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- FDA releases discussion paper seeking input on regulation of generative AI medical devicesThe U.S. Food and Drug Administration issued a discussion paper outlining considerations for regulating generative AI-enabled medical devices and asked stakeholders to provide feedback. The paper…
- Amylyx reports Phase 3 success for avexitide in post-bariatric hypoglycemiaAmylyx announced a late-stage success for avexitide, a GLP-1 receptor antagonist, in a Phase 3 trial targeting post-bariatric hypoglycemia. The trial results showed the drug achieved its primary e…