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

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

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

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.

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

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

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

Federal authority to regulate cosmetics remained largely unchanged until, on December 29, 2022, President Biden signed the ...

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

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