AEYE-DS
AEYE Health
Autonomous diabetic retinopathy detection designed to work from a single retinal image per eye on handheld and desktop cameras.
At A Glance
- Manufacturer
- AEYE Health
- Medical specialty
- Ophthalmology
- Clearance route
- 510(k)
- Year authorized
- 2022
- Modality
- Retinal photography
- Role in workflow
- Autonomous diagnostic
The single-image requirement is the design point. Multi-image protocols with dilation are a substantial barrier in a primary care workflow, and the number of patients screened is generally more consequential to population outcomes than the sensitivity difference between competing algorithms.
Where It Is Used
- Point-of-care retinal screening
- Handheld camera screening programs
- Primary care and pharmacy screening settings
Limitations Worth Knowing
Fewer images means less retinal area assessed. Handheld cameras produce more variable image quality than desktop fundus cameras, and the indication remains specific to diabetic retinopathy.
Regulatory status, indications, and labeling change over time. Confirm current status on the FDA's AI/ML-Enabled Medical Devices list and in the manufacturer's current instructions for use before relying on anything stated here.