The FDA has granted clearance to AEYE Health for its fully autonomous artificial intelligence (AI) diagnostic screening system for diabetic retinopathy (DR)—the first-ever clearance of a technology of this kind.
Refresh me on AEYE Health.
Launched in 2018 and headquartered in New York, New York, AEYE Health is a venture-backed digital health company focused on providing fully autonomous, artificial intelligence (AI)-based retinal imaging and diagnostics for retinal imaging.
Now this system.
The AEYE Diagnostic Screening (AEYE-DS) is designed to detect more-than-mild DR in diabetes patients ages 22+ with no prior DR diagnosis.
How it works: The technology captures images from both eyes of a patient (using just one image per eye) via a desktop camera (Topcon NW-400) and uses AI to analyze retinal data.
The timing: Diagnostic results are available in just 1 minute (vs standard screening screenings—which typically take 15 to 20 minutes).
Note: The FDA already cleared the system in November 2022 for AI-based DR diagnostic screening, making it commercially available with a tabletop imaging device.
What’s the difference between this clearance and the previous one?
Quite simply: portability.
This newest designation enables the system to conduct “autonomous screening anywhere using the Optomed Aurora portable handheld device,” according to AEYE Health.
Gotcha. What kind of clinical data is available?
Two pivotal phase 3 studies (NCT04612868) and (NCT05857943) evaluated whether AYE-DS could detect DR using a single image per eye, with both a desktop and handheld camera.
Data from the first phase 3 study found the following for each technology:
- Topcon NW-400 (desktop camera)
- 93% sensitivity and 91.4% specificity
- Optomed Aurora (handheld camera)
- 91.9% sensitivity, 93.6% specificity
And cumulatively?
For both studies, diagnostic sensitivity was reported in the range of 92% and 93%, while specificity was in the range of 89% and 94% for both systems.
Note: Both systems’ imageability (in both studies) recorded a diagnostic result of over 99% of patients.
What’s the big picture?
While there are currently an estimated 40 million diabetics in the U.S., only 20 to 60% will undergo an annual DR screening.
The addition of AEYE Health’s AEYE-DS—plus AI-diagnostic screenings' recent reimbursable CPT code (# 92229) in the U.S.—enables ECPs to provide diabetic patients with a quicker option for early diagnosis and intervention.
“This is the 'holy grail' of eye screening,” according to AEYE Health’s CEO and co-founder Zack Dvey-Aharon, PhD.
And for the future?
Per Dvey-Aharon, the company intends to make its technology available as a standard form of care across the country.
“We believe this innovation will prevent the blindness of millions of people in the U.S. and around the world,” he stated.
Lastly, where can I schedule a demo of this?
Click here (and scroll down).