AEYE Health Announces FDA Approval of World’s First Fully Autonomous AI System for Portable Diabetic Retinopathy Screening

AEYE Health's licensing enables the prevention of the leading cause of blindness in the global working-age population, making screening possible anywhere.

Recently, AEYE Health, a leading company in the field of artificial intelligence retinal imaging and diagnosis, announced that it has received the first-ever FDA approval for a fully autonomous artificial intelligence capable of diagnosing referable diabetic retinopathy from retinal images obtained via handheld cameras. Combining fully autonomous AI with portable handheld devices introduces a new, cost-effective screening solution to address the leading cause of blindness among working-age adults. The portable solution is particularly suitable for point-of-care screening, enabling screenings wherever patients are, whether in clinics or at home.

AEYE Diagnostic Screening Technology (AEYE-DS) has received FDA approval and is now available on the market alongside desktop imaging devices. It will become the first and only artificial intelligence solution that allows autonomous screening anywhere using the Optomed Aurora portable handheld device. AEYE-DS is also the only solution that screens patients using just one image per eye, with an imaging success rate of over 99%.

"This is the 'Holy Grail' of eye screening — fully autonomous artificial intelligence, using portable or desktop retinal cameras, completed in just one minute, while delivering top-tier diagnostic results."

This new FDA approval is based on two large-scale prospective Phase III studies, in which AEYE-DS demonstrated best-in-class efficacy and imaging capabilities. Diagnostic sensitivity ranged between 92%-93%, and specificity between 89%-94%. In both studies, over 99% of patients received a diagnostic result. The artificial intelligence generated diagnostic results using a single image of each eye, with pupil dilation rarely required.

Using AI to screen for diabetic retinopathy has significant public health importance and can now be autonomously screened using the newly approved first AI CPT code 92229 in the United States. Moreover, it serves as a key HEDIS measure for most health plans.

There are approximately 40 million people with diabetes in the United States and over 50 million worldwide who are at risk of developing diabetic retinopathy, which is the leading cause of blindness among the working-age population. In fact, it is estimated that 85% of people with diabetes aged 40 and above will develop diabetic retinopathy. Although it is the primary cause of blindness in the working-age population, vision loss can be prevented with timely detection. Unfortunately, the majority of people with diabetes in the U.S. and around the world find themselves unable to access annual eye exams.

"This is the 'Holy Grail' of eye screening — fully autonomous artificial intelligence using a portable or desktop retinal camera that takes only a minute while delivering top-tier diagnostic results," said Dr. Zack Dvey-Aharon, co-founder and CEO of AEYE Health. "Our fully automated screening technology will become the standard at all U.S. healthcare points in the coming years. We believe this innovation will prevent millions of people from going blind in the U.S. and around the world." Dr. Dvey-Aharon added, "AEYE has been working to expand the boundaries of diagnostic screening beyond diabetic retinopathy. Our science is clearly the strongest in this field, and we are proud to be making such an incredible impact."

Dr. Ianchulev, Professor of Ophthalmology at Mount Sinai Eye and Ear in New York and member of the AEYE Health Board, said: "This could be the most exciting FDA approval I've seen in recent years. This meaningful and impactful innovation — not only in technology and clinical care but also in population health. When you visit your primary care doctor, the pharmacy, or even at home, with just a click, without dilation, you can immediately be informed about diabetic retinopathy. This can streamline care, reduce the burden on patients, and ultimately ensure exponential access to essential vision protection services. Early systems struggled due to efficacy, throughput, imaging, portability, and the need for dilation, but we are seeing a significant technological leap with this system that truly has it all — the holy grail."

AEYE Health is a leading digital health company specializing in diagnostic AI for retinal imaging. Its solutions provide fully autonomous, AI-based diagnostic screening with best-in-class clinical outcomes and superior usability. The company designs practical, accurate, and easily accessible diagnostic screening solutions. Its flagship product, AEYE-DS, enables instant screening for diabetic retinopathy to ensure that diabetic patients are regularly screened. Outside the United States, AEYE Health offers over 30 top-tier AI indications through its AEYE-CS (Comprehensive Screening) solution, including sight-threatening and systemic indications.

This Issue's Planning: Shen Li

Editorial Responsibility: Chen Baolin

Author of this article: Yun Ye Xuan

Post-production:Ling Wujuan