Where Data Tells the Story
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The FDA has authorized 1,390 AI-enabled medical devices between 2016 and 2025, most of them through the 510(k) clearance pathway rather than full premarket approval. Annual clearances rose from 18 in 2016 to 333 in 2025, an 18.5-fold increase in a decade.
Radiology has captured the large majority of that growth in every single year. Its share peaked at 87% in 2020 and eased to 76% by 2025, but it never dropped below 59%, not even in 2017, before the growth accelerated. Cardiovascular devices, the next largest category, cleared 27 devices in 2025 versus radiology's 254.
The concentration likely reflects how well AI performs on standardized, high-volume image data, and possibly how the FDA compiles this particular list: devices are identified by AI-related terms in their submission summaries, a method that tends to catch imaging software more consistently than other specialties.
A decade of explosive growth in AI-cleared devices has not broadened where that AI actually lands. It has mostly gotten better at doing the same thing.
Source: FDA AI-Enabled Medical Devices List, current as of June 2026.