US FDA Approves Aeye’s Autonomous AI DR Screening with Hand-held Fundus Camera

Aeye Health announced April 30 that the US FDA had approved the company’s autonomous artificial intelligence-aided screening technology for diabetic retinopathy (DR) using a hand-held retinal camera.

The system, Aeye-DS, was first approved by the FDA in November 2022 for use with the fully automatic and non-mydriatic Topcon NW-400 desktop retinal camera.

Aeye Health, of New York and Israel, says Aeye-DS can now be used with the hand-held Optomed Aurora fundus camera. The Aurora features a 50-degree field of view and a high-contrast optical design for detecting small, early-phase retinal changes, Optomed said.

Aeye said combining its AI with a portable device introduces a new and affordable screening solution to address diabetic eye disease, one that’s well suited for care outside an ophthalmologist’s office.

Approval was based on two Phase III studies, in which Aeye-DS showed diagnostic sensitivity of 92 to 93 percent, and specificity of 89 to 94 percent. Aeye said the system produced a result using only a single image from each eye, and the screening rarely required dilation.