Lexology October 20, 2025
ABSTRACT: This summer, FDA published a list of AI-Enabled Medical Devices as a resource to quickly identify AI-enabled medical devices authorized for marketing in the United States. As of September 30th, FDA is also seeking public comment on measuring and evaluating the performance of AI-enabled medical devices in the real-world. Will healthcare innovators, providers and/or patients begin using these devices more than non-AI-enabled medical devices? Will public comment help shape how FDA regulates and/or approves these devices? Time will tell, but as with other areas of AI, we anticipate exciting developments are on the horizon for medical devices.
This summer, FDA published an updated list of Artificial Intelligence (AI)-Enabled Medical Devices as a resource to quickly identify AI-enabled medical devices...
Today's Sponsors
Today's Sponsor