Key Takeaways

  • AEYE-DS received the 2026 Prix Galien USA Award for Best Digital Health Solution

  • Clinical trials involving more than 1,200 patients demonstrated 92%-93% sensitivity, 89%-94% specificity, and greater than 99% imageability

  • The FDA-cleared technology enables autonomous diabetic retinopathy screening in primary care settings without physician interpretation

AEYE Health has received the 2026 Prix Galien USA Award for "Best Digital Health Solution" for AEYE-DS, its FDA-cleared autonomous artificial intelligence (AI) technology designed to detect diabetic retinopathy at the point of care without physician interpretation.

The company was selected from 25 nominees in the Best Digital Health category. The award recognizes the work of Zack Dvey-Aharon, PhD, co-founder and CEO of AEYE Health and inventor of AEYE-DS, and the company's development team.

AEYE-DS enables diabetic eye screening during routine primary care visits and in other healthcare settings. The technology uses a single retinal image per eye without dilation and provides diagnostic results in less than 1 minute. It is compatible with portable and tabletop imaging systems, allowing nurses and medical assistants to perform examinations without requiring a specialist to interpret the images.

According to the company, AEYE-DS was evaluated in 3 prospective, controlled, multicenter phase 3 pivotal clinical trials involving more than 1,200 patients. The studies demonstrated sensitivity of 92% to 93%, specificity of 89% to 94%, and imageability exceeding 99%.

The technology has been deployed across dozens of US healthcare systems and hospitals. Its integration with electronic health record systems is designed to streamline documentation, referrals, and reimbursement while expanding access to diabetic retinopathy screening.

"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," Dr. Dvey-Aharon said.

AEYE Health is also developing AEYE-X, an investigational AI-based oculomics platform designed to assess more than 100 health indications using retinal images. The platform targets cardiovascular, metabolic, neurological, and ocular conditions, potentially extending retinal imaging applications beyond traditional eye care.