Autonomous AI-driven point-of-care screening for diabetic retinopathy compared to reading center multi-expert clinical review: results from three prospective controlled pivotal validation studies with AEYE-DS in over 1,200 patients.

Zack Dvey-Aharon¹, Moshe Livne¹, Dan Margalit¹, Amit Wohl¹, Adi Haupt¹, Rachelle Aviv¹, Ahava Stein², Adi Rachelson², Jonathan Nussdorf^3,4, Tsontcho Ianchulev⁵

¹AEYE Health Inc., New York, NY, United States.

²A. Stein - Regulatory Affairs Consulting Ltd., Kfar Saba, Israel.

³Department of Ophthalmology, Ochsner Health, New Orleans, LA, United States.

⁴Queensland Medical Program, University of Queensland, Brisbane, QLD, Australia.

⁵New York Eye and Ear of Mount Sinai, Icahn School of Medicine, New York, NY, United States.

PubMed PMC DOI PDF

Abstract

PURPOSE: Diabetic retinopathy (DR) remains the leading cause of blindness among working-age adults and requires regular screening to detect progression among the growing global diabetic population. This study evaluated the performance of AEYE-DS, an autonomous artificial intelligence (AI) system designed for high-throughput, point-of-care analysis of retinal images, in detecting more-than-mild dia…

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