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Eyenuk Secures the First European Union MDR Certification for Autonomous AI Detection of Diabetic Retinopathy, Age-Related Macular Degeneration, and Glaucoma

Tuesday, January 31, 2023

Eyenuk, a global artificial intelligence (AI) digital health company, and the leader in real-world applications for AI Eye Screening™ and AI Predictive Biomarkers™, has been approved to market its EyeArt® AI eye screening system in the European Union for the new uses of detecting age-related macular degeneration (AMD) and glaucomatous optic nerve damage (a sign of glaucoma).

The EyeArt AI system (version 3.0) has been granted a new European Commission (EC) certification as a Class IIb medical device under the EU’s Medical Devices Regulation 2017/745 (“MDR”) and is intended to detect signs of diabetic retinopathy (DR) (including diabetic macular edema), AMD, and glaucomatous optic nerve damage in patients at risk of vision loss using computerized analysis of images of the retina. The EyeArt AI system was previously approved in the EU for the detection of DR including diabetic macular edema.

This EC Certification makes the EyeArt AI system the first and only autonomous AI solution with Class IIb MDR CE marking for the automated detection of all three eye diseases and will allow Eyenuk customers in the EU to detect the diseases in a single exam using the same set of retinal images. The EyeArt AI system is also the first and only system that is both CE Marked for the detection of the three diseases as well as FDA-cleared in the United States for the detection of DR, the leading cause of blindness among working-age adults.

The EyeArt AI system greatly expands the availability of vision-saving eye screenings by making automated AI diagnosis and coordination of care possible in primary care medical practices without the need for a specialist’s review. The system is integrated with retinal imaging cameras and can be operated by clinical support staff to generate a detailed screening report in less than 30 seconds. In regions with limited access to ophthalmologists, its ability to detect multiple eye diseases with a single exam can help reduce vision loss from these blinding eye diseases.

Malavika Bhaskaranand, Head of Regulatory and Clinical Affairs at Eyenuk, commented, “Achieving MDR certification is a major milestone for Eyenuk and a result of our early adaptation to the more stringent requirements of the new regulation. It reaffirms the strong results from rigorous clinical validation of the EyeArt AI system.”

Kaushal Solanki, Chief Executive Officer and Founder of Eyenuk, commented, “This EC certification multiplies our impact in two ways. First, our autonomous AI can now help many more patients at risk of vision loss – the population at risk of AMD and glaucoma, particularly seniors, in addition to people with diabetes. Second, our AI system can now provide a more comprehensive report for each patient with detection results for three diseases compared to just one previously.”

Solanki continued, “DR, AMD, and glaucoma are all asymptomatic in their early stages. The high sensitivity of the EyeArt AI system, and its ability to be delivered without a specialist, makes it easier to catch the diseases early and to take preventative measures to protect the vision of these patients. We look forward to the opportunity to forge new partnerships with world-class hospitals and healthcare institutions in Europe to help preserve the eyesight of millions across the continent with these diseases.”

EC Certification Caps Year of Breakthroughs for Eyenuk

The EC Certification of the EyeArt AI system caps a year of significant clinical and business milestones for Eyenuk. The company’s accomplishments in 2022 included:

    Securing $26 million in a Series A financing round, bringing the company’s total funding to over $43 million
    Reaching the new milestone of 70,000 patients screened using the EyeArt AI system globally since August 2020, by far the most screenings by any FDA-cleared autonomous AI system
    Growing the number of locations using the EyeArt AI system to more than 200 in 18 countries and throughout the US
    Publication of a major peer-reviewed study finding that the EyeArt AI system is far more sensitive in identifying referable DR than dilated eye exams by ophthalmologists and retina specialists
    Winning Juniper Research’s Future Digital Health award for the “Best Digital Diagnostics Solution”
    Being named a finalist for the UCSF Digital Health Award

About Eyenuk, Inc.

Eyenuk, Inc. is a global artificial intelligence (AI) digital health company and the leader in real-world AI Eye Screening™ for autonomous disease detection and AI Predictive Biomarkers™ for risk assessment and disease surveillance. Eyenuk is on a mission to screen every eye in the world to ensure timely diagnosis of life- and vision-threatening diseases, including diabetic retinopathy, glaucoma, age-related macular degeneration, stroke risk, cardiovascular risk, and Alzheimer’s disease. Find Eyenuk online on its website, Twitter, Facebook, and LinkedIn.

About the EyeArt AI System

The EyeArt AI system provides fully autonomous screening for diabetic retinopathy (DR), age-related macular degeneration (AMD), and glaucomatous optic nerve damage, including retinal imaging, based on international clinical standards and immediate reporting, in a single office visit during a patient’s regular exam. Once the patient’s fundus images have been captured and submitted to the EyeArt AI System, the detection results are available in a PDF report in less than 30 seconds.

The EyeArt AI system was developed with funding from the U.S. National Institutes of Health and is validated by the U.K. National Health Service. The EyeArt AI system has CE marking as a class IIb medical device in the European Union under the EU’s Medical Devices Regulation 2017/745 (“MDR”) for the detection of DR, AMD, and glaucomatous optic nerve damage. Additionally, the system has U.S. Food and Drug Administration 510(k) clearance and a Health Canada license for autonomous detection of DR. It is designed to be General Data Protection Regulation (GDPR) and Health Insurance Portability and Accountability Act of 1996 (HIPAA) compliant.

The EyeArt AI system is reimbursable by government and private payors in the U.S. under the Category 1 Current Procedural Terminology (CPT) code 92229.

Learn more about the EyeArt AI System by watching this video.

Media Inquiries:
Todd Stein
510-417-0612
Todd@toddsteincommunications.com