Authorized is not proven: what the FDA's AI device list does and doesn't tell you

If you want to see where AI actually works in health, don't look at chatbots. Look at scans.

The US FDA keeps a list of AI-enabled medical devices. When I counted the list on the FDA's page on 22 October 2026, it had 1,614 entries, the latest decided on 29 June 2026, and 1,230 of them (about 76%) were listed under radiology. That is my own count of the published table, so check it against the page before you repeat it.

Reading the fine print

• The list includes hardware with AI inside, not only software.
• The FDA says on its own page that the list is not comprehensive: devices were identified mainly by AI-related terms in their authorization summaries.
• It counts authorizations. It does not count whether patients got better.

So "authorized" is a statement about a regulatory process. It is not the same as "proven to improve outcomes in a real clinic".

The evidence gap, from England

NICE has put some imaging-adjacent tools in an "early-use" category: promising, but keep collecting evidence. A June 2026 summary reports four AI echocardiography tools there, with evidence not yet strong enough for routine funding. That is the same field, seen through a different gate.

Questions I'd ask of any imaging AI

These are my questions, not findings:

1. Tested at how many sites, and do they look like mine?
2. Compared against what baseline: a radiologist alone, or a radiologist with the tool?
3. Is there any data on outcomes, not just detection?
4. What happens when it disagrees with the human?

What I chose not to build

Tabibu does not read X-ray, CT or MRI images, or photos of skin. If you upload one, it says so. Interpreting those is a medical-device question, and I would rather say "I can't" than guess. What it does handle is a radiology report: it explains the report by quoting what the radiologist wrote. In my testing, radiology reports sometimes end on a safe fallback instead of a full explanation, about 1 in 8.

The field is real, regulated and growing, and the question is moving from "does it work in a lab" to "does it improve care in a real clinic". Would you want an AI to read your scan, with a radiologist checking?

I post short videos in this series on LinkedIn and TikTok; come say hi.

General information, not medical advice.