STAT1d
FDA pushes makers of AI devices to disclose more details on testing, performance
The FDA wants the developers of medical devices that rely on AI to disclose more detail about how their devices were ...
Hosted on MSN3h
A Win for AI in Cancer; 2025's Transformative Drugs; FDA Clarifies 'Underway' Trials
An AI system developed to predict a patient's response to immunotherapy could help "democratize" access to the pricey drugs ...
Demystifying AI
The agency wants applicants to demystify their algorithms and provide specific details about what the models do, how they’re ...
BioSpace3d
FDA’s New AI Guidance Highlights Risks of Technology, Urges Early Sponsor Engagement
The FDA’s guidance on AI in drug development points to potentially life-threatening consequences of the technology, highlighting the importance of providing the regulator with detailed information ...
Health care AI, intended to save money, turns out to require a lot of expensive humans
This is a KFF Health News story. Preparing cancer patients for difficult decisions is an oncologist's job. At the University ...
FDA aims to stem AI device bias, boost transparency in draft guidance
The document follows the agency’s first digital health advisory meeting and a final guidance on postmarket updates to AI ...
IBD 50's GeneDx Adds To Nearly 2,700% Sprint With FDA Guide On AI
Shares of the IBD 50's GeneDx surged Monday after the Food and Drug Administration issued guidance about using AI to develop ...