The First FDA-Cleared Handheld AI Fundus Camera

Optomed Aurora with AEYE has received FDA-clearance in the US

The Optomed Aurora AEYE with AEYE-DS is the first FDA-cleared handheld AI fundus camera for autonomous diabetic retinopathy detection in the United States. With the exceptional diagnostic accuracy for referable diabetic retinopathy detection it is here to close the care-gap in the eye screening of diabetics and drive significant improvements in patient outcomes and healthcare ratings in the US.

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.