The U.S. Food and Drug Administration has announced the availability of its final guidance on AI medical devices. The document – Marketing Submission Recommendations for a Predetermined Change Control ...
The U.S. Food and Drug Administration (FDA) recently issued a Warning Letter citing a failure to obtain marketing authorization via a premarket approval (PMA) or 510(k) clearance as well as Good ...
Integrating AI into medical devices brings the industry a new level of innovation. The benefits can help both providers and patients but also introduce more risk. AI’s application in any technology is ...
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