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

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

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

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

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

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.

U.S. medical device regulations require manufacturers of most class II and a small number of class I devices to file a 510 (k) unless they qualify for an exemption. 510 (k) is a premarket technical ...

ENSCHEDE, NL / ACCESS Newswire / January 28, 2025 / Resyca BV, a pioneering leader in the development and manufacturing of advanced inhalation drug delivery devices, proudly announces successful ...

In 2023, the Food and Drug Administration (FDA) took a more active approach to medical device cybersecurity. They issued new requirements for premarket submission and ongoing monitoring by medical ...

The FDA considers devices approved through this “501 (k) pathway” to be moderate risk. The other 29%, seen as high-risk, followed a different pathway requiring clinical trials.

A five-point plan of action introduced by the FDA in 2021 for the regulation of machine learning and AI-based medical devices aims to foster innovation while ensuring the effectiveness and safety ...