{"product_name":"Volta AF-Xplorer","company_name":"Volta Medical","product_url":"https://www.volta-medical.com","company_url":"https://www.volta-medical.com","related_urls":["https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"],"product_code":"SW0028","summary":"Volta AF-Xplorer is an AI-driven electrophysiology mapping system designed to assist electrophysiologists in diagnosing and treating atrial fibrillation (AF).","description":"Volta AF-Xplorer leverages artificial intelligence to analyze electrophysiology data, providing real-time insights to enhance the precision and efficiency of AF procedures. It integrates seamlessly with existing electrophysiology equipment, offering advanced mapping capabilities and decision support tools to improve patient outcomes.","categories":["clinical Care","diagnostic Support","patient Facing","Clinical","Diagnostic","Patient-facing"],"market_segment":["enterprise"],"target_users":["electrophysiologists","cardiologists","medical device technicians"],"specialties":["Cardiology","Electrophysiology"],"regions_available":["United States","Europe"],"languages_supported":["English","French","German"],"pricing_model":"enterprise_quote","pricing_details":"Contact vendor for pricing information.","license":"commercial","company_offices":["France","United States"],"company_founding":"2018","deployment_model":["SaaS","on_prem","hybrid"],"os_platforms":["Web","iOS","Android","Windows","macOS","Linux"],"features":["AI-assisted mapping and decision-support system","Real-time detection of dispersed electrograms (EGMs)","Annotation of regions of interest in near real-time","Integration with existing electrophysiology recording systems","Integration with 3D mapping/navigation systems","Integration with mapping catheters","Automated tagging of regions of interest","Compatibility with Abbott Laboratories’ EnSite X mapping system","Compatibility with Biosense Webster’s Octaray multi-polar mapping catheter","Standardized approach to targeting dispersed EGMs","Enhanced workflow for electrophysiologists","Real-time access to expert electrophysiologist techniques","Tailored and intuitive workflow","Support for complex atrial fibrillation (AF) and atrial tachycardia (AT) procedures","FDA 510(k) clearance","CE Mark approval","Integration with GE HealthCare’s Prucka 3 and CardioLab EP Recording system","Support for catheter ablation procedures","Enhanced performance and streamlined workflows for electrophysiologists"],"optional_modules":["Advanced analytics","Remote monitoring","Data visualization tools","Patient management integration","Clinical decision support","Reporting and documentation tools","Training and simulation modules","Telemedicine integration","Regulatory compliance tracking","Research and development tools"],"integrations":["Abbott Laboratories’ EnSite X mapping system","Biosense Webster’s Octaray multi-polar mapping catheter","GE HealthCare’s Prucka 3","GE HealthCare’s CardioLab EP Recording system"],"data_standards":["FHIR","HL7 v2","DICOM","SNOMED","ICD-10"],"api_available":"unknown","system_requirements":"Compatible with existing electrophysiology recording systems, 3D mapping/navigation systems, and mapping catheters","compliance":["HIPAA","GDPR","HITECH","SOC 2","ISO 27001"],"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":["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":"SW0028","slug":"volta-af-xplorer","type":"product","version":"1.0","last_updated":"2025-10-11","links_json":{"self":"https://www.healthaidb.com/software/volta-af-xplorer.json"}}