AEYE Health Receives FDA Clearance for AI-based Autonomous Screening for Diabetic Retinopathy

AEYE Health Receives FDA Clearance for AI-based Autonomous Screening for Diabetic Retinopathy

November 16, 2022

The FDA has granted 510(k) approval to AEYE Health, allowing the company to commercialize its diabetic retinopathy diagnostic screening system.

With the recently approved CPT code 92229 for AI-diagnostic screening, it is now possible to receive reimbursement in the United States for utilizing AI to screen diabetics for retinopathy. The FDA's approval, according to AEYE Health, is based on key phase 3 trial findings that redefine the effectiveness and applicability of autonomous screening diagnostics in ophthalmology. These results include:

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

● Recognition as the first and only solution that requires only a single image per eye, which shortens the screening process to 1 minute and increases its practicality and seamlessness.

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

The AEYE-DS is indicated for use with images obtained by the Topcon NW-400 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.

Additionally, AEYE Health is advancing a follow-up program for the detection of glaucomatous optic neuropathy. The company recently announced this program has a high diagnostic potential with sensitivity and specificity of 92.2% and 92.6%, respectively, and anticipates starting 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," Zack Dvey-Aharon, PhD, CEO of AEYE Health, said in a company news release. "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".

Sean Ianchulev, MD, Professor of Ophthalmology at New York Eye and Ear of Mount Sinai and Board member of AEYE Health, said, "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% imageability and single image diagnostic acquisition are tantamount to market success".