AEYE Health announced that it has received the first FDA clearance for a fully autonomous AI system that diagnoses referable diabetic retinopathy (DR) from retinal images captured by a handheld camera. The clearance is based on 2 large-scale prospective phase 3 studies, in which AEYE Health Diagnostic Screening technology (AEYE-DS) demonstrated best-in-class efficacy and imageability. Diagnostic sensitivity was in the range of 92% to 93% and specificity was in the range of 89% to 94%. In both studies, more than 99% of patients received a diagnostic result. The technology is commercially available with a tabletop imaging device, with screenings available by using the Optomed Aurora portable handheld device. 

“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,” Zack Dvey-Aharon, PhD, cofounder and CEO of AEYE Health, said in a news release.