On-the-spot detection of diabetic retinopathy with the handheld AI fundus camera
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.
Sensitivity |
Specificity |
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.
The Optomed Aurora AEYE sets a new standard in diabetic eye screening offering fast and high-quality screening of diabetic retinopathy with on-the-spot results. Screening with unmatched accuracy and precision can be performed by any trained healthcare professional. Our solution is here to close the care-gap and drive improvements in patient outcomes.
The workflow from image capture to result delivery is simple and fast. The AI needs only one image per eye for the analysis and the screening result will be delivered to the camera display in less than 60 seconds.
Visit our US siteFill up the form and we’ll contact you as soon as possible.
Notice that this solution is only available in the US.
[* Optomed Aurora AEYE FDA study https://clinicaltrials.gov/study/NCT05857943 and https://clinicaltrials.gov/study/NCT04612868]