Volta AF-Xplorer

JSON twin: https://www.healthaidb.com/software/volta-af-xplorer.json

Company Name

Volta Medical

Product URL

https://www.volta-medical.com

Company URL

https://www.volta-medical.com

Categories

• clinical Care
• diagnostic Support
• patient Facing
• Clinical
• Diagnostic

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.

Api Available

unknown

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

Company Founding

2018

Company Offices

• France
• United States

Compliance

• HIPAA
• GDPR
• HITECH
• SOC 2
• ISO 27001

Customers

Data Residency

US/EU regions

Data Standards

• FHIR
• HL7 v2
• DICOM
• SNOMED
• ICD-10

Deployment Model

• SaaS
• on_prem
• hybrid

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

Id

SW0028

Integration Partners

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

Languages Supported

• English
• French
• German

Last Updated

2025-10-11

License

commercial

Market Segment

• enterprise

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

Os Platforms

• Web
• iOS
• Android
• Windows
• macOS
• Linux

Pricing Details

Contact vendor for pricing information.

Pricing Model

enterprise_quote

Privacy Features

• BAA available
• Consent management
• Anonymization
• Data minimization

Product Code

SW0028

Product Name

Volta AF-Xplorer

Ratings

Regions Available

• United States
• Europe

Related Urls

• https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices

Release Year

Security Features

• Encryption
• RBAC
• SSO/SAML
• Audit logs
• 2FA
• DLP

Specialties

• Cardiology
• Electrophysiology

Support Channels

System Requirements

Compatible with existing electrophysiology recording systems, 3D mapping/navigation systems, and mapping catheters

Target Users

• electrophysiologists
• cardiologists
• medical device technicians

Training Options

Type

product

User Reviews

Version

1.0

Alternatives

See related products

Canonical JSON

{
  "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",
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  "market_segment": [
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  "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"
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  "company_founding": "2018",
  "deployment_model": [
    "SaaS",
    "on_prem",
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  "os_platforms": [
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    "Android",
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    "macOS",
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  "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"
  }
}