The Food and Drug Administration (FDA) has granted 510(k) clearance to EyeArt® autonomous AI System (Eyenuk, Inc) for detecting diabetic retinopathy.

EyeArt is the first FDA-cleared AI technology for autonomous detection of more than mild diabetic retinopathy (mtmDR) and vision-threatening diabetic retinopathy (vtDR). It is indicated for use by healthcare providers to automatically detect mtmDR and vtDR in eyes of adults diagnosed with diabetes who have not been previously diagnosed with mtmDR. The system can be used with 2 models of fundus camera, the Canon CR-2 AF and Canon CR-2 Plus AF, in primary care and eye care settings.

The EyeArt AI System allows clinicians to quickly identify diabetic retinopathy in a single office visit during a regular exam. Once a patient’s fundus images have been captured and submitted to EyeArt, diabetic retinopathy screening results are available within 60 seconds via a PDF report. 

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The 510(k) clearance was based on the analysis of a prospective, multicenter, pivotal clinical trial that evaluated EyeArt in patients with diabetes who were enrolled at primary care and general ophthalmology sites. Findings from the trial showed the system was associated with 96% sensitivity and 88% specificity for detecting mtmDR, and 92% sensitivity and 94% specificity for detecting vtDR. EyeArt correctly identified all eyes with an Early Treatment for Diabetic Retinopathy Study severity (ETDRS) level of ≥43 as mtmDR positive. Moreover, 90% of patients received disease detection results without needing dilation.

Additionally, the study showed that novice operators could obtain medical grade retinal images. In primary care centers, disease detection results were provided for 97% of eyes that received a reading center grading.

“The EyeArt autonomous AI System can now enable safe, effective, and equitable diabetic eye screening at convenient point-of-care locations, with AI results available in less than 1 minute,” said Kaushal Solanki, PhD, founder and CEO of Eyenuk. “This historical FDA clearance is our first major milestone enabled by our prospective, multicenter pivotal clinical trial which took us years to plan and complete.”

The EyeArt AI System was developed with funding from the US National Institutes of Health (NIH) and validated by the UK National Health Service. It will likely be covered by payors starting in 2021. 

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1. Eyenuk announces FDA clearance for EyeArt autonomous AI system for diabetic retinopathy screening. Accessed August 4, 2020.

This article originally appeared on MPR