The U.S. Food and Drug Administration (FDA) has added 178 new artificial intelligence (AI) and machine learning-enabled medical devices and software applications to a list of products that have been cleared by the agency.
This list was updated on October 5, and it includes products cleared through July 29, 2022. New products on the list range from dedicated software applications to medical devices that have built-in AI or machine-learning functionality.
The FDA is providing this list as a public resource and is in no way meant to be exhaustive or comprehensive, the agency noted. Instead, it is a list of devices across medical disciplines, based on publicly available information.
To view the full list, visit the FDA's website.
![A normal mammogram confirmed by three-year radiologic follow-up illustrates reader-marked regions of interest (ROIs) during (A) unaided (round 1) and (B) artificial intelligence (AI)–assisted (round 2) reading. Each colored dot represents an ROI for recall by a human reader. Readers could mark more than one ROI per case, represented by multiple dots of the same color. During AI-assisted reading, the AI system displayed three visible prompts: two with suspicion of malignancy scores of 35% (left mediolateral oblique [L MLO] and craniocaudal [L CC]) and one with a suspicion of malignancy score of 10% (right craniocaudal [R CC]), shown as polygonal overlays. Without AI, six of 10 readers (60%) marked a false-positive ROI. With AI assistance, this fell to two of 10 (20%). R MLO = right mediolateral oblique.](https://img.auntminnie.com/mindful/smg/workspaces/default/uploads/2026/07/2026-07-14-radiology-mammogram-ai-auto-bias.H0bYO8QlWs.jpg?auto=format%2Ccompress&dpr=2&fit=crop&h=167&q=70&w=250)
