AEYE Health’s Diagnostic Screening Cleared for Diabetic Retinopathy

The FDA has granted marketing clearance to AEYE Health’s artificial intelligence (AI)-based diabetic retinopathy diagnostic screening system which requires just one image per eye and shortens screening time to one minute.

The system obtains images using a desktop retinal camera then uses AI to analyze the images. Patients rarely need to have their eyes dilated, the company said.

The FDA clearance was based on phase 3 study results in which the screening system showed 93 percent sensitivity and 91.4 specificity.

An estimated 85 percent of patients with diabetes over 40 will develop diabetic retinopathy, and 90 percent of vision loss caused by this disease can be avoided with early detection and treatment.