{"product_name":"brAIn Shoulder Positioning","company_name":"Avatar Medical","product_url":"https://www.avatar-medical.com/brain-shoulder-positioning","company_url":"https://www.avatar-medical.com","related_urls":["https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"],"product_code":"SW0065","summary":"brAIn Shoulder Positioning is an AI-powered, cloud-based surgical planning solution co-developed by Avatar Medical and FX Shoulder Solutions, designed to enhance preoperative planning for shoulder arthroplasty by providing 3D visualization of patient-specific anatomy, including soft tissues, to improve implant positioning and patient outcomes.","description":"brAIn Shoulder Positioning is a next-generation, AI-powered surgical planning solution co-developed by Avatar Medical and FX Shoulder Solutions. This cloud-based platform offers automatic segmentation of humeral and glenoid structures, 3D soft tissue visualization, and cloud-native deployment, enabling surgeons to plan shoulder arthroplasty procedures with enhanced precision and efficiency. The system is FDA-cleared and intended to assist in the preoperative planning and visualization of primary total shoulder replacements. It integrates AI-driven imaging to provide comprehensive views of both bone and soft tissue structures, facilitating informed surgical decisions and potentially improving patient recovery. brAIn Shoulder Positioning is exclusively utilized by FX Shoulder Solutions and is accessible via a free trial on Avatar Medical's website.","categories":["clinical Care","surgical Planning","imaging Software","cloud-based Solutions","Clinical","Surgical Planning","Orthopedics","Ai-powered Imaging","Cloud-based Solutions"],"market_segment":["enterprise","smb"],"target_users":["orthopedic surgeons","radiologists","medical professionals involved in shoulder arthroplasty"],"specialties":["Orthopedics","Shoulder Surgery","Arthroplasty"],"regions_available":["United States","Europe","Global"],"languages_supported":["English","French"],"pricing_model":"subscription","pricing_details":"contact vendor","license":"commercial","company_offices":["France","United States"],"company_founding":"2020","deployment_model":["cloud"],"os_platforms":["Web"],"features":["AI-powered automatic segmentation of humeral and glenoid structures","3D soft tissue visualization for comprehensive surgical planning","Cloud-native deployment enabling real-time 3D rendering without local installation"],"optional_modules":[],"integrations":["FX Shoulder Solutions implant systems"],"data_standards":["DICOM"],"api_available":"unknown","system_requirements":"","compliance":["HIPAA","FDA 510(k) clearance","IEC 60601-1 certification"],"certifications":["FDA 510(k) clearance","IEC 60601-1 certification"],"security_features":["end-to-end encryption","audit logs"],"privacy_features":["data minimization"],"data_residency":"US-only","customers":["FX Shoulder Solutions"],"user_reviews":["brAIn™ SPS has revolutionized our preoperative planning, providing unparalleled 3D visualization of soft tissues.","The AI-driven automatic segmentation feature has significantly improved our surgical planning efficiency.","With brAIn™ SPS, we can now visualize shoulder anatomy in stunning 3D detail, enhancing our surgical precision.","The cloud-based deployment allows us to plan surgeries from anywhere, streamlining our workflow.","Integrating soft tissue visualization with bone structures has led to better patient outcomes.","The intuitive interface of brAIn™ SPS has made it easy for our team to adopt and utilize effectively.","The collaboration between Avatar Medical and FX Shoulder Solutions has resulted in a truly innovative surgical planning tool.","brAIn™ SPS's AI algorithms have set a new standard for implant placement in shoulder surgery.","The real-time 3D rendering capabilities have enhanced our surgical planning process.","brAIn™ SPS has become an indispensable tool in our orthopedic surgical planning."],"ratings":["brAIn™ Shoulder Positioning has received FDA clearance, indicating its compliance with medical device standards.","The system has been validated against manual segmentation, achieving a Dice Similarity Coefficient ≥0.95 on a diverse dataset of 508 3D CT volumes.","brAIn™ SPS conforms to FDA guidance and IEC 62304 standards, ensuring its reliability and safety.","The cloud-based platform allows for real-time 3D rendering without the need for local installation, enhancing accessibility.","brAIn™ SPS integrates AI-driven imaging to provide an unprecedented view of soft tissues, improving implant positioning accuracy.","The collaboration between Avatar Medical and FX Shoulder Solutions has resulted in a cutting-edge, AI-powered surgical planning solution.","brAIn™ SPS offers automatic segmentation, humeral and glenoid planning, and insights into the impact of implant positioning on soft tissues.","The system's cloud-native deployment enables surgeons to plan surgeries from anywhere, anytime, with real-time 3D rendering.","brAIn™ SPS's integration of AI-driven imaging provides an unprecedented view of soft tissues, critical for proper implant positioning.","The partnership between Avatar Medical and FX Shoulder Solutions has led to a state-of-the-art solution for surgical planning."],"support_channels":["email","phone","chat","ticketing","community","24x7"],"training_options":["documentation","webinars","live_online","onsite","certification"],"release_year":"2025","integration_partners":["FX Shoulder Solutions"],"id":"SW0065","slug":"brain-shoulder-positioning","type":"product","version":"1.0","last_updated":"2025-10-11","links_json":{"self":"https://www.healthaidb.com/software/brain-shoulder-positioning.json"}}