New York – September 15, 2026 -- AEYE Health published peer-reviewed results in Frontiers in Digital Health confirming its FDA-cleared AEYE-DS system achieved over 99% imageability across three prospective, controlled pivotal trials involving more than 1,200 diabetic patients.
Trial data validate the clinical foundation behind AEYE-DS's two FDA clearances
The study, covering trials AEYE-1, AEYE-2 and AEYE-3, benchmarked the autonomous AI against reading center multi-expert clinical review. AEYE-DS requires only a single image per eye, works with both portable handheld and tabletop cameras, and rarely requires pupil dilation -- making it the only FDA-cleared portable autonomous solution for diabetic retinopathy on the market, according to the company.
Sensitivity reached 100% for severe diabetic retinopathy cases across all three trials
For detecting more-than-mild diabetic retinopathy (mtmDR), the portable device recorded sensitivity of 92%-93% and specificity of 89%-94%, while the tabletop version posted 93% sensitivity and 91.4% specificity. Critically, the system achieved 100% sensitivity for ETDRS scores of 43 or higher, meaning no severe cases were missed in any of the three studies. Intra-operator repeatability reached 99%, indicating consistent results when the exam is run by general clinic staff rather than eye care specialists.
Screening gap persists despite annual exam guidelines
Diabetic retinopathy remains the leading cause of preventable blindness among working-age adults in the U.S. Over 60% of diabetic patients skip recommended annual eye exams due to accessibility barriers and a shortage of specialists, a gap AEYE Health says its point-of-care model is designed to close.
CEO says no other cleared solution matches the combined feature set
"AEYE-DS finally makes diabetic eye exams practical at the point of care: portable and tabletop devices, just one image per eye, no dilation, and best-in-class diagnostic efficacy," said Dr. Zack Dvey-Aharon, Co-Founder and CEO of AEYE Health, adding that the workflow can be completed by clinic staff in about one minute with EHR integration.
The company positions the published trial data as the basis for continued expansion of AEYE-DS across U.S. primary care and specialty clinics.