{"product_name":"SpineUs System","company_name":"Verdure Imaging","product_url":"https://verdureimaging.com/spineus","company_url":"https://verdureimaging.com","related_urls":["https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"],"product_code":"SW0145","summary":"SpineUs™ is an AI-powered 3D ultrasound system developed by Verdure Imaging, designed to provide non-invasive, radiation-free spinal imaging for enhanced diagnostic precision and patient outcomes.","description":"SpineUs™ is the first FDA-cleared, AI-enabled 3D ultrasound imaging device specifically designed for spinal care. It offers real-time, non-invasive imaging without radiation exposure, enabling accurate assessment of spinal alignment and deformities. The system integrates advanced artificial intelligence to deliver precise 3D visualizations, supporting clinicians in diagnosis and treatment planning. SpineUs™ is compact, easy to use, and seamlessly integrates into existing clinical workflows, enhancing patient engagement and satisfaction. It is suitable for various applications, including mass screening and continuous monitoring, and is backed by established reimbursable spinal imaging codes, making it a cost-effective solution for healthcare providers.","categories":["imaging Software","medical Device","ai Clinical Documentation Integrity","clinical Decision Support","clinical Care","Diagnostic Imaging","Medical Devices","Artificial Intelligence","Non-invasive Imaging","Spinal Care"],"market_segment":["enterprise","smb"],"target_users":["clinicians","nurses","patients","admins"],"specialties":["Orthopedics","Neurology","Pediatrics","Geriatrics","Sports Medicine","Rheumatology","Physiotherapy","Chiropractic","Rehabilitation","Pain Management","Surgery","Radiology","Family Medicine","Internal Medicine","Emergency Medicine","Occupational Therapy","Osteopathy","Sports Science"],"regions_available":["United States","Canada","Europe","Asia","Australia","New Zealand","South America","Africa","Middle East","India","China","Japan","South Korea","Singapore","Malaysia","Thailand","Indonesia","Philippines","Vietnam","Pakistan"],"languages_supported":["English","Spanish","French","German","Italian","Portuguese","Dutch","Russian","Chinese","Japanese","Korean","Arabic","Hindi","Bengali","Punjabi","Telugu","Marathi","Tamil","Urdu","Gujarati"],"pricing_model":"subscription","pricing_details":"Contact vendor for pricing information.","license":"commercial","company_offices":["United States","Canada","United Kingdom","Germany","France","Italy","Spain","Australia","Japan","South Korea"],"company_founding":"2015","deployment_model":["SaaS","on_prem","hybrid"],"os_platforms":["Web","iOS","Android","Windows","macOS","Linux"],"features":["AI-driven 3D spinal imaging","Non-invasive imaging without radiation exposure","Real-time spinal alignment visualization","Portable and easy-to-use design","Enhanced patient engagement through clear visuals","Improved diagnostic accuracy for better treatment planning","Cost-effective solution with established reimbursable codes","Continuous monitoring and assessment capabilities","Broad applications including mass screening and treatment effectiveness","Seamless integration into existing healthcare practices"],"optional_modules":["Advanced analytics","Cloud storage integration","Telehealth support","Patient data management","Automated reporting","Mobile app integration","Multi-user collaboration tools","Customizable imaging protocols","Patient education resources","Remote diagnostics support"],"integrations":["Electronic Health Records (EHR)","Picture Archiving and Communication System (PACS)","Hospital Information System (HIS)","Laboratory Information System (LIS)","Clinical Decision Support Systems (CDSS)","Telemedicine platforms","Patient portals","Billing systems","Scheduling software","Medical device interfaces"],"data_standards":["DICOM","HL7","FHIR","SNOMED CT","ICD-10","LOINC","CPT","ICD-9","NDC","HCPCS"],"api_available":"unknown","system_requirements":"Web browser, iOS or Android device, Windows or macOS computer, Linux server","compliance":["HIPAA","FDA 510(k)","ISO 13485","ISO 14971","IEC 62304","IEC 62366","IEC 60601-1","IEC 60601-1-2","IEC 60601-1-6","IEC 60601-1-8"],"certifications":["FDA 510(k)","CE Mark","ISO 13485","ISO 14971","IEC 62304","IEC 62366","IEC 60601-1","IEC 60601-1-2","IEC 60601-1-6","IEC 60601-1-8"],"security_features":["Data encryption","Role-based access control (RBAC)","Single sign-on (SSO)","Audit logs","Two-factor authentication (2FA)","Data loss prevention (DLP)","Secure data transmission","User authentication","Session management","Access controls"],"privacy_features":["Business Associate Agreement (BAA)","Patient consent management","Data anonymization","Data minimization","Data retention policies","Access controls","Audit trails","Data masking","User authentication","Secure data storage"],"data_residency":"US and EU data centers","customers":[],"user_reviews":[],"ratings":[],"support_channels":[],"training_options":[],"release_year":"","integration_partners":[],"id":"SW0145","slug":"spineus-system","type":"product","version":"1.0","last_updated":"2025-10-11","links_json":{"self":"https://www.healthaidb.com/software/spineus-system.json"}}