AEYE Health and its co-founder, Dr. Zack Dvey-Aharon, received the 2026 Prix Galien USA Award for Best Digital Health Solution for their autonomous diagnostic tool, AEYE-DS, designed to prevent blindness from diabetic retinopathy by delivering rapid screening results at primary care points of care.
Software Delivers Rapid Autonomous Retinal Scan Diagnostics
- Autonomous Diagnostics: The software assesses retinal images independently, giving a diagnostic result in under a minute without needing an eye specialist to interpret the scans.
- Streamlined Access: By fitting into routine doctor visits with portable cameras and single images per eye, it bypasses traditional barriers like long wait times and specialist shortages.
- Broadened Health Scans: The company is also developing an investigational platform, AEYE-X, aimed at evaluating over 100 health indicators from a single retinal image.
Recognized Innovation in Blindness Prevention
The Galien Foundation honored AEYE Health during an industry announcement, recognizing the company’s diagnostic program among top-tier healthcare innovations. Often described in biopharmaceutical circles as an equivalent to scientific research prizes, the Prix Galien USA Award singled out the tool for its ability to bring sight-saving screenings directly into everyday clinical settings.
Diabetic retinopathy remains the leading cause of blindness among working-age adults. Caused by progressive damage to retinal blood vessels, the condition typically develops without early symptoms or warning signs. Standard clinical guidelines have long relied on specialized eye examinations to catch microvascular changes before irreversible vision loss sets in. However, scheduling constraints, geographic distance, and insurance hurdles often delay early detection across various healthcare systems.
Clinical Trials Validate Fast Diagnostic Software Workflow
The AEYE-DS system relies on portable and tabletop retinal cameras to capture a single image per eye. The FDA-cleared software evaluates these scans without requiring pupil dilation, producing a diagnostic output in under a minute. The diagnostic tool achieves over 99% imageability, meaning it yields a readable result for virtually every patient evaluated during screenings.
The technology earned its clearance following validation across three prospective, controlled, multicenter phase-III clinical trials involving more than 1,200 patients. Data from these trials demonstrated a sensitivity rate between 92% and 93% and a specificity rate ranging from 89% to 94%. By integrating directly with electronic health record systems, the software automates documentation and patient referrals during routine primary care consultations.
| Trial Parameter | Clinical Metric |
|---|---|
| Study Cohort Size | Over 1,200 patients |
| Clinical Trial Design | Three prospective, controlled, multicenter phase-III pivotal trials |
| Diagnostic Sensitivity | 92% – 93% |
| Diagnostic Specificity | 89% – 94% |
| Imageability Rate | Over 99% |
Expanding Beyond Traditional Eye Care
Dr. Zack Dvey-Aharon reflected on the recognition from the Galien Foundation by emphasizing the broader mission of the organization. “Receiving the Prix Galien Award is one of the greatest honors of my professional life and an extraordinary recognition of the work of the AEYE Health team,” Dvey-Aharon said, adding that their primary focus rests on preserving patient vision through accessible technology. Dvey-Aharon was also named among TIME’s 100 Most Influential People in AI in 2024.
Building on the deployment of AEYE-DS, the company is advancing its investigational AEYE-X platform. This system is designed to assess more than 100 health indications spanning cardiovascular, metabolic, neurological, and ocular conditions. If validated for clinical use, this expansion could transform routine retinal imaging into a comprehensive multi-system health assessment tool available at standard medical clinics.
