Eyenuk
Eyenuk specializes in AI for eye screening, with its EyeArt system being the first FDA-cleared AI technology for autonomous detection of diabetic retinopathy.
Company Specialization in AI for Eye Screening
Eyenuk specializes in developing artificial intelligence (AI) technologies specifically for eye screening. Their flagship product, EyeArt, is designed to provide automated diabetic retinopathy screening. The system uses deep learning and image analysis algorithms to analyze retinal images, allowing for the detection of more than mild and vision-threatening diabetic retinopathy without the need for expert human grading or eye dilation.
EyeArt FDA Clearance and International Certifications
EyeArt is the first AI technology to receive U.S. FDA clearance for the autonomous detection of both more than mild and vision-threatening diabetic retinopathy. It also holds CE marking as a class IIb medical device in the European Union and a Health Canada license. These certifications reflect the system's compliance with rigorous international standards, ensuring its reliability and safety for clinical use.
Automated Diabetic Retinopathy Screening
The EyeArt system autonomously analyzes retinal images and provides an easy-to-read report in under 60 seconds. This rapid analysis includes assessing image quality and detecting signs of diabetic retinopathy, enabling automated screening in various healthcare settings. The system supports seamless integration with clinical workflows through its RESTful API, making it compatible with third-party software and systems such as EHR/EMR and PACS.
Global Validation and Clinical Studies
EyeArt has been validated in real-world clinical environments with over half a million patient visits globally. The system has achieved high sensitivity (96% for detecting more-than-mild diabetic retinopathy and 97% for vision-threatening diabetic retinopathy) and high specificity (88% and 90%, respectively). Independent validations by organizations such as the UK NHS demonstrate its accuracy and reliability, with one UK NHS study involving over 30,000 patients.
Ease of Use and Integration
Designed for ease of use, the EyeArt system can be employed by nurses or technicians without requiring expert human grading. It supports multiple camera models, including Canon CR-2 AF, Canon CR-2 Plus AF, and Topcon NW400, making it adaptable to various clinical environments. This capability enables in-clinic, real-time screening during regular patient exams, facilitating quicker identification and referral of diabetic retinopathy cases.