AEYE Health announced that it received a 510(k) clearance from the FDA to market its diagnostic screening system for diabetic retinopathy.
Screening diabetics for retinopathy using AI has recently become reimbursable in the United States using the newly approved CPT code 92229 for AI-diagnostic screening. According to AEYE Health, the FDA approval is based on pivotal phase 3 study results which redefine both efficacy and usability of autonomous screening diagnostics in ophthalmology, which 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.
View EyewireTV's coverage of the FDA approval here.
Furthermore, AEYE Health is 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% and specificity of 92.6% 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," 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".
