{"product_name":"EyeArt","company_name":"Eyenuk","product_url":"https://www.eyenuk.com/us-en/products/eyeart/","company_url":"https://www.eyenuk.com","related_urls":["https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"],"product_code":"SW0345","summary":"EyeArt is an AI-powered system developed by Eyenuk for autonomous diabetic retinopathy screening, providing rapid, in-clinic detection without the need for expert human grading or eye dilation.","description":"EyeArt is an AI-driven system designed for the autonomous detection of diabetic retinopathy (DR). It enables rapid, in-clinic screening by analyzing retinal images and generating detailed reports in under 60 seconds, facilitating timely diagnosis and referral decisions. The system has been extensively validated, demonstrating high sensitivity and specificity in real-world clinical settings. EyeArt is FDA-cleared, CE-marked as a Class IIb medical device in the European Union, and holds a Health Canada license, supporting its use in various healthcare settings globally.","categories":["diagnostic Support","clinical Care","patient Facing","Diagnostic","Clinical","Patient-facing"],"market_segment":["enterprise","smb"],"target_users":["clinicians","nurses","patients","admins"],"specialties":["Diabetic Retinopathy","Ophthalmology","Optometry"],"regions_available":["United States","European Union","Canada","Latin America","Middle East"],"languages_supported":["English","Spanish","French","German","Italian","Portuguese","Dutch","Arabic","Hebrew","Turkish","Russian","Chinese","Japanese","Korean","Hindi","Bengali","Punjabi","Telugu","Marathi","Tamil","Urdu"],"pricing_model":"subscription","pricing_details":"Contact vendor for pricing information.","license":"commercial","company_offices":["United States","United Kingdom","Germany","India","China","Japan","Brazil","Mexico","South Africa","Australia"],"company_founding":"2010","deployment_model":["SaaS","on_prem","hybrid"],"os_platforms":["Web"],"features":["Automated diabetic retinopathy screening","Image quality feedback","International Clinical DR grading","Single office visit screening","Rapid result generation (under 1 minute)","Integration with retinal imaging cameras","Cloud-based design","HIPAA compliance","GDPR compliance","SOC2 Type II compliance","ISO 13485:2016 certification","MDSAP certification"],"optional_modules":["Age-related macular degeneration detection","Glaucomatous optic nerve damage detection"],"integrations":["Canon CR-2 AF","Canon CR-2 Plus AF","Topcon NW400","EHR/EMR systems","PACS systems"],"data_standards":["DICOM","HL7","FHIR"],"api_available":"yes","system_requirements":"Canon CR-2 AF, Canon CR-2 Plus AF, Topcon NW400 cameras","compliance":["HIPAA","GDPR","SOC2 Type II","ISO 13485:2016","MDSAP"],"certifications":["FDA 510(k)","CE Marking (Class IIb)","Health Canada license"],"security_features":["Encryption","RBAC","Audit logs","2FA"],"privacy_features":["BAA available","Consent management","Anonymization","Data minimization"],"data_residency":"US/EU regions","customers":["Diabetes Clinic in Bad Mergentheim, Germany"],"user_reviews":["EyeArt has been instrumental in our clinic's workflow, providing rapid and accurate diabetic retinopathy screenings."],"ratings":["4.8/5 on G2.com"],"support_channels":["email","phone","chat","ticketing","community","24x7"],"training_options":["documentation","webinars","live_online","onsite","certification"],"release_year":"2018","integration_partners":["Canon CR-2 AF","Canon CR-2 Plus AF","Topcon NW400"],"id":"SW0345","slug":"eyeart","type":"product","version":"1.0","last_updated":"2025-10-11","links_json":{"self":"https://www.healthaidb.com/software/eyeart.json"}}