{"product_name":"LumineticsCore","company_name":"Digital Diagnostics","product_url":"https://www.digitaldiagnostics.com/products/","company_url":"https://www.digitaldiagnostics.com","related_urls":["https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"],"product_code":"SW0422","summary":"LumineticsCore® is an FDA-cleared AI diagnostic system that autonomously detects diabetic retinopathy, including macular edema, at the point-of-care, enhancing early diagnosis and treatment accessibility for individuals with diabetes.","description":"LumineticsCore® is an AI-driven diagnostic platform developed by Digital Diagnostics to identify diabetic retinopathy and macular edema in patients with diabetes. It operates autonomously, analyzing retinal images to provide diagnostic results without the need for specialist interpretation, thereby facilitating early detection and intervention. The system has been integrated into various healthcare settings, including primary care offices and lab service centers, to improve access to eye care for diabetic patients. It has been validated through extensive clinical trials to ensure accuracy and patient safety. The rebranding from IDx-DR to LumineticsCore® reflects the company's mission to make AI diagnostics more approachable and human-centric.","categories":["diagnostic Support","clinical Care","patient Facing","Diagnostic","Clinical","Patient-facing"],"market_segment":["enterprise","smb","consumer"],"target_users":["clinicians","patients","admins"],"specialties":["Diabetic Retinopathy","Macular Edema"],"regions_available":["United States"],"languages_supported":["English"],"pricing_model":"subscription","pricing_details":"contact vendor","license":"commercial","company_offices":["United States"],"company_founding":"2018","deployment_model":["SaaS","point-of-care"],"os_platforms":["Web"],"features":["Autonomous AI diagnosis of diabetic retinopathy (including macular edema)","Point-of-care retinal image analysis","Rapid results at time of encounter (typically seconds)","Guided high-quality fundus image capture workflow for operators","FDA De Novo clearance (first autonomous AI diagnostic for DR)","Works with standard fundus cameras/retinal imaging","Provides binary output (mtmDR detected/not detected) and referral recommendation","Designed for use by non-eye care providers in primary care settings","Supports care gap closure for diabetes eye exams","Deployed in health systems and ambulatory settings","Regulatory and compliance support (HIPAA)","Customer training and implementation services"],"optional_modules":[],"integrations":["Topcon NW400","Epic"],"data_standards":["FHIR","HL7 v2","DICOM","SNOMED","ICD-10"],"api_available":"unknown","system_requirements":"","compliance":["HIPAA"],"certifications":["FDA De Novo clearance (K213037)","ISO 13485:2016"],"security_features":["Encryption","RBAC","SSO/SAML","Audit logs","2FA"],"privacy_features":["BAA available","Consent management","Anonymization","Data minimization"],"data_residency":"US/EU regions","customers":[],"user_reviews":[],"ratings":[],"support_channels":[],"training_options":[],"release_year":"","integration_partners":[],"id":"SW0422","slug":"lumineticscore","type":"product","version":"1.0","last_updated":"2025-10-11","links_json":{"self":"https://www.healthaidb.com/software/lumineticscore.json"}}