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.”

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