If you want to own a piece of healthcare AI, start with a fact that most stock lists skip: the companies building the cleared products are overwhelmingly private. You cannot buy them. Not yet, and in many cases not ever, because they get acquired before they list.
As of 28 September 2026, 127 different companies hold at least one FDA clearance for an AI product in US healthcare, across 293 cleared products. 72 of those companies hold exactly one. The most recent clearance in the directory landed on 12 September 2026. You can see every one of them in the FDA-cleared directory.
We tested how much that list overlaps with the public markets by comparing every company name in the federal clearance record against the SEC's own register of listed companies, matching on exact legal name only. Exactly one came back. That number is too clean to take at face value, and the reason it is so low is interesting on its own.
Why the Two Lists Barely Touch
Three things pull them apart, and none of them is a conspiracy.
- Companies file under names they do not trade under. RapidAI's clearances sit under iSchemaview, its earlier corporate name. A large group's clearance may be filed by a national subsidiary. So a name-to-name comparison undercounts the public side badly, which is exactly why this site refuses to guess at the link.
- The buyers are public, the builders are not. The large imaging and diagnostics companies you find on any AI healthcare stock list mostly acquired or partnered their way in. The clearance often stays with the smaller entity that earned it.
- Most of these companies are venture-backed and still private. Look at the long tail below: a large share of the companies in the federal record hold exactly one cleared product. That is a young company with one thing that works, not a listed business.
Who Holds the Most Cleared AI
This is the concentration that matters, and it is measurable. A handful of companies hold a large share of every AI clearance granted in US healthcare.
| Company, as the FDA record names it | Cleared products | Share of all cleared AI |
|---|---|---|
| Aidoc Medical , Ltd. | 30 | 10.2% |
| Ischemaview, Inc. | 10 | 3.4% |
| Viz. Ai, Inc. | 7 | 2.4% |
| Avicenna.Ai | 7 | 2.4% |
| Screenpoint Medical B.V. | 7 | 2.4% |
| Ever Fortune.Ai, Co., Ltd. | 7 | 2.4% |
| Brainomix Limited | 6 | 2% |
| Hologic, Inc. | 6 | 2% |
| Cosmo Artificial Intelligence - Ai, Ltd. | 6 | 2% |
| DeepHealth, Inc. | 6 | 2% |
| Lunit, Inc. | 6 | 2% |
| Annalise-Ai Pty , Ltd. | 6 | 2% |
| Zebra Medical Vision, Ltd. | 6 | 2% |
| Siemens Medical Solutions USA, Inc. | 5 | 1.7% |
| Therapixel | 5 | 1.7% |
| Anumana, Inc. | 4 | 1.4% |
| Koios Medical, Inc. | 4 | 1.4% |
| Magentiq Eye, Ltd. | 4 | 1.4% |
| Iterative Scopes, Inc. | 4 | 1.4% |
| Icad, Inc. | 4 | 1.4% |
What an AI Healthcare ETF Actually Holds
The label is looser than it sounds. A fund sold on healthcare AI generally holds large, established healthcare and technology companies where AI is one product line among many, because those are the companies liquid enough for a fund to hold.
That is not a criticism of the funds. It is a description of what is available to buy. But it does mean the exposure you get is mostly to big healthcare businesses that also do AI, rather than to the cleared-product companies in the table above.
A Better Question Than Which Stock
If you are trying to understand this market rather than trade it, the clearance record is the most honest scoreboard available. It shows who got something through a regulator, what that product is permitted to claim, and when. It is slow, it is public, and nobody can spin it.
Start with the cleared directory to see who holds what, the company market map for profiles of the larger names, and the economic evidence report for whether any of it is paying for itself yet.