LOS ANGELES, Jan. 31, 2023 (GLOBE NEWSWIRE) — Eyenuk, a worldwide synthetic intelligence (AI) digital well being firm, and the chief in real-world purposes for AI Eye Screening™ and AI Predictive Biomarkers™, has been accredited to market its EyeArt® AI eye screening system in the European Union for the new makes use of of detecting age-related macular degeneration (AMD) and glaucomatous optic nerve harm (an indication of glaucoma).
The EyeArt AI system (model 3.0) has been granted a brand new European Fee (EC) certification as a Class IIb medical gadget below the EU’s Medical Units Regulation 2017/745 (“MDR”) and is meant to detect indicators of diabetic retinopathy (DR) (together with diabetic macular edema), AMD, and glaucomatous optic nerve harm in sufferers in danger of imaginative and prescient loss utilizing computerized evaluation of photographs of the retina. The EyeArt AI system was beforehand accredited in the EU for the detection of DR together with diabetic macular edema.
This EC Certification makes the EyeArt AI system the first and solely autonomous AI resolution with Class IIb MDR CE marking for the automated detection of all three eye ailments and will enable Eyenuk clients in the EU to detect the ailments in a single examination utilizing the similar set of retinal photographs. The EyeArt AI system can also be the first and solely system that’s each CE Marked for the detection of the three ailments in addition to FDA-cleared in the United States for the detection of DR, the main trigger of blindness amongst working-age adults.
The EyeArt AI system tremendously expands the availability of vision-saving eye screenings by making automated AI analysis and coordination of care potential in major care medical practices with out the want for a specialist’s assessment. The system is built-in with retinal imaging cameras and will be operated by scientific assist workers to generate an in depth screening report in lower than 30 seconds. In areas with restricted entry to ophthalmologists, its means to detect a number of eye ailments with a single examination may help cut back imaginative and prescient loss from these blinding eye ailments.
Malavika Bhaskaranand, Head of Regulatory and Medical 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 Govt 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 12 months of Breakthroughs for Eyenuk
The EC Certification of the EyeArt AI system caps a 12 months of vital scientific and enterprise milestones for Eyenuk. The corporate’s accomplishments in 2022 included:
- Securing $26 million in a Collection A financing spherical, bringing the firm’s whole funding to over $43 million
- Reaching the new milestone of 70,000 sufferers screened utilizing the EyeArt AI system globally since its FDA clearance in August 2020, by far the most screenings by any FDA-cleared autonomous AI system
- Rising the quantity of places utilizing the EyeArt AI system to greater than 200 in 18 nations and all through the US
- Publication of a serious peer-reviewed research discovering that the EyeArt AI system is way extra delicate in figuring out referable DR than dilated eye exams by ophthalmologists and retina specialists
- Successful Juniper Analysis’s Future Digital Well being award for the “Best Digital Diagnostics Solution”
- Being named a finalist for the UCSF Digital Well being Award
About Eyenuk, Inc.
Eyenuk, Inc. is a worldwide synthetic intelligence (AI) digital well being firm and the chief in real-world AI Eye Screening™ for autonomous illness detection and AI Predictive Biomarkers™ for danger evaluation and illness surveillance. Eyenuk is on a mission to display each eye in the world to make sure well timed analysis of life- and vision-threatening ailments, together with diabetic retinopathy, glaucoma, age-related macular degeneration, stroke danger, cardiovascular danger, and Alzheimer’s illness. Discover Eyenuk on-line on its web site, Twitter, Fb, and LinkedIn.
About the EyeArt AI System
The EyeArt AI system supplies totally autonomous screening for diabetic retinopathy (DR), age-related macular degeneration (AMD), and glaucomatous optic nerve harm, together with retinal imaging, primarily based on worldwide scientific requirements and quick reporting, in a single workplace go to throughout a affected person’s common examination. As soon as the affected person’s fundus photographs have been captured and submitted to the EyeArt AI System, the detection outcomes can be found in a PDF report in lower than 30 seconds.
The EyeArt AI system was developed with funding from the U.S. Nationwide Institutes of Well being and is validated by the U.Okay. Nationwide Well being Service. The EyeArt AI system has CE marking as a category IIb medical gadget in the European Union below the EU’s Medical Units Regulation 2017/745 (“MDR”) for the detection of DR, AMD, and glaucomatous optic nerve harm. Moreover, the system has U.S. Meals and Drug Administration 510(okay) clearance and a Well being Canada license for autonomous detection of DR. It’s designed to be Common Knowledge Safety Regulation (GDPR) and Well being Insurance coverage Portability and Accountability Act of 1996 (HIPAA) compliant.
The EyeArt AI system is reimbursable by authorities and personal payors in the U.S. below the Class 1 Present Procedural Terminology (CPT) code 92229.
Study extra about the EyeArt AI System by watching this video.
Media Inquiries:
Todd Stein
510-417-0612
Todd@toddsteincommunications.com
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