The FDA Just Created a New Category of Violation: AI Over-Reliance
A drug manufacturer told federal inspectors the AI never told them about a basic legal requirement. The FDA was not amused.
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First Radiology Generative AI Gets FDA Breakthrough Designation
Cognita CXR drafts preliminary chest x-ray reports for radiologist review, with validation showing 16-65% detection improvements
FDA Approves First AI Imaging Device for Breast Cancer Surgery
Claire becomes the first AI-enabled system cleared to assess tumor margins during lumpectomy, potentially reducing repeat surgeries.
FDA Grants Breakthrough Status to Post-Surgery AI Chatbot
RecovryAI becomes the first generative AI medical device to receive FDA breakthrough designation, signaling how regulators may approach patient-facing chatbots.