Eyenuk

Eyenuk is a company that specializes in artificial intelligence (AI) for eye screening. Its flagship product, the EyeArt system, is the first FDA-cleared AI technology for the autonomous detection of both more-than-mild and vision-threatening diabetic retinopathy. The EyeArt system has received US FDA clearance, CE marking as a class IIb medical device in the European Union, and a Health Canada license. It provides automated diabetic retinopathy screening without the need for expert human grading or eye dilation, autonomously analyzing retinal images and delivering an easy-to-read report in under 60 seconds. The system incorporates deep learning and image analysis algorithms to assess image quality and detect disease, achieving high accuracy with 96% sensitivity and 88% specificity for more-than-mild diabetic retinopathy, and 97% sensitivity and 90% specificity for vision-threatening diabetic retinopathy. Validated in real-world clinical environments with over half a million patient visits globally, the EyeArt system is designed to be easy to use and can be employed by nurses or technicians. It integrates seamlessly with clinical workflows and third-party software systems like EHR/EMR and PACS through its RESTful API. Supported by prestigious National Eye Institute grants totaling over $4.1 million USD, the EyeArt system has been used on five continents and validated by the UK National Health Service in studies involving over 20,000 patients. The system is HIPAA and GDPR compliant, ensuring high levels of security and privacy. It is designed to work effectively with the image quality commonly encountered in diabetes patients and is indicated for use with Canon CR-2 AF, Canon CR-2 Plus AF, and Topcon NW400 cameras. The EyeArt system makes in-clinic, real-time diabetic retinopathy screening possible for primary care practices, diabetes centers, and optometric offices, enabling quick and accurate identification of referable diabetic retinopathy patients during regular exams.