Eyenuk Secures European Union Certification For Autonomous AI-Powered Detection Of Age-Associated Macular Degeneration And Glaucoma
Eyenuk, a world synthetic intelligence (AI) medical expertise and providers 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 within the European Union for the brand new makes use of of detecting age-related macular degeneration (AMD) and glaucomatous optic nerve harm (glaucoma).
The EyeArt AI system beforehand obtained each FDA clearance within the US and CE marking within the EU enabling its use for autonomous detection of diabetic retinopathy (DR), the main reason for blindness amongst working-age adults globally. The brand new European Fee (EC) certification of the EyeArt AI system as a Class IIb medical gadget beneath the EU’s Medical Units Regulation 2017/745 (“MDR”) permits Eyenuk prospects in Europe to optionally detect AMD and glaucoma along with DR in a single examination utilizing the identical set of retinal photos. The brand new certification additionally ensures steady market entry of the EyeArt AI system within the EU and comes at a time when the brand new regulation’s extra stringent necessities and better security requirements reportedly have many medical gadget corporations contemplating exiting the EU market.
The EyeArt AI system drastically expands the provision of vision-saving eye screenings by making automated AI analysis and coordination of care potential in main care medical practices with out the necessity for a specialist’s evaluate. The system is built-in with retinal imaging cameras and could be operated by medical help workers to generate an in depth screening report in lower than 30 seconds. In areas with restricted entry to ophthalmologists, its skill to detect a number of eye ailments with a single examination might assist cut back the prevalence of vision-threatening eye illness.
“Reaching MDR certification is one other main milestone for Eyenuk and a results of our early adaptation to the extra stringent necessities of the brand new regulation,” stated Kaushal Solanki, Chief Government Officer and Founding father of Eyenuk. “Furthermore, this certification increasing our skill to market the EyeArt platform for 2 further illness situations within the EU displays the flexibleness of our AI-based platform and the depth of the medical analysis carried out throughout the globe validating its effectiveness.”
Solanki continued, “DR, AMD, and glaucoma are all asymptomatic of their early levels. The sensitivity of the EyeArt AI algorithm, and its skill to be delivered and not using a specialist, makes it simpler to catch the ailments early and to take preventative measures to guard the imaginative and prescient of those sufferers. We sit up for the chance to forge new partnerships with world-class hospitals and eyecare establishments in Europe to assist protect the eyesight of hundreds of thousands throughout the continent with these ailments.”
EC Certification Caps Yr of Breakthroughs for Eyenuk
The EC Certification of the EyeArt AI system caps a yr of serious medical and enterprise milestones for Eyenuk. The corporate’s accomplishments in 2022 included:
- Securing $26 million in a Sequence A financing spherical, bringing the corporate’s whole funding to over $43 million
- Reaching the brand new milestone of 70,000 sufferers screened for DR globally, by far probably the most screenings by any autonomous AI system
- Rising the variety of areas utilizing the EyeArt AI system to greater than 200 in 18 nations and 14 U.S. states
- Publication of a main 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 “Finest Digital Diagnostics Resolution”
- Being named a finalist for the UCSF Digital Well being Award