Research Update

AI System for Detecting Diabetes-related Retinopathy Receives FDA Clearance

The US Food and Drug Administration has granted 510(k) clearance to Eyenuk Inc., a global artificial intelligence medical technology and services company to market its EyeArt® autonomous AI System for detecting Diabetes-related Retinopathy1.

Diabetes-related Retinopathy is the most common form of Diabetes-related eye disease, affecting approximately 93 million people worldwide and existing in two main forms; non-proliferative and proliferative Diabetes-related Retinopathy. Non-proliferative Diabetes-related Retinopathy is the early form in which high glucose levels in the bloodstream causes blockages to develop in blood-vessels within the eye, resulting in some leakage. In proliferative Diabetes-related Retinopathy, new and immature blood-vessels grow in an effort to compensate for the damaged blood-vessels. However, these newly-formed blood-vessels are weaker and burst, leaking blood into the vitreous cavity, causing “floaters” or “spots” to develop in the visual field.

The EyeArt® system is designed to automatically detect more than mild Diabetes-related Retinopathy and vision-threatening Diabetes-related Retinopathy in adults living with Diabetes with a single test. Clearance was based on results from a prospective clinical trial involving 380 individuals at seven primary care sites and 275 individuals at four ophthalmology sites. The EyeArt® system demonstrated 96% sensitivity and 88% specificity in detecting more than minor Diabetes-related Retinopathy and 92% sensitivity and 94% specificity in detecting vision-threatening Diabetes-related Retinopathy2.

The system is indicated for use with the Canon CR-2 AF and the Canon CR-2 Plus AF fundus cameras and Eyenuk are actively planning to expand the list of Eyeart-compatible imaging devices. Additionally, Autonomous AI for diabetic retinopathy screening will likely be covered by payors starting 2021.

 

References:

  1. FDA clears EyeArt AI system for diabetic retinopathy screening. Available at: https://www.healio.com/news/ophthalmology/20200806/fda-clears-eyeart-ai-system-for-diabetic-retinopathy-screening. Accessed August 2020.
  2. Eyenuk Announces FDA Clearance for EyeArt Autonomous AI System for Diabetic Retinopathy Screening. Available at: https://www.eyenuk.com/en/articles/news/eyenuk-announces-eyeart-fda-clearance/. Accessed August 2020.
Newsletter Signup

To keep up to date with our news and activities,
please leave your details below

GDPR Compliance Please indicate your consent for Retina International to contact you via the email address listed for the purposes of general alerts and newsletters.