FDA-Cleared AI Directory
Ophthalmic AI Cleared by the FDA
Eye screening AI, including the first products cleared to give a result without a specialist reading the image.
This small field carries outsized importance, because it is where autonomous AI actually arrived in American medicine.
Diabetic retinopathy screening is the reason. The disease is common, it is silent until it is not, the screening image is standard, and there are nowhere near enough eye specialists to read every picture. That combination is what made regulators willing to clear software that returns a result on its own.
If you want to see what a fully autonomous clearance looks like in practice, including the conditions attached to it, this is the field to read.
Device Types in Ophthalmic
The FDA sorts cleared AI into named device types. Each one has its own bar to clear, so the type tells you what the product is allowed to claim.
| Device type | What it is allowed to do | Cleared | Latest |
|---|---|---|---|
| Diabetic Retinopathy Detection AI | Screens photographs of the back of the eye for diabetic damage, in some cases giving the result without a specialist reading it. | 8 | July 2, 2026 |
Newest Ophthalmic Clearances
| Product | Company | Cleared | FDA record |
|---|---|---|---|
| iPredict-DR | iHealthscreen, Inc. | July 2, 2026 | K253704 |
| AEYE-DS | Aeye Health, Inc. | April 23, 2024 | K240058 |
| EyeArt v2.2.0 | Eyenuk, Inc. | June 16, 2023 | K223357 |
| AEYE-DS | Aeye Health, Inc. | November 10, 2022 | K221183 |
| IDx-DR v2.3 | Digital Diagnostics, Inc. | June 17, 2022 | K213037 |
| IDx-DR | Digital Diagnostics, Inc. | June 10, 2021 | K203629 |
| EyeArt | Eyenuk, Inc. | August 3, 2020 | K200667 |
| IDx-DR | Idx, LLC | April 11, 2018 | DEN180001 |
Clearance data comes from the FDA's public 510(k) and device classification records through openFDA. A clearance is a regulatory decision about a product, not a recommendation, and it does not measure how well the product works in your own setting. Confirm the current status and the exact cleared indication on the FDA record before you buy.