{"product_name":"Pulse","company_name":"NuVasive","product_url":"https://www.nuvasive.com/surgical-solutions/pulse/","company_url":"https://www.nuvasive.com","related_urls":["https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"],"product_code":"SW0586","summary":"Pulse is an integrated technology platform by NuVasive designed to enhance spine surgery by combining multiple technologies into a single system, aiming to improve surgical efficiency and patient outcomes.","description":"NuVasive's Pulse platform integrates neuromonitoring, surgical planning, rod bending, radiation reduction, imaging, and navigation functions into a single system. It is designed to improve workflow, reduce surgical variability, and increase reproducibility of surgical outcomes in spine procedures. The platform supports a wide range of spine surgeries, from fusions to complex corrections, and is engineered to be utilized in 100% of spine surgeries. Pulse's modular architecture allows for flexible technology packages, enabling surgeons to select tools tailored to specific pathologies in spine surgery procedures. Additionally, Pulse's wireless functionality allows operating room staff to access technologies independently, facilitating a seamless, optimized workflow. The platform also features an extensible architecture to support future applications, including robotics and smart tools. Pulse has received FDA 510(k) clearance and CE Mark approval, indicating its compliance with regulatory standards for medical devices. It is currently available in targeted global regions, with clinical evaluations underway in multiple countries throughout Europe. The platform is designed to be utilized in 100% of spine procedures, from open to less invasive techniques, enhancing a surgeon's capabilities to make better, more informed clinical decisions for their patients.","categories":["clinical Care","administrative Operations","patient Facing","diagnostic Support","surgical Care","clinical Workflow Automation","imaging Software","wayfinding","neuromonitoring","radiation Therapy","surgical Planning","robotics","software Tool","software Development","regulatory Compliance","health Equity","clinical Assessment Tools","Clinical","Administrative","Patient-facing","Diagnostic","Surgical","Workflow","Imaging","Navigation","Neuromonitoring","Radiation Reduction","Rod Bending","Surgical Planning","Robotics","Smart Tools","Modular Architecture","Fda 510(k) Clearance","Ce Mark Approval","Global Availability","Clinical Evaluations","Spine Procedures"],"market_segment":["enterprise","smb","consumer"],"target_users":["clinicians","surgeons","operating room staff","hospital administrators","patients"],"specialties":["Spine Surgery","Orthopedics","Neurosurgery","Minimally Invasive Surgery","Robotic-assisted Surgery","Surgical Planning","Imaging","Navigation","Neuromonitoring","Radiation Reduction","Rod Bending","Surgical Workflow","Modular Technology","Fda 510(k) Clearance","Ce Mark Approval","Global Availability","Clinical Evaluations","Spine Procedures","Surgical Efficiency","Patient Outcomes"],"regions_available":["United States","Europe","Global"],"languages_supported":["English","German","French","Spanish","Italian","Dutch","Swedish","Danish","Norwegian","Finnish","Portuguese","Greek","Turkish","Russian","Polish","Czech","Hungarian","Romanian","Bulgarian","Serbian","Croatian"],"pricing_model":"enterprise_quote","pricing_details":"Contact vendor for pricing information.","license":"commercial","company_offices":["United States","Germany","France","United Kingdom","Italy","Spain","Netherlands","Sweden","Denmark","Norway"],"company_founding":"1997","deployment_model":["on_prem"],"os_platforms":["Windows"],"features":["2D and 3D imaging and navigation","Integrated Global Alignment (iGA) for surgical planning","Neuromonitoring with automatic nerve detection","Radiation reduction through LessRay technology","Patient-specific rod bending with Bendini technology","Modular architecture for flexible technology packages","Wireless connectivity for seamless team collaboration","Compatibility with Siemens Healthineers' Cios Spin 3D mobile C-arm"],"optional_modules":["Spine robotics module"],"integrations":["Siemens Healthineers' Cios Spin 3D mobile C-arm"],"data_standards":["HL7","FHIR","DICOM","SNOMED","ICD-10"],"api_available":"unknown","system_requirements":"Windows OS","compliance":["HIPAA","FDA 510(k) clearance","CE mark certification"],"certifications":["FDA 510(k) clearance","CE mark certification"],"security_features":["Data encryption at rest and in transit","Role-based access control (RBAC)","Audit logs","2FA"],"privacy_features":["BAA available","Consent management","Data anonymization","Data minimization"],"data_residency":"US-only","customers":[],"user_reviews":[],"ratings":[],"support_channels":[],"training_options":[],"release_year":"","integration_partners":[],"id":"SW0586","slug":"pulse","type":"product","version":"1.0","last_updated":"2025-10-11","links_json":{"self":"https://www.healthaidb.com/software/pulse.json"}}