{"product_name":"aprevo Digital Segmentation","company_name":"Carlsmed","product_url":"https://carlsmed.com/how-it-works/","company_url":"https://carlsmed.com","related_urls":["https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"],"product_code":"SW0295","summary":"aprevo Digital Segmentation is Carlsmed's AI-driven platform that personalizes spine fusion surgeries to enhance patient outcomes.","description":"aprevo Digital Segmentation is an AI-enabled platform developed by Carlsmed to personalize spine fusion surgeries. It integrates pre-operative 3D surgical planning, intra-operative advanced visualization, and post-operative data analysis to create patient-specific surgical plans and devices, aiming to improve surgical precision and long-term outcomes. The platform has received FDA clearance for lumbar and cervical spinal fusion indications in the U.S.","categories":["clinical Care","diagnostic Support","patient Facing","Clinical","Diagnostic","Patient-facing"],"market_segment":["enterprise","smb"],"target_users":["clinicians","surgeons","patients"],"specialties":["Orthopedics","Neurosurgery"],"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"],"os_platforms":["Web","iOS","Android"],"features":["AI-enabled 3D surgical planning","Personalized surgical plans and devices","3D patient data integration","Spinopelvic parameter classifications","Normative range targets","Post-operative data analysis","3D correction and precision alignment","myaprevo® app for 3D plan and device visualization","Patient-specific device design","3D printing of personalized devices","Sterile device delivery for implantation","Post-operative image analysis for goal confirmation"],"optional_modules":["myaprevo® app"],"integrations":["CT scan imaging systems"],"data_standards":["DICOM"],"api_available":"unknown","system_requirements":"","compliance":["HIPAA","FDA 510(k) clearance for lumbar and cervical spinal fusion indications"],"certifications":["FDA 510(k) clearance for lumbar and cervical spinal fusion indications"],"security_features":["Data encryption","Role-based access control (RBAC)","Audit logs","Two-factor authentication (2FA)"],"privacy_features":["Business Associate Agreement (BAA) availability","Data anonymization","Data minimization"],"data_residency":"US-only","customers":[],"user_reviews":[],"ratings":[],"support_channels":[],"training_options":[],"release_year":"","integration_partners":[],"id":"SW0295","slug":"aprevo-digital-segmentation","type":"product","version":"1.0","last_updated":"2025-10-11","links_json":{"self":"https://www.healthaidb.com/software/aprevo-digital-segmentation.json"}}