AEYE Health’s FDA clearance enables global prevention of the leading cause of blindness in the working age population by making screening accessible anywhere.
NEW YORK, April 30, 2020. AEYE Health, the leading company for AI retinal imaging and diagnostics, 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.
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.
