FDA cleared healthcare AI: 87 of 554 vendors hold a United States clearance or authorisation

Five words get used interchangeably in vendor marketing and mean five different things at the regulator. A 510(k) clearance means the FDA found a device substantially equivalent to a predicate for a stated intended use. A De Novo authorisation means no predicate existed, the agency reviewed the evidence directly, and a new device classification was created for later entrants to clear into. Premarket approval is the pathway for higher risk devices and companion diagnostics and involves clinical evidence rather than a predicate comparison. An Emergency Use Authorization is a temporary permission tied to a declared emergency. A Predetermined Change Control Plan is an agreed envelope of future modification a cleared model may move within without a new submission.

All five appear on the cleared list. What does not appear on it, and is filed separately further down, is everything that resembles a clearance and is not one. Breakthrough Device designation is a commitment to an expedited review of a device that has not been authorised. Establishment registration and device listing record that a firm exists and what it lists, involve no review of safety or effectiveness, and the agency itself states that using registration to suggest endorsement is improper. A CE mark, a UKCA mark or a Korean MFDS approval is real regulatory authorisation in another jurisdiction and does not license clinical use in the United States. A laboratory developed test reaches patients under clinical laboratory certification rather than device review.

Method

Every vendor in the AI Health Index carries a grade on FDA and Regulatory Status with a written note recording what was located in public sources. This census reads all 554 of those notes and files each vendor that evidences a specific regulatory position. A line here restates the vendor's own note; nothing was researched fresh for this page, which is why every line links to the record it came from.

Documented against vendor stated

72 entries cite a submission number, a decision date, a public regulatory register or a published indication for use. 15 entries record that the vendor states a clearance and no number was retrieved. Both are on the list because a stated clearance is a specific, checkable claim, but the tier is printed so a reader knows which lines can be verified in the public device database without asking anyone.

AI scope against device scope

11 of the 87 evidence a clearance that covers hardware, a data platform or a rule based function while the machine learning the index grades is outside the cleared indication. Those are marked device scope in the roster and the caveat says what is and is not inside the clearance. A cleared sensor feeding an uncleared early warning score is the commonest shape.

Dates

Grades on the FDA axis were last regenerated on August 31, 2026. This census was compiled on September 4, 2026. Records carrying clearance status are re reviewed every ninety days under the index methodology, and the public device databases remain the authoritative source for what is currently authorised, because a clearance can be superseded by a later submission the marketing has not caught up with.

87 of 554 vendors, 16 percent of the index. The pathway split shows what kind of regulatory work the market has actually done: overwhelmingly 510(k) clearances against predicates, a small set of De Novo authorisations that created the categories those predicates now sit in, and a handful of premarket approvals in genomic diagnostics where the assay rather than the model is the approved object.

By category, counting a vendor wherever it is listed rather than only under its primary heading, because that is how the category pages count. The share column is the fraction of a category's roster holding a United States clearance or authorisation. Read the low shares in clinical decision support and clinical trials for what they are: those categories are large and mostly unregulated, and the cleared members are imaging and diagnostics vendors cross listed into them.

Two absences are worth stating because the search that leads here often expects them to be present. No ambient scribe, autonomous coding, revenue cycle, prior authorisation, credentialing or administrative automation vendor in the index holds a United States device clearance, and none is required to, since documentation and billing are administrative acts. And no drug discovery vendor holds one either, because a drug programme is regulated as a drug: the instruments that apply there, investigational new drug clearance and Fast Track or Orphan Drug designation, are listed in their own section so they are not mistaken for device standing.

A De Novo is the harder route and the more consequential one. There was no predicate, so the agency reviewed the evidence on its own terms, and the grant created a product classification with special controls that every later device of the same type clears against. That makes the De Novo holder the reference point for its category rather than a member of it. Several vendors elsewhere on this page hold 510(k) clearances whose predicate is a device in this table.

Four vendors on the cleared list carry a Predetermined Change Control Plan on at least one cleared product: Qure AI, ArteraAI, PathAI, CLEW Medical. A change control plan is pre agreed room to modify an authorised model inside an envelope the regulator has reviewed, which is the opposite of the more common pattern in this index, where a model evolves continuously with no published change control and a buyer cannot know whether current behaviour matches the published evidence. Ask any cleared vendor whether its clearance carries one, what sits inside the envelope, and how customers are notified when the model moves within it.

87 vendors, grouped by primary category with the largest group first, each linking to the record the line was read from. The pathway column names the instruments the record evidences. The right hand column restates what the clearance covers and, where the record draws a boundary, what it does not. Where the vendor's own material and the regulatory record disagree, the record wins and the disagreement is stated.

7 vendors have a submission filed or under review with no clearance yet on the product, and 5 hold Breakthrough Device designation with no clearance or authorisation on record. Both are legitimate positions, and several of the cleared vendors above passed through exactly these stages. What they are not is permission to market a device clinically, and at least one independent directory already describes a designated product on this page as a cleared Class II device, which is wrong.

Breakthrough Device designation is a status granted on preliminary evidence for technologies addressing serious conditions. It expedites interaction with the regulator. It is not a finding that the device works and it confers no authorisation. The vendors below say so themselves in most cases, and the index records the ones that appended a correction to their own announcement as the disciplined exception.

Establishment registration and device listing are filing obligations. They record that a manufacturer has told the FDA it exists and what it lists, and they involve no review of safety or effectiveness. The agency states that registration does not denote approval and that using it to suggest endorsement is improper. 4 vendors in the index present registration or listing as their regulatory status, and one of them already appears on a clinic's published list of assessment tools described as FDA cleared, beside devices that genuinely are.

2 further vendors are described as cleared in peer reviewed literature or third party coverage while their own materials use cleared, registered and approved interchangeably, and no submission number was retrieved. They sit between the two lists until a number is in hand, because the difference between the two lists is exactly the difference a submission number settles.

23 vendors hold a regulatory authorisation somewhere other than the United States and none there. The larger group, 18 vendors, holds marks that a notified body or a national regulator examined: CE under the European medical device or in vitro diagnostic regulations, UKCA Class IIa or above, Korean MFDS approval, Health Canada licensing or Singapore HSA registration. Several are category firsts in Europe and several cleared a heavier clinical evidence bar than a predicate based 510(k) requires. A United States hospital still cannot deploy any of them clinically on the strength of it.

The smaller group, 5 vendors, holds Class I registration in the United Kingdom or European Union. Class I is the lowest risk classification and conformity is declared by the manufacturer rather than assessed by a notified body, so it is a registered declaration rather than a regulator's review of the software. Three of the five are ambient scribes, and the same products are unregulated documentation tools in the United States, which is the clearest illustration in the index that regulatory status is a property of a market rather than of a product.

Three further instruments turn up when a buyer searches a vendor name with the word FDA, and each is a real regulatory position that is not a device clearance.

A laboratory developed test is validated and offered by a single accredited laboratory under clinical laboratory certification rather than reviewed by the FDA as a device. It is clinically orderable today, which is real availability at a lower evidentiary bar than clearance. Federal oversight of these tests was contested in court in 2025 and remains in flux, so a buyer should confirm the current position rather than assume it. 6 vendors in the index deliver their AI through this route; more than one of them also holds Level I guideline evidence for the classifier, which is a stronger credential than most cleared devices on this page carry.

Drug discovery vendors are regulated at the asset level as drugs, not at the platform level as devices. Fast Track and Orphan Drug designation are development and review mechanisms, not approvals and not findings of efficacy, and none of the 3 vendors below has an approved product. They are listed so the search lands on the right instrument.

A qualification opinion or a drug development tool qualification is a regulator endorsing a method or a measurement as fit for evidence generation. Unlike a 510(k), which establishes equivalence to a predicate, a qualification is the agency reviewing a novel method on its own merits, and in some respects it is the harder achievement. 3 vendors hold one, two of them alongside device clearances above.

A clearance is evidence about a specific version, on a specific date, for a specific indication for use, and the indication is almost always narrower than the marketing. Read it directly from the regulatory record: it names the population, the modality, the setting and often the reading context the product was evaluated in. Deployment outside that envelope is not prohibited, but it is unevaluated, and the responsibility for evaluating it has moved to the buyer. A per algorithm portfolio, and most of the imaging portfolios above are exactly that, is a collection of separately cleared functions rather than one cleared entity.

A clearance is also not evidence that the product works. It records that a regulator reviewed a submission against a stated intended use and, for a 510(k), found it substantially equivalent to a predicate. Several records above state in terms that clinical data was not required. The AI Health Index grades regulatory status and clinical evidence on separate axes for exactly this reason, and the imaging guide reports how many cleared vendors publish no clinical or operational evidence at all.

1. 01Which submission number covers the specific product and version being quoted, and what does the indication for use say verbatim?
2. 02Is the artificial intelligence inside the cleared indication, or is the clearance on the sensor, the platform or a rule based function beside it?
3. 03Does the clearance carry a Predetermined Change Control Plan, and if not, what governs how the model changes after purchase?
4. 04Which markets is the cleared configuration lawfully available in, and does the product a European or Canadian buyer sees differ from the United States one?
5. 05If the answer is registered, listed or designated rather than cleared, what is the written basis for marketing the product clinically today?