{"product_name":"AEYE-DS","company_name":"AEYE Health","product_url":"https://www.aeyehealth.com/aeye-diagnostic-screening","company_url":"https://www.aeyehealth.com","related_urls":["https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"],"product_code":"SW0226","summary":"AEYE-DS is an AI-powered diagnostic screening solution for diabetic retinopathy, enabling rapid, point-of-care detection using portable retinal cameras.","description":"AEYE-DS, developed by AEYE Health, is an FDA-cleared AI diagnostic system designed for autonomous detection of more-than-mild diabetic retinopathy in adults with diabetes. It operates with portable retinal cameras, requiring only one image per eye and rarely necessitating dilation, providing instant diagnostic results. The system is compatible with Topcon NW400 and Optomed Aurora cameras, facilitating flexible and accessible screening in various healthcare settings. AEYE-DS has demonstrated high sensitivity and specificity in clinical studies, with sensitivity ranging from 92% to 93% and specificity between 89% and 94%, depending on the camera used. The solution is reimbursable under CPT code 92229, addressing care gaps and improving quality metrics such as HEDIS scores and Star ratings. AEYE Health has partnered with organizations like Ford Medical to expand AEYE-DS's availability in pharmacies and non-acute centers, enhancing early detection and treatment of diabetic retinopathy. Additionally, AEYE-DS has been integrated into electronic medical record systems, such as at UMass Memorial Health, to streamline workflows and improve patient outcomes. The system's portability and ease of use make it suitable for home care settings, offering convenient screening options for patients.","categories":["diagnostic Support","clinical Care","patient Facing","administrative Operations","Diagnostic","Clinical","Patient-facing","Administrative"],"market_segment":["enterprise","smb","consumer"],"target_users":["clinicians","nurses","patients","admins","payers"],"specialties":["Diabetic Retinopathy","Ophthalmology"],"regions_available":["United States"],"languages_supported":["English"],"pricing_model":"subscription","pricing_details":"contact vendor","license":"commercial","company_offices":["United States","Israel"],"company_founding":"2019","deployment_model":["SaaS","on_prem","hybrid"],"os_platforms":["Web","iOS","Android","Windows","macOS","Linux"],"features":["Autonomous diabetic retinopathy screening","Single image per eye requirement","Instantaneous diagnostic results","Portable and cost-effective retinal cameras","Integration with electronic medical records (EMR)","FDA-cleared for use with Topcon NW400 and Optomed Aurora cameras","High sensitivity and specificity in clinical studies","Dedicated CPT code 92229 for AI diabetic retinopathy screening","Improvement in diabetic eye care adherence and quality measures"],"optional_modules":["Handheld device integration","Robotic tabletop camera integration"],"integrations":["Topcon NW400","Optomed Aurora","Electronic Medical Records (EMR) systems"],"data_standards":["FHIR","HL7 v2","DICOM","SNOMED","ICD-10"],"api_available":"unknown","system_requirements":"Topcon NW400 or Optomed Aurora camera, internet connectivity","compliance":["HIPAA","FDA 510(k) clearance","SOC 2 Type II certification"],"certifications":["FDA 510(k) clearance","SOC 2 Type II certification"],"security_features":["Encryption","RBAC","SSO/SAML","audit logs","2FA","DLP"],"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":"SW0226","slug":"aeye-ds","type":"product","version":"1.0","last_updated":"2025-10-11","links_json":{"self":"https://www.healthaidb.com/software/aeye-ds.json"}}