Eyenuk, Inc. announced it has received FDA clearance for the Topcon NW400 retinal camera with its EyeArt artificial intelligence (AI) system to automatically detect diabetic retinopathy (DR).
Give me a refresher on this company.
Founded in 2010, Eyenuk is a global AI medical technology company focused on developing real-world AI screening for autonomous disease detection and AI predictive biomarkers.
The company's goal is to screen every eye in order to ensure timely diagnosis of life-threatening diseases like DR, age-related macular degeneration (AMD), and glaucoma.
Now talk about this technology.
Developed with funding from the U.S. National Institutes of Health (NIH) and launched in 2020, the EyeArt AI Eye Screening System is designed as a fully autonomous technology for detecting DR as well as AMD and glaucomatous optic nerve damage, including retinal imaging.
The system works by enabling physicians—in primary care practice, diabetes centers, and optometry/ophthalmology settings— to quickly and accurately provide real-time DR identification in a diabetic patient’s regular exam.
Break this process down.
There are three key steps to the system:
- Step 1: Capture color retinal fundus images of a patient’s eyes.
- Step 2: Submit images to the cloud to be analyzed.
- Step 3: Download the screening results and export a PDF report.
And that’s it!
Exactly how quickly is this process?
According to Eyenuk, a report can be generated in less than 60 seconds following the submission of a patient’s images.
What kind of retinal imaging cameras is this compatible with?
While this clearance is for the use of the EyeArt with the Topcon NW400 retinal camera, the system is already cleared to be used with the Canon CR-2 AF and Canon CR-2 Plus AF cameras.
Gotcha. Any clinical studies to support its use?
Yes! The FDA’s decision was based on results from a prospective, multi-center clinical trial (NCT04984200) that assessed the performance of the EyeArt with the Topcon NW400 for DR detection.
The study enrolled 246 patients (ages 22+) diagnosed with diabetes mellitus and observed the data of each participant undergoing retinal imaging before and after pharmacological dilation.
… and the results?
Per the company, the EyeArt + Topcon NW400 exceeded expectations on the system's performance:
- A 94.4% sensitivity and 91% specificity for more-than-mild DR detection.
- A 96.8% sensitivity and 91.6% specificity for vision-threatening DR detection.
Significance?
Per Eyenuk, the EyeArt is now the first and only AI system cleared by the FDA for use with multiple retinal cameras from different manufacturers.
Where can I see a demonstration of it?
If you happen to be attending the American Diabetic Association’s 83rd Annual Scientific Sessions in San Diego (June 23-26, 2023), you can visit Eyenuk's booth for a demonstration.