I need a quick recap on AEYE Health.
AEYE Health was launched in 2018 as an AI-based retinal imaging and diagnostics startup company.
Tell me about the system.
The AYE-DS works by capturing images from each eye with a desktop camera (Topcon NW-400) using AI to analyze data of the retina.
The target patient base include those with more-than-mild DR ages +22 diagnosed with diabetes and not previously diagnosed with DR. (via)
Any clinical trials to back this up?
There is! A pivotal phase 3 study—the first of its kind—earlier this year evaluated whether AYE-DS could detect DR using a single image per eye, with both a desktop and handheld camera.
Data showed a 93% sensitivity and 91.4% specificity for the Topcon NW-400 (desktop camera); and a 91.9% sensitivity, 93.6% specificity for the Optomed Aurora (handheld camera). Both systems’ imageability recorded a diagnostic result for over 99% of patients. (via)
What makes this system unique?
A standard screening typically takes 15 to 20 minutes. By only needing a single image per eye, the AYE-DS time is shortened to 1 minute.
What’s the big picture?
With over 35 million diabetics in the U.S., only 15 to 50% will undergo an annual DR screening. With AI-diagnostic screenings having recently been made reimbursable (CPT code 92229) in the U.S., AYE-DS gives diabetic patients and ECPs a quicker option for early diagnosis and intervention.