2025 Year in Review: 295 AI/ML Medical Device Clearances Set New Record

The FDA's pace of AI/ML medical device clearances continued to accelerate in 2025, with 295 new clearances — a new annual record that brings the cumulative total of authorized AI-enabled medical devices past 1,200. The vast majority (97%) continue to come through the 510(k) pathway, though a growing number of novel applications are pursuing De Novo classification.

Radiology remains the dominant domain, but notable growth areas include cardiology, where AI-powered ECG analysis and cardiac imaging tools are proliferating, and pathology, where computational analysis of tissue slides is gaining clinical traction. Ophthalmology continues to be a strong category, building on the success of autonomous diabetic retinopathy screening.

A significant regulatory development occurred in January 2026, when the FDA published guidance reducing oversight of certain lower-risk digital health products, including some AI-enabled software and consumer wearables. The guidance clarified that tools where clinicians can independently review AI recommendations fall outside medical device regulation in many cases.

Notably absent from the approved landscape: no regulatory-approved radiology product yet leverages a generative LLM. Approved tools remain conventional, clinically-focused algorithms. However, the FDA's growing interest in labeling for devices with LLM components suggests 2026 may see the first such clearances.