NEW YORK—AEYE Health, a leading company for AI-based retinal imaging and diagnostics, announced that it received a 510(k) clearance from the U.S. Food & Drug Administration (FDA) to market its diagnostic screening system for diabetic retinopathy. Screening diabetics for retinopathy using AI has recently become reimbursable in the U.S. using the newly approved CPT code 92229 for AI-diagnostic screening. AEYE's FDA approval is based on pivotal Phase III study results which redefine both efficacy and usability of autonomous screening diagnostics in ophthalmology, which include:

● Best-in-class clinical efficacy with 93 percent sensitivity and 91.4 percent specificity.

● Recognition as the first and only solution that requires only a single image per eye, which shortens the screening process to one minute and increases its practicality and seamlessness.

● Best-in-class imageability, delivering a diagnostic result for over 99 percent of patients and rarely requiring dilation.

The technology's accuracy, combined with the need to obtain only a single image per eye and the rare need to dilate, makes AEYE's solution uniquely suited for use in primary care, according to AEYE.

 AEYE with Topcon NW-400 retinal camera.
The AEYE-DS is indicated for use with images obtained by Topcon NW-400, a leading desktop retinal camera. The company is continuing its work to receive clearance for the first diagnostic screening solution for a portable camera following its pivotal study data announced earlier this year.

AEYE is also advancing a follow-on program for the screening of glaucomatous optic neuropathy where the company recently announced high diagnostic potential with sensitivity of 92.2 percent and specificity of 92.6 percent and expects to initiate FDA pivotal trials soon.

"This is a huge step in revolutionizing diagnostic screening for diabetic retinopathy. AEYE's technology delivers the first practical solution, as it features best-in-class efficacy alongside best-in-class usability, having the only one-image-per-eye solution and highest general and dilation-free imageability data," said Zack Dvey-Aharon, Ph.D., CEO of AEYE Health.

"AEYE is still working to obtain clearance for the first and only diagnostic screening solution with a portable camera. We cannot be more excited to lead the innovation in this space with the goal of saving millions of people from losing their vision."

Tsontcho Ianchulev, MD, MPH, professor of ophthalmology at New York Eye and Ear of Mount Sinai and board member of AEYE Health, remarked, "The time has finally come for autonomous screening technology to exceed the efficacy of the human expert. The implications are that it can be practical for deployment on the front lines of population health—the primary care offices, where over 99 percent imageability and single image diagnostic acquisition are tantamount to market success."