EyeArt
Eyenuk
Autonomous analysis of retinal images for diabetic retinopathy, including detection of more-than-mild and vision-threatening disease, without clinician interpretation of the image.
At A Glance
- Manufacturer
- Eyenuk
- Medical specialty
- Ophthalmology
- Clearance route
- 510(k)
- Year authorized
- 2020
- Modality
- Retinal photography
- Role in workflow
- Autonomous diagnostic
EyeArt arriving through 510(k) two years after IDx-DR is the clearest illustration of how De Novo works as a mechanism. The first device had to create the classification. The second could claim substantial equivalence to it, which is a far shorter route.
Where It Is Used
- Autonomous diabetic retinopathy screening
- Screening without pupil dilation in many patients
- Retinal screening programs at scale
Limitations Worth Knowing
Autonomous screening devices are indicated for a specific disease question in a specific population, and coexisting pathology outside that question is not assessed. Ungradable images remain a real operational rate and require a referral fallback.
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.