AEYE Health, specializing in artificial intelligence-based imaging and diagnostics, has announced receiving the first-ever FDA approval for a fully autonomous AI diagnosing diabetic retinopathy. The integration of fully autonomous AI with a handheld device presents a new, cost-effective screening solution for the leading cause of blindness in the working-age population. The mobile solution is particularly suitable for point-of-care testing, enabling examinations wherever patients are – whether in clinics or at home.
The AEYE-DS technology has already been FDA-cleared and commercially available with a tabletop imaging device, and will now become the first and only artificial intelligence solution allowing autonomous screening anywhere through the Optomed Aurora - a handheld device.
AEYE-DS is also the only solution capable of screening patients with just one image per eye, with an image quality exceeding 99%.