AEYE Health

AEYE Health, a digital health firm established in 2018, operates from New York and Tel Aviv. The company was co-founded by Zack Dvey-Aharon, PhD, and Danny Margalit. Dvey-Aharon, the CEO, is a serial entrepreneur with a PhD in machine learning from Tel Aviv University and a background in the Israeli Defense Forces' intelligence corps. His interest in the field began at a young age and was solidified during his PhD research, where he recognized the eye's potential as a mirror to the body's health. Margalit, the COO, previously co-founded Aladdin, which had a NASDAQ IPO.

The company's core business revolves around providing fully autonomous, AI-powered diagnostic screening solutions for retinal imaging. This technology is designed to be integrated into primary care settings, endocrinology clinics, pharmacies, and even home-care environments, making retinal screenings more accessible and affordable. By enabling non-specialists to conduct these screenings, AEYE Health aims to increase adherence to annual eye exams, particularly for the millions of diabetic patients at risk of diabetic retinopathy, a leading cause of blindness in working-age adults. The business model is supported by a CPT code for autonomous AI-based screening, which allows healthcare providers to be reimbursed for the service.

AEYE Health's flagship product is the AEYE-DS, an AI-based system that analyzes retinal images to detect various conditions. In November 2022, the company received its first FDA 510(k) clearance to market the system for detecting more-than-mild diabetic retinopathy. A significant milestone occurred in April 2024, when AEYE Health secured a second FDA clearance for its technology to be used with a portable, handheld camera, the Optomed Aurora. This clearance established the AEYE-DS as the first fully autonomous AI solution cleared for use with both portable and tabletop devices. The system delivers diagnostic results in under a minute, using just a single image per eye, and rarely requires pupil dilation, enhancing its usability in point-of-care settings. Clinical studies demonstrated high sensitivity and specificity for the technology. Beyond diabetic retinopathy, the company is developing its platform to screen for other conditions like glaucoma, AMD, hypertension, and cardiovascular risk.

Keywords: retinal imaging, diabetic retinopathy screening, artificial intelligence in healthcare, medical diagnostics, point-of-care testing, FDA clearance, digital health, fundus photography, autonomous AI, eye disease detection, telehealth, medical imaging analysis, preventative medicine, primary care diagnostics, portable medical devices, ophthalmology AI, glaucoma screening, AMD detection, health tech, CPT code 92229