FDA-Authorized AI Devices in Ophthalmology
Compare FDA-authorized retinal screening AI by purpose, workflow, and whether a specialist interprets the image.
Ophthalmology AI devices do not all do the same job. Some screen for a specific disease at the point of care and return an autonomous result. Others help an eye specialist detect, measure, or review a finding.
Start with who captures the image, who receives the result, and whether the device gives a diagnosis or supports one.
| 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 (Formerly IDx-DR) | Digital Diagnostics | De Novo | 2018 | Retinal photography | Autonomously detects more-than-mild diabetic retinopathy |
Choose The Workflow Before The Product
- Name the clinical job. A diabetic retinopathy screening system answers a narrower question than software used for specialist image review.
- Identify where the image is captured. A primary care workflow needs trained staff, compatible imaging equipment, an image-quality check, and a clear referral step.
- Know who makes the final call. LumineticsCore can return an autonomous result for its stated indication. Many other products support an eye specialist rather than replacing interpretation.
- Check the exact label. Patient age, prior diagnosis, camera compatibility, intended user, and disease threshold can change whether a device fits the planned setting.
What The Regulatory Route Tells You
De Novo authorization creates a new device classification when there is no suitable predicate for a novel low-to-moderate-risk device. A 510(k) clearance shows substantial equivalence to a legally marketed predicate for the stated intended use. Neither label makes two products interchangeable.
Verify The Current Record
Use this page to compare the role each device plays. Then confirm the current authorization and public labeling in the FDA's AI-Enabled Medical Device List and the manufacturer's instructions for use.