AEYE Health is an American technology company specializing in artificial intelligence-based diagnostics for retinal imaging.[1] [2] Founded by Zack Dvey-Aharon and Danny Margalit, the company has offices in New York and Tel Aviv.[3] [4] AEYE Health’s FDA-cleared AI technology is utilized at the point of care in environments such as primary care offices, endocrinology clinics, and home care to conduct diabetic eye exams.[5]
AEYE Health was founded in 2018 by Zack Dvey-Aharon and Danny Margalit.[2] [6] Since its founding, it has received funding from multiple organizations.[7]
In February 2022, AEYE Health reported results from its FDA phase III clinical trial for the autonomous detection of more-than-mild diabetic retinopathy using the AEYE Diagnostic System (AEYE-DS).[8] [9] Utilizing a single image per eye, the AI system demonstrated 93.0 percent sensitivity and 91.4 percent specificity for detecting referable diabetic retinopathy with over 99 percent imageability on the Topcon NW-400 desktop camera. When tested with the Optomed Aurora handheld camera, it showed 91.9 percent sensitivity and 93.6 percent specificity with over 99 percent imageability. In November 2022, AEYE Health received FDA clearance to market its fully autonomous diabetic retinopathy screening system with a retinal camera.[9] [10]
In April 2024, AEYE Health was granted a second FDA clearance for the first fully autonomous AI that diagnoses referable diabetic retinopathy from retinal images obtained by a handheld camera.[11] [12] The handheld camera is portable, which enables point-of-care screening both in clinics and at home.[12]
AEYE Health uses artificial intelligence to autonomously detect various conditions from retinal images and is compatible with several types of retinal cameras, including handheld models. Autonomous AI as defined by the American Medical Association is AI that automatically interprets data and independently generates clinically meaningful conclusions without concurrent physician or other qualified healthcare professional (QHP) involvement.[13]
The proprietary algorithm of the AEYE-DS system analyzes the image and delivers a fully autonomous AI-based diagnosis in seconds.[2]