AEYE Health Receives FDA 510(k) for AI Diabetic Retinopathy Screening

Israeli startup AEYE Health announced last week that it has received FDA 510(k) clearance for its AI-based diabetic retinopathy screening tool.

The AEYE-DS system that received the green light from the agency earlier this month used images from each eye to detect signs of more-than-mild diabetic retinopathy, a complication of diabetes that can lead to blindness or other serious vision problems.

It is currently allowed to use the images obtained with the Topcon NW-400 desktop retinal camera. AEYE said it is working to obtain approval to use the system with a portable camera and is studying use to screen for glaucomatous optic neuropathy.

“The time has finally come for autonomous review technology to surpass the efficiency of a human expert,” AEYE board member Dr. Sean Ianchulev said in a statement. “The implications are that it may be practical for use on the front lines of population health – in primary care offices, where greater than 99% visibility and single-image diagnostic capture equates to market success.”


Digital Diagnostics, formerly known as IDx, received 2018 FDA De Novo Approval for its Autonomous Software to Detect Diabetic Retinopathy in Adults. The company also expanded into dermatology with the acquisition of 3Derma about two years ago.

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

Another company focused on detecting diabetic retinopathy with the help of artificial intelligence, Eyenuk, announced that raised $25 million in Series A in October. Eyenuk’s software received FDA 510(k) 2020.

Google has also explored using artificial intelligence for eye exams with its tool to automatically assess retinal disease. In spring, the tech giant said it was studying whether a basic smartphone photograph of the outside of the eye could detect the disorder so users could conduct assessments at home.