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.