Israeli startup AEYE Health announced last week it had received FDA 510(k) clearance for its AI-based screening tool for diabetic retinopathy.
The AEYE-DS system, which received the agency’s green light earlier this month, uses images from each eye to detect signs of more-than-mild diabetic retinopathy, a complication from diabetes that can lead to blindness or other serious vision problems.
It’s currently cleared to use images obtained by the desktop retinal camera Topcon NW-400. AEYE said it was working to receive clearance to use the system with a portable camera, and that it’s studying use for screening glaucomatous optic neuropathy.
“The time has finally come for autonomous screening technology to exceed the efficacy of the human expert,” AEYE board member Dr. Sean Ianchulev said in a statement. “The implications are that it can be practical for deployment on the front lines of population health – the primary care offices,