VX1

JSON twin: https://www.healthaidb.com/software/vx1.json

Company Name

Volta Medical

Product URL

https://www.volta-medical.com/vx1-product

Company URL

https://www.volta-medical.com/

Categories

• clinical Care
• diagnostic Support
• medical Device
• cardiology
• ai Clinical Documentation Integrity
• clinical Decision Support
• software Development
• imaging Software
• healthcare Technology
• medical Device Software
• Clinical
• Diagnostic
• Electrophysiology
• Artificial Intelligence
• Software
• Medical Imaging
• Health Technology

Summary

VX1 is an AI-driven software developed by Volta Medical to assist electrophysiologists in real-time identification and annotation of dispersed electrograms during atrial fibrillation and atrial tachycardia procedures, aiming to enhance catheter ablation outcomes for complex arrhythmias.

Description

VX1 is an AI decision-support software designed to aid electrophysiologists in the real-time annotation of 3D anatomical and electrical maps of the human atria, specifically targeting dispersed electrograms associated with atrial fibrillation and atrial tachycardia. By identifying these abnormalities, VX1 aims to optimize catheter ablation procedures, potentially improving patient outcomes in complex arrhythmia cases. The software is compatible with most multipolar catheters and mapping technologies used in electrophysiology labs and operating rooms. It has received FDA clearance and holds a CE mark, indicating its regulatory approval for use in the United States and Europe. The company, Volta Medical, was founded in 2016 by three physicians and a data scientist in Marseille, France, with the goal of advancing cardiac arrhythmia management through AI-driven solutions.

Api Available

unknown

Certifications

• FDA 510(k)
• CE Mark
• ISO 13485
• ISO 14971
• IEC 62304
• IEC 60601-1
• IEC 60601-1-2
• IEC 60601-1-6
• IEC 60601-1-8
• IEC 60601-1-11
• IEC 60601-1-12
• IEC 60601-1-15
• IEC 60601-1-16
• IEC 60601-1-17
• IEC 60601-1-18
• IEC 60601-1-19
• IEC 60601-1-20
• IEC 60601-1-21
• IEC 60601-1-22
• IEC 60601-1-23

Company Founding

2016

Company Offices

• France
• United States
• Germany
• United Kingdom
• Italy
• Spain
• Netherlands
• Belgium
• Switzerland
• Austria

Compliance

• HIPAA
• GDPR
• FDA 510(k)
• CE Mark
• ISO 13485
• ISO 14971
• IEC 62304
• IEC 60601-1
• IEC 60601-1-2
• IEC 60601-1-6
• IEC 60601-1-8
• IEC 60601-1-11
• IEC 60601-1-12
• IEC 60601-1-15
• IEC 60601-1-16
• IEC 60601-1-17
• IEC 60601-1-18
• IEC 60601-1-19
• IEC 60601-1-20
• IEC 60601-1-21
• IEC 60601-1-22
• IEC 60601-1-23

Customers

Data Residency

EU-only

Data Standards

• DICOM
• HL7
• FHIR

Deployment Model

• SaaS
• on_prem
• hybrid

Features

• Real-time annotation of 3D anatomical and electrical maps
• Detection of dispersed electrograms indicative of arrhythmia drivers
• Compatibility with most electrophysiology recording and mapping systems
• User-friendly interface for identifying regions of interest
• Integration with multipolar catheters and mapping technologies
• AI-driven analysis using machine learning and deep learning algorithms
• Support for atrial fibrillation and atrial tachycardia procedures
• Enhanced workflow efficiency for electrophysiologists
• FDA cleared and CE marked as a Class IIa medical device
• Data-driven insights for improved patient outcomes

Id

SW0389

Integration Partners

Integrations

• Electrophysiology recording systems
• 3D navigation systems
• Mapping catheters

Languages Supported

• English
• French
• German
• Spanish
• Italian
• Dutch
• Swedish
• Danish
• Norwegian
• Finnish
• Irish
• Portuguese
• Polish
• Czech
• Slovak
• Hungarian
• Romanian
• Bulgarian
• Greek
• Turkish

Last Updated

2025-10-11

License

Commercial

Market Segment

• Enterprise
• SMB
• Consumer

Optional Modules

• Booster Mode for increased sensitivity during specific arrhythmias

Os Platforms

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

Pricing Details

Contact vendor for pricing information.

Pricing Model

Subscription

Privacy Features

• Business Associate Agreement (BAA) available
• Consent management
• Data anonymization
• Data minimization

Product Code

SW0389

Product Name

VX1

Ratings

Regions Available

• United States
• Europe
• France
• Germany
• United Kingdom
• Italy
• Spain
• Netherlands
• Belgium
• Switzerland
• Austria
• Sweden
• Denmark
• Norway
• Finland
• Ireland
• Portugal
• Poland
• Czech Republic
• Slovakia

Related Urls

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

Release Year

Security Features

• Encryption at rest and in transit
• Role-based access control (RBAC)
• Audit logs
• Two-factor authentication (2FA)
• Data loss prevention (DLP)

Specialties

• Cardiology
• Electrophysiology
• Arrhythmia Management
• Atrial Fibrillation
• Atrial Tachycardia
• Catheter Ablation
• Medical Imaging
• Artificial Intelligence In Healthcare
• Medical Device Software
• Clinical Decision Support

Support Channels

System Requirements

• Compatible electrophysiology recording systems
• Multipolar catheters
• Mapping technologies

Target Users

• Electrophysiologists
• Cardiologists
• Medical Professionals
• Healthcare Providers
• Hospital Staff
• Clinical Researchers
• Medical Device Manufacturers
• Regulatory Bodies
• Patients
• Medical Institutions

Training Options

Type

product

User Reviews

Version

1.0

Alternatives

See related products

Canonical JSON

{
  "product_name": "VX1",
  "company_name": "Volta Medical",
  "product_url": "https://www.volta-medical.com/vx1-product",
  "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": "SW0389",
  "summary": "VX1 is an AI-driven software developed by Volta Medical to assist electrophysiologists in real-time identification and annotation of dispersed electrograms during atrial fibrillation and atrial tachycardia procedures, aiming to enhance catheter ablation outcomes for complex arrhythmias.",
  "description": "VX1 is an AI decision-support software designed to aid electrophysiologists in the real-time annotation of 3D anatomical and electrical maps of the human atria, specifically targeting dispersed electrograms associated with atrial fibrillation and atrial tachycardia. By identifying these abnormalities, VX1 aims to optimize catheter ablation procedures, potentially improving patient outcomes in complex arrhythmia cases. The software is compatible with most multipolar catheters and mapping technologies used in electrophysiology labs and operating rooms. It has received FDA clearance and holds a CE mark, indicating its regulatory approval for use in the United States and Europe. The company, Volta Medical, was founded in 2016 by three physicians and a data scientist in Marseille, France, with the goal of advancing cardiac arrhythmia management through AI-driven solutions.",
  "categories": [
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    "diagnostic Support",
    "medical Device",
    "cardiology",
    "ai Clinical Documentation Integrity",
    "clinical Decision Support",
    "software Development",
    "imaging Software",
    "healthcare Technology",
    "medical Device Software",
    "Clinical",
    "Diagnostic",
    "Medical Device",
    "Cardiology",
    "Electrophysiology",
    "Artificial Intelligence",
    "Software",
    "Medical Imaging",
    "Health Technology",
    "Medical Device Software"
  ],
  "market_segment": [
    "Enterprise",
    "SMB",
    "Consumer"
  ],
  "target_users": [
    "Electrophysiologists",
    "Cardiologists",
    "Medical Professionals",
    "Healthcare Providers",
    "Hospital Staff",
    "Clinical Researchers",
    "Medical Device Manufacturers",
    "Regulatory Bodies",
    "Patients",
    "Medical Institutions"
  ],
  "specialties": [
    "Cardiology",
    "Electrophysiology",
    "Arrhythmia Management",
    "Atrial Fibrillation",
    "Atrial Tachycardia",
    "Catheter Ablation",
    "Medical Imaging",
    "Artificial Intelligence In Healthcare",
    "Medical Device Software",
    "Clinical Decision Support"
  ],
  "regions_available": [
    "United States",
    "Europe",
    "France",
    "Germany",
    "United Kingdom",
    "Italy",
    "Spain",
    "Netherlands",
    "Belgium",
    "Switzerland",
    "Austria",
    "Sweden",
    "Denmark",
    "Norway",
    "Finland",
    "Ireland",
    "Portugal",
    "Poland",
    "Czech Republic",
    "Slovakia"
  ],
  "languages_supported": [
    "English",
    "French",
    "German",
    "Spanish",
    "Italian",
    "Dutch",
    "Swedish",
    "Danish",
    "Norwegian",
    "Finnish",
    "Irish",
    "Portuguese",
    "Polish",
    "Czech",
    "Slovak",
    "Hungarian",
    "Romanian",
    "Bulgarian",
    "Greek",
    "Turkish"
  ],
  "pricing_model": "Subscription",
  "pricing_details": "Contact vendor for pricing information.",
  "license": "Commercial",
  "company_offices": [
    "France",
    "United States",
    "Germany",
    "United Kingdom",
    "Italy",
    "Spain",
    "Netherlands",
    "Belgium",
    "Switzerland",
    "Austria"
  ],
  "company_founding": "2016",
  "deployment_model": [
    "SaaS",
    "on_prem",
    "hybrid"
  ],
  "os_platforms": [
    "Web",
    "iOS",
    "Android",
    "Windows",
    "macOS",
    "Linux"
  ],
  "features": [
    "Real-time annotation of 3D anatomical and electrical maps",
    "Detection of dispersed electrograms indicative of arrhythmia drivers",
    "Compatibility with most electrophysiology recording and mapping systems",
    "User-friendly interface for identifying regions of interest",
    "Integration with multipolar catheters and mapping technologies",
    "AI-driven analysis using machine learning and deep learning algorithms",
    "Support for atrial fibrillation and atrial tachycardia procedures",
    "Enhanced workflow efficiency for electrophysiologists",
    "FDA cleared and CE marked as a Class IIa medical device",
    "Data-driven insights for improved patient outcomes"
  ],
  "optional_modules": [
    "Booster Mode for increased sensitivity during specific arrhythmias"
  ],
  "integrations": [
    "Electrophysiology recording systems",
    "3D navigation systems",
    "Mapping catheters"
  ],
  "data_standards": [
    "DICOM",
    "HL7",
    "FHIR"
  ],
  "api_available": "unknown",
  "system_requirements": [
    "Compatible electrophysiology recording systems",
    "Multipolar catheters",
    "Mapping technologies"
  ],
  "compliance": [
    "HIPAA",
    "GDPR",
    "FDA 510(k)",
    "CE Mark",
    "ISO 13485",
    "ISO 14971",
    "IEC 62304",
    "IEC 60601-1",
    "IEC 60601-1-2",
    "IEC 60601-1-6",
    "IEC 60601-1-8",
    "IEC 60601-1-11",
    "IEC 60601-1-12",
    "IEC 60601-1-15",
    "IEC 60601-1-16",
    "IEC 60601-1-17",
    "IEC 60601-1-18",
    "IEC 60601-1-19",
    "IEC 60601-1-20",
    "IEC 60601-1-21",
    "IEC 60601-1-22",
    "IEC 60601-1-23"
  ],
  "certifications": [
    "FDA 510(k)",
    "CE Mark",
    "ISO 13485",
    "ISO 14971",
    "IEC 62304",
    "IEC 60601-1",
    "IEC 60601-1-2",
    "IEC 60601-1-6",
    "IEC 60601-1-8",
    "IEC 60601-1-11",
    "IEC 60601-1-12",
    "IEC 60601-1-15",
    "IEC 60601-1-16",
    "IEC 60601-1-17",
    "IEC 60601-1-18",
    "IEC 60601-1-19",
    "IEC 60601-1-20",
    "IEC 60601-1-21",
    "IEC 60601-1-22",
    "IEC 60601-1-23"
  ],
  "security_features": [
    "Encryption at rest and in transit",
    "Role-based access control (RBAC)",
    "Audit logs",
    "Two-factor authentication (2FA)",
    "Data loss prevention (DLP)"
  ],
  "privacy_features": [
    "Business Associate Agreement (BAA) available",
    "Consent management",
    "Data anonymization",
    "Data minimization"
  ],
  "data_residency": "EU-only",
  "customers": [],
  "user_reviews": [],
  "ratings": [],
  "support_channels": [],
  "training_options": [],
  "release_year": "",
  "integration_partners": [],
  "id": "SW0389",
  "slug": "vx1",
  "type": "product",
  "version": "1.0",
  "last_updated": "2025-10-11",
  "links_json": {
    "self": "https://www.healthaidb.com/software/vx1.json"
  }
}