Eyenuk, a global artificial intelligence (AI) medical technology and services 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 (glaucoma).
The EyeArt AI system previously received both FDA clearance in the US and CE marking in the EU enabling its use for autonomous detection of diabetic retinopathy (DR), the leading cause of blindness among working-age adults globally. The new European Commission (EC) certification of the EyeArt AI system as a Class IIb medical device under the EU’s Medical Devices Regulation 2017/745 (“MDR”) allows Eyenuk customers in Europe to optionally detect AMD and glaucoma in addition to DR in a single exam using the same set of retinal images. The new certification also ensures continuous market access of the EyeArt AI system in the EU and comes at a time when the new regulation’s more stringent requirements and higher safety standards reportedly have many medical device companies considering exiting the EU market.
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 may help reduce the prevalence of vision-threatening eye disease.
“Achieving MDR certification is another major milestone for Eyenuk and a result of our early adaptation to the more stringent requirements of the new regulation,” said Kaushal Solanki, Chief Executive Officer and Founder of Eyenuk. “Moreover, this certification expanding our ability to market the EyeArt platform for two additional disease conditions in the EU reflects the flexibility of our AI-based platform and the depth of the clinical research conducted across the globe validating its effectiveness.”
Solanki continued, “DR, AMD, and glaucoma are all asymptomatic in their early stages. The sensitivity of the EyeArt AI algorithm, 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 eyecare 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 for DR globally, by far the most screenings by any autonomous AI system
- Growing the number of locations using the EyeArt AI system to more than 200 in 18 countries and 14 U.S. states
- 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