FDA Approves First Fully Autonomous Handheld AI device for Diabetic Retinopathy Screening

AEYE Health, the leading company for AI retinal imaging and diagnostics, is thrilled to announce that it received the first ever FDA clearance for a fully autonomous AI that diagnoses referable diabetic retinopathy from retinal images obtained by a handheld camera. Combining a fully autonomous AI with a portable handheld device introduces a new and affordable screening solution to address the leading cause of blindness in the working age. The portable solution is especially suited for point-of-care screening, enabling screenings wherever patients are located - whether in clinic or at-home.

AEYE Diagnostic Screening technology (AEYE-DS) is already cleared by the FDA and commercially available with a tabletop imaging device, and will now become the first and only AI solution to allow autonomous screening anywhere using the Optomed Aurora portable handheld device. AEYE-DS is also the only solution that screens patients using just 1 image per eye with over 99% imageability.

This new FDA clearance is based on two large-scale prospective phase-III studies, in which AEYE-DS demonstrated best-in-class efficacy and imageability. Diagnostic sensitivity was in the range of 92%-93% and specificity was in the range of 89%-94%. In both studies, over 99% of patients received a diagnostic result. The AI produced its diagnostic results using only a single image from each eye, rarely requiring dilation.

Screening for diabetic retinopathy with AI is of tremendous public health importance and is now reimbursable in the United States using the newly approved, first ever AI CPT code 92229 for autonomous screening. Additionally, it serves as a major HEDIS measure for most health plans.

There are approximately 40M people with diabetes in the US and over 500M worldwide, all of whom are at risk of diabetic retinopathy, the leading cause of blindness in the working age population. In fact, an estimated 85% of patients with diabetes over the age of 40 will develop diabetic retinopathy. Although it is the leading cause of blindness in the working age, with timely detection, vision loss can be prevented. Unfortunately, the vast majority of people with diabetes in the US and worldwide find themselves unable to obtain annual eye exams.

"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," says Zack Dvey-Aharon, Ph.D., Co-Founder & CEO of AEYE Health. "In the coming years our fully-autonomous screening technology will become standard across points of care in the US. We believe this innovation will prevent the blindness of millions of people in the US and around the world." Dr. Dvey-Aharon adds: "AEYE keeps working to expand the boundaries of diagnostic screening beyond diabetic retinopathy. Our science is evidently the strongest in this space and we're proud to make such unbelievable impact."

Dr. Ianchulev, Professor of Ophthalmology at New York Eye and Ear of Mount Sinai and Board member of AEYE Health, says, "This is perhaps the most exciting FDA clearance I've seen in the 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. Earlier systems have struggled because of efficacy, throughput, imageability, portability and need for dilation but we see a major leap forward technologically with this holy grail system that really has it all."