Back to Health Library

FDA clears fully autonomous AI for portable diabetic retinopathy screening 

Key Takeaways

  • AEYE Health has received the first-ever FDA clearance for a fully autonomous artificial intelligence (AI) that can diagnose diabetic retinopathy using retinal images taken by a handheld camera.
  • According to the company, the new system is especially suited for point-of-care screening at clinics or at home and thus can help address the leading cause of blindness in working-age adults.

AEYE Health has received the first-ever FDA clearance for a fully autonomous AI that can diagnose diabetic retinopathy using retinal images taken by a handheld camera, according to a company-issued press release. In a procedure that takes a minute, the device takes images from each eye using a special camera and through AI captures and analyses data on the retina to help diagnose diabetic retinopathy. This affordable and accessible solution is especially suited for point-of-care screening at clinics or at home, the company stated, and can help address the leading cause of blindness in working-age adults. 

The AEYE diagnostic screening technology is currently commercially available with a tabletop imaging device. The latest FDA clearance will allow for autonomous screening anywhere using the Aurora portable handheld device, U.S.-Israeli AEYE Health said in its statement. “This is the ‘holy grail’ of eye screening — fully autonomous AI, using either portable or tabletop retinal cameras and a procedure that takes a minute to perform, alongside the best-in-class diagnostic efficacy,” Zack Dvey-Aharon, PhD, the company’s cofounder and CEO, said in the release. “We believe this innovation will prevent the blindness of millions of people in the U.S. and around the world.”

Edited by Miriam Kaplan, PhD

Sources:

AEYE Health, “FDA clears fully autonomous AI for portable diabetic retinopathy screening.” Healio Optometry News, April 30, 2024; see source article

Reuters Health Information, “Optomed Oyj, AEYE Health Say Portable Device to Detect Eye Issues Gets FDA Nod.” Medscape Medical News,  May 1, 2024; see source article