AEYE Health's FDA-Cleared AI Hits 99% Imageability in 1,200-Patient Trial
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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.