The US Food and Drug Administration has now authorized 1,614 medical devices that use AI, according to its latest public list, which runs to the end of June 2026. Of those, 1,230, or 76 percent, are in radiology.
The share shows where medical AI has actually been cleared for use. All other fields of medicine together account for fewer than 400 devices.
The last quarter
In the second quarter of 2026 the FDA added 89 devices to the list, 66 of them in radiology. That is 74 percent, close to the long-term share, according to a count by the trade newsletter The Imaging Wire.
The biggest names on the list are scanner makers, not AI startups. GE HealthCare leads with 134 devices, followed by Siemens Healthineers with 101 and Philips with 62. The largest companies built only around AI are Aidoc with 34 and DeepHealth with 32.
What the list does not count
The FDA warns that the list is not complete. It finds devices mainly by searching for AI-related terms in public summaries. A device that does not describe itself that way can be missing.
The agency also has no tag yet for devices built on large language models or other foundation models. It says it will look for ways to identify them and asks companies to mention such features in their public summaries. For now, nobody can count them from the list.
