Company Overview
Snapshot
Founded in June 2018 by Zack Dvey-Aharon and Danny Margalit, AEYE Health is a digital health startup with 11–50 employees. The company has raised $10 million across 3 funding rounds from 6 investors. In April 2024, AEYE Health received FDA clearance for its fully autonomous AI to diagnose referable diabetic retinopathy using a portable handheld camera.
Business overview
AEYE Health is a venture-backed digital health company that develops AI algorithms for the immediate and autonomous interpretation of fundus images to diagnose various conditions. Its core technology leverages artificial intelligence, deep learning, machine learning, and computer vision to provide retinal screenings. The company's products empower primary care physicians to detect and prevent vision loss, serving patients and healthcare providers within the Health Tech & Life Sciences sector, specifically in Digital Medical Diagnostics.
Strategic signal
In April 2024, AEYE Health secured FDA clearance for its fully autonomous AI technology, AEYE-DS, to diagnose referable diabetic retinopathy from retinal images captured by a handheld camera. This milestone is significant as it expands the accessibility of their diagnostic solution beyond tabletop devices, enabling more affordable and portable screening. This signals strong regulatory validation and a clear path for market expansion, particularly in primary care settings, addressing a critical need for early detection of a leading cause of blindness.
Log in to access full profile ›Company Intelligence Q&A
- What was a key regulatory achievement for AEYE Health in 2024?
- In April 2024, AEYE Health received FDA clearance for its fully autonomous AI to diagnose referable diabetic retinopathy using retinal images obtained by a handheld camera. This expands on their existing FDA-cleared AEYE Diagnostic Screening technology.
- What strategic partnership did AEYE Health announce in July 2023?
- In July 2023, Intelligent Retinal Imaging Systems (IRIS) announced a partnership with AEYE Health. Under this agreement, IRIS licenses AEYE Diagnostic Screening (AEYE-DS) to integrate with the IRIS Solution, enabling autonomous detection of diabetic retinopathy for IRIS customers.
- What research collaboration did AEYE Health engage in during February 2023?
- In February 2023, UMass Chan Medical School collaborated with AEYE Health on a pilot study to test a handheld, AI-assisted retinal camera for screening diabetic retinopathy in primary care settings. The study received an $800,000 grant from the Israeli-U.S. Binational Industrial Research and Development Foundation.
- What significant scientific advancement did AEYE Health announce in January 2023?
- In January 2023, AEYE Health announced the development of a deep learning algorithm capable of accurately predicting the future development of diabetic retinopathy using fundus imagery of otherwise healthy eyes, highlighting its potential for early disease prediction.
- When did AEYE Health receive its initial FDA clearance for diabetic retinopathy screening?
- In November 2022, AEYE Health received 510(k) clearance from the U.S. Food & Drug Administration (FDA) to market its diagnostic screening system for referable diabetic retinopathy.