AEYE Well being receives FDA 510(ok) for AI-backed diabetic retinopathy screening

Israeli startup AEYE Well being introduced final week it had acquired FDA 510(ok) clearance for its AI-based screening device for diabetic retinopathy.

The AEYE-DS system, which acquired the company’s inexperienced gentle earlier this month, makes use of pictures from every eye to detect indicators of more-than-mild diabetic retinopathy, a complication from diabetes that may result in blindness or different critical imaginative and prescient issues. 

It is at present cleared to make use of pictures obtained by the desktop retinal digital camera Topcon NW-400. AEYE stated it was working to obtain clearance to make use of the system with a transportable digital camera, and that it is finding out use for screening glaucomatous optic neuropathy.

“The time has lastly come for autonomous screening expertise to exceed the efficacy of the human professional,” AEYE board member Dr. Sean Ianchulev stated in a press release. “The implications are that it may be sensible for deployment on the entrance traces of inhabitants well being – the first care workplaces, the place over 99% imageability and single picture diagnostic acquisition are tantamount to market success.”


Digital Diagnostics, previously referred to as IDx, acquired FDA De Novo clearance in 2018 for its autonomous software program for detecting diabetic retinopathy in adults. The corporate additionally expanded into dermatology with the acquisition of 3Derm about two years in the past. 

Earlier this 12 months, Digital Diagnostics raised $75 million in Series B funding to advance its product roadmap, broaden distribution and spend money on gross sales and advertising.

One other firm centered on AI-backed detection of diabetic retinopathy, Eyenuk, introduced it had raised $25 million in a Collection A spherical in October. Eyenuk’s software program acquired an FDA 510(k) in 2020.

Google has additionally been researching utilizing AI for eye screenings with its Automated Retinal Illness Evaluation device. Within the spring, the tech giant said it was finding out whether or not a primary smartphone picture of the skin of the attention might detect problems, so customers might conduct assessments at residence.

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