality system regulations.