AEYE Health receives FDA 510(k) for AI-backed diabetic retinopathy screening

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, where over 99% imageability and single image diagnostic acquisition are tantamount to market success.”


Digital Diagnostics, formerly known as IDx, received FDA De Novo clearance in 2018 for its autonomous software for detecting diabetic retinopathy in adults. The company also expanded into dermatology with the acquisition of 3Derm about two years ago. 

Earlier this year, Digital Diagnostics raised $75 million in Series B funding to advance its product roadmap, expand distribution and invest in sales and marketing.

Another company focused on AI-backed detection of diabetic retinopathy, Eyenuk, announced it had raised $25 million in a Series A round in October. Eyenuk’s software received an FDA 510(k) in 2020.

Google has also been researching using AI for eye screenings with its Automated Retinal Disease Assessment tool. In the spring, the tech giant said it was studying whether a basic smartphone photo of the outside of the eye could detect disorders, so users could conduct assessments at home.

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