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FDA Approves Eyenuk’s EyeArt AI System for Diabetic Retinopathy Screening

It ‘will likely be covered by payors starting 2021,’ according to the company.




LOS ANGELES — Eyenuk Inc. announced that it has received 510(k) clearance by the U.S. Food & Drug Administration to market its EyeArt autonomous AI system for diabetic retinopathy.

EyeArt is for use by healthcare providers to automatically detect “more than mild diabetic retinopathy” (mtmDR) and “vision-threatening diabetic retinopathy” (vtDR) in eyes of adults diagnosed with diabetes who have not been previously diagnosed with mtmDR. EyeArt is the first FDA cleared autonomous AI technology that can detect both mtmDR and vtDR in one test, in primary care and eyecare settings, according to a press release from Eyenuk. In addition, EyeArt is also the first FDA-cleared autonomous AI technology that has diagnostic outputs for each eye of a patient.

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The EyeArt AI Eye Screening System provides fully automated DR screening, including retinal imaging, DR grading on international standards and immediate reporting, in a single office visit during a diabetic patient’s regular exam. Once the patient’s fundus images have been captured and submitted to the EyeArt AI System, the DR screening results are available in a PDF report in less than 60 seconds.

While diabetic retinopathy screening is recommended for all diabetic patients, less than half get screened annually, even in the developed world. Since more than 30 million Americans have diabetes and diabetic patients outnumber ophthalmologists by 1,600 to 1 in the U.S., there are “just not enough eye care specialists to meet the DR screening needs of the growing diabetic population,” according to the release.

“This is great news to over 30 million Americans living with diabetes, especially those who may have vision-threatening diabetic retinopathy. 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, founder and CEO of Eyenuk. “This historical FDA clearance is our first major milestone enabled by our prospective, multi-center pivotal clinical trial which took us years to plan and complete.”


The EyeArt system is indicated for use with two models of fundus camera in the U.S.: Canon CR-2 AF and Canon CR-2 Plus AF. Eyenuk plans to expand the list of EyeArt-compatible imaging devices.

Autonomous AI for diabetic retinopathy screening will likely be covered by payors starting 2021, according to the release.



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