AEYE Health has achieved a milestone with the first-ever FDA clearance for a fully autonomous AI capable of diagnosing referable diabetic retinopathy from retinal images obtained by a handheld camera. This breakthrough introduces a new and affordable screening solution to address diabetic retinopathy, the leading cause of blindness in the working-age population.

The AEYE Diagnostic Screening technology (AEYE-DS), already FDA-cleared and commercially available with a tabletop imaging device, will now be accessible for autonomous screening using the Optomed Aurora portable handheld device. Notably, AEYE-DS is the sole solution enabling screenings with just one image per eye, boasting over 99 percent imageability.

The FDA clearance is backed by two large-scale prospective phase-III studies demonstrating AEYE-DS's best-in-class efficacy and imageability. With diagnostic sensitivity ranging from 92 percent to 93 percent and specificity from 89 percent to 94 percent, over 99 percent of patients received a diagnostic result. Remarkably, the AI achieved its diagnostic outcomes using only a single image per eye, minimizing the need for dilation.

Diabetic retinopathy screening with AI holds significant public health implications, especially as it is now reimbursable in the United States using the newly approved CPT code 92229 for autonomous screening. Additionally, it serves as a critical HEDIS measure for most health plans.

With approximately 40 million people affected by diabetes in the US and over 500 million worldwide, the risk of diabetic retinopathy is pervasive. Despite its prevalence as the leading cause of blindness in the working-age population, timely detection can prevent vision loss. Unfortunately, the majority of individuals with diabetes struggle to access annual eye exams.

Zack Dvey-Aharon, Ph.D., Co-Founder and CEO of AEYE Health said, "This is the 'holy grail' of eye screening - fully autonomous AI, using either portable or tabletop retinal cameras and a procedure that takes a minute to perform, alongside the best-in-class diagnostic efficacy." 

Dr. Ianchulev, Professor of Ophthalmology at New York Eye and Ear of Mount Sinai and Board member of AEYE Health, said, "This is perhaps the most exciting FDA clearance I've seen in recent years. Such meaningful and impactful innovation – not only on the technology and clinical care front but also for population health. A simple click without dilation right when you visit your primary care doctor, at the pharmacy, or even at home, can instantly inform you about diabetic retinopathy. This can streamline care, reduce patient burden, and ultimately ensure exponential access to essential sight-saving service."

AEYE Health remains committed to advancing diagnostic screening beyond diabetic retinopathy, with a focus on delivering solutions backed by scientific evidence.