{"id":33394,"date":"2023-01-31T17:11:33","date_gmt":"2023-01-31T12:11:33","guid":{"rendered":"http:\/\/myanmarnewsgazette.com\/?guid=583ff39789ba696f03ecaaa7ac942495"},"modified":"2023-01-31T17:11:33","modified_gmt":"2023-01-31T12:11:33","slug":"eyenuk-secures-the-first-european-union-mdr-certification-for-autonomous-ai-detection-of-diabetic-retinopathy-age-related-macular-degeneration-and-glaucoma","status":"publish","type":"post","link":"https:\/\/myanmarnewsgazette.com\/eyenuk-secures-the-first-european-union-mdr-certification-for-autonomous-ai-detection-of-diabetic-retinopathy-age-related-macular-degeneration-and-glaucoma\/","title":{"rendered":"Eyenuk Secures the First European Union MDR Certification for Autonomous AI Detection of Diabetic Retinopathy, Age-Related Macular Degeneration, and Glaucoma"},"content":{"rendered":"
LOS ANGELES, Jan. 31, 2023 (GLOBE NEWSWIRE) — Eyenuk<\/a>, 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\u00ae 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).<\/p>\n The EyeArt <\/em>AI system (version 3.0) has been granted a new European Commission (EC) certification as a Class IIb medical device under the EU\u2019s Medical Devices Regulation 2017\/745 (\u201cMDR\u201d) 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<\/em> AI system was previously approved in the EU for the detection of DR including diabetic macular edema.<\/p>\n This EC Certification makes the EyeArt<\/em> 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<\/em> 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.<\/p>\n The EyeArt<\/em> 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\u2019s 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.<\/p>\n Malavika Bhaskaranand, Head of Regulatory and Clinical Affairs at Eyenuk<\/strong>, commented, \u201cAchieving 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<\/em> AI system.\u201d<\/p>\n Kaushal Solanki, Chief Executive Officer and Founder of Eyenuk<\/strong>, commented, \u201cThis EC certification multiplies our impact in two ways. First, our autonomous AI can now help many more patients at risk of vision loss \u2013 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.\u201d<\/p>\n Solanki continued, \u201cDR, AMD, and glaucoma are all asymptomatic in their early stages. The high sensitivity of the EyeArt<\/em> 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.\u201d<\/p>\n EC Certification Caps Year of Breakthroughs for Eyenuk<\/strong><\/p>\n The EC Certification of the EyeArt<\/em> AI system caps a year of significant clinical and business milestones for Eyenuk. The company\u2019s accomplishments in 2022 included:<\/p>\n About Eyenuk, Inc. <\/strong><\/p>\n 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\u2019s disease. Find Eyenuk online on its website<\/a>, Twitter<\/a>, Facebook<\/a>, and LinkedIn<\/a>.<\/p>\n About the <\/strong>EyeArt<\/em><\/strong> AI System <\/strong><\/p>\n The EyeArt<\/em><\/a> 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\u2019s regular exam. Once the patient\u2019s fundus images have been captured and submitted to the EyeArt<\/em> AI System, the detection results are available in a PDF report in less than 30 seconds.<\/p>\n The EyeArt<\/em> 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<\/em> AI system has CE marking as a class IIb medical device in the European Union under the EU\u2019s Medical Devices Regulation 2017\/745 (\u201cMDR\u201d) 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.<\/p>\n The EyeArt<\/em> AI system is reimbursable by government and private payors in the U.S. under the Category 1 Current Procedural Terminology (CPT) code 92229.<\/p>\n Learn more about the EyeArt<\/em><\/a> AI System\u00a0by watching this video<\/a>.<\/p>\n\n