Device Tracker
FDA-Cleared AI Devices in Ophthalmology
Retinal screening, including the first autonomous diagnostic AI authorized in the United States.
| Device | Manufacturer | Route | Year | Modality | Function |
|---|---|---|---|---|---|
| AEYE-DS | AEYE Health | 510(k) | 2022 | Retinal photography | Autonomous diabetic retinopathy screening from a single image |
| EyeArt | Eyenuk | 510(k) | 2020 | Retinal photography | Autonomous diabetic retinopathy screening |
| LumineticsCore (IDx-DR) | Digital Diagnostics | De Novo | 2018 | Retinal photography | Autonomously detects more-than-mild diabetic retinopathy |