AEYE Health is an American-Israeli healthcare technology company which develops AI and computer-vision-powered algorithms to detect various medical conditions and markers from retinal images. AEYE Health's technology is categorized as autonomous AI, designed to replace medical professionals, as opposed to decision-support technologies which are designed to assist them.

Its platform is in use in multiple clinics and hospitals across the United States, including UMass Memorial Health.

History 
AEYE Health was founded in 2018 by Zack Dvey-Aharon and Danny Margalit.

AEYE Health received its first FDA clearance for an autonomous screening solution for diabetic retinopathy in November 2022, following a prospective phase-III clinical study.

Technology and clinical studies 
The company received its first FDA clearance in November 2022 for its AEYE Diagnostic Screening (AEYE-DS) solution, which detects more-than-mild diabetic retinopathy in patients with diabetes. FDA clearance was based on clinical data collected in a prospective clinical study. Study data demonstrated 93.0% sensitivity and 91.4% specificity, with over 99% of subjects receiving a diagnostic result. These results improved on the efficacy of previous clearances granted to Digital Diagnostics and Eyenuk and were obtained using a single image per eye, as opposed to previous studies that required two retinal images per eye.

The company reported phase-III data of >91% sensitivity and specificity for its technology using retinal images obtained with the Optomed Aurora portable retinal camera, with over 99% of patients receiving a diagnostic result. AEYE Health's diagnostic screening solution for diabetic retinopathy using retinal images produced by the Optomed Aurora camera is not yet cleared by the FDA for use in the US.

Publications 
Dvey-Aharon, Zack, and Petri Huhtinen. “Screening for Diabetic Retinopathy in Endocrinology Clinics by Using Handheld Cameras and Applying Artificial Intelligence Algorithms.” Journal of the Endocrine Society 5, no. Suppl 1 (May 3, 2021): A419–20. https://doi.org/10.1210/jendso/bvab048.856.
Rom, Yovel, Rachelle Aviv, Tsontcho Ianchulev, and Zack Dvey-Aharon. “Predicting the Future Development of Diabetic Retinopathy Using a Deep Learning Algorithm for the Analysis of Non-Invasive Retinal Imaging.” BMJ Open Ophthalmology 7, no. 1 (December 1, 2022): e001140. https://doi.org/10.1136/bmjophth-2022-001140.
Bressler, Idan, Rachelle Aviv, Danny Margalit, Yovel Rom, Tsontcho Ianchulev, and Zack Dvey-Aharon. “Autonomous Screening for Laser Photocoagulation in Fundus Images Using Deep Learning.” British Journal of Ophthalmology, May 22, 2023. https://doi.org/10.1136/bjo-2023-323376.

Commercial collaborations 
September 2020 - Optomed and AEYE Health announce their intention to introduce a handheld retinal camera with built-in AEYE technology.
March 2021 - UMass Memorial Health Care and AEYE Health announce a joint project to develop a platform to deploy AEYE Health's technology in hospitals.
February 2023 - UMass Memorial Health Care and AEYE Health launch joint research on the use of AEYE Health's technology in a primary care setting.

References

External links 
 Official website

Israeli companies established in 2008
Health care companies based in New York (state)