Israeli startup AEYE Health announced last week that it had received 510(k) clearance from the FDA for its AI-based screening tool for diabetic retinopathy.
The AEYE-DS system, which received the green light from the agency earlier this monthuses images of each eye to detect signs of more than light diabetic retinopathya complication of diabetes that can lead to blindness or other serious vision problems.
He is currently licensed to use images obtained by the Topcon NW-400 Desktop Retinal Camera. AEYE said it is working to obtain approval to use the system with a wearable camera and is investigating its use for screening for glaucomatous optic neuropathy.
“The time has finally come for autonomous screening technology to surpass the efficiency of the human expert,” AEYE board member Dr. Sean Ianchulev said in a statement. “The implications are that it can be practical for deployment to the front lines of population health – primary care offices, where more than 99% imaging and image diagnostic acquisition unique are synonymous with success in the market.”
THE GREAT TREND
Digital Diagnostics, formerly known as IDx, has received FDA de novo clearance in 2018 for its autonomous software for the detection of diabetic retinopathy in adults. The company has also developed in 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 its distribution and invest in sales and marketing.
Another company focused on AI-assisted diabetic retinopathy detection, Eyenuk, announced that it has raised $25 million in a Series A round in October. Eyenuk’s software received a FDA 510(k) in 2020.
Google has also been researching the use of AI for eye screenings with its automated retinal disease assessment tool. In spring, the tech giant said it was investigating whether a basic photo of the exterior of the eye on a smartphone could detect disorders, so users could perform at-home assessments.