The U.S. Food and Drug Administration (FDA) is seeking comments on methods of assessing the real-world performance of AI-enabled medical devices, including generative AI. Prior FDA draft guidance has ...
Wearable health devices now track heart health, stress, glucose, fertility, and sleep, turning smart wearables into everyday ...
Kimberlee Leonard has 22 years of experience as a freelance writer. Her work has been featured on US News and World Report, Business.com and Fit Small Business. She brings practical experience as a ...
On January 6, 2024, FDA released draft guidance on Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations (the “draft guidance”). The ...
Some results have been hidden because they may be inaccessible to you
Show inaccessible results
Feedback