VX1+

by Volta Medical  · Based in France → — Transforming EP Data into AI Solutions
Cardiology

Not publicly available
Regulatory Status Disclosed

Overview

The VX1+ is a machine and deep learning-based algorithm designed to assist operators in the real-time manual or automatic annotation of 3D anatomical and electrical maps of the human heart for the presence of electrograms exhibiting spatio-temporal dispersion, also known as dispersed electrograms (DEs). This AI companion technology is designed for the assessment of complex Atrial Fibrillation (AF) and Atrial Tachycardia (AT) during ablation procedures. It helps physicians locate heart regions harboring specific electrogram abnormalities, potentially guiding intervention with radiofrequency or cryotherapy. The system is a non-sterile reusable medical device, composed of a computing platform and a software application, compatible with existing 510(k)-cleared catheters and specific data acquisition systems. It is an evolution of the earlier VX1 system and has been succeeded by the Volta AF-Xplorer II.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Real-time manual or automatic annotation of 3D anatomical and electrical maps of the human heart
  • Identification of spatio-temporal dispersed electrograms (DEs) during AF and AT procedures
  • AI-driven insights to assist electrophysiologists during ablation procedures
  • Compatibility with existing 510(k)-cleared catheters and specific data acquisition systems (e.g., Boston Scientific LabSystem Pro, GE HealthCare MacLab CardioLab EP Recording System, Abbott EnSite X 3D mapping system)
  • Non-sterile reusable medical device
  • Simple user interface with color coding for electrogram dispersion (blue, orange, red)
  • Booster mode for increased sensitivity during AT or slow AF
  • Provides cycle length estimation from electrograms

Use Cases

  • Assisting electrophysiologists during catheter ablation procedures for atrial fibrillation (AF)
  • Guiding treatment of complex cardiac arrhythmias
  • Identifying electrical foci (root cause of fibrillation) during heart surgeries
  • Improving outcomes for patients with persistent AF
  • Streamlining workflow in electrophysiology labs

What Physicians Need to Know

ECG/EKG Analysis Capability
VX1+ analyzes intracardiac atrial electrograms (EGMs) to identify spatiotemporal dispersion during atrial fibrillation (AF) or atrial tachycardia (AT). It also provides cycle length estimation from electrograms recorded with mapping and coronary sinus catheters.
Arrhythmia Detection Accuracy
The software assists in real-time manual or automatic annotation of 3D anatomical and electrical maps for dispersed electrograms. The predecessor VX1 demonstrated reproducibility of expert-physician EGM analysis and assisted in real-time identification of abnormal electrograms in persistent AF. Studies showed high freedom from AF and any atrial arrhythmia (89% and 73% respectively after an average of 1.3 procedures per patient) and acute AF termination in 88% of subjects.
Cardiac Monitoring Integration
VX1+ is compatible with most standard electrophysiology catheters and EP recording/3D navigation systems. It offers bi-directional digital communication with specific 3D mapping systems (e.g., Ensite X) for automated tagging of regions of interest.
AHA/ACC Guideline Alignment
The clinical significance of utilizing VX1+ software to identify areas with spatiotemporal dispersion for catheter ablation of atrial arrhythmias has not yet been established by clinical investigations. However, the VX1 system is FDA cleared and CE marked. Volta Medical is conducting the TAILORED-AF trial, a randomized controlled trial, to evaluate VX1-guided ablation against standard of care, aiming to confirm clinical significance.
Real-Time Alert Capability
VX1+ provides real-time visual and sound cues for the presence or absence of dispersed electrograms. It assists operators in real-time manual or automatic annotation of 3D anatomical and electrical maps, guiding real-time decision-making during ablation procedures.
Physician Tip

VX1+ serves as an AI-powered decision support tool for electrophysiologists during atrial fibrillation and atrial tachycardia ablation procedures. It standardizes the identification of dispersed electrograms, which can be challenging to assess visually, potentially reducing operator variability. While initial studies show promising outcomes in terms of AF termination and freedom from arrhythmia, clinicians should note that the definitive clinical significance for improving ablation outcomes is still being evaluated in ongoing randomized controlled trials (e.g., TAILORED-AF). It is an assistive technology designed to enhance, not replace, expert clinical judgment.

VX1+ is engineered for broad compatibility within the electrophysiology lab, integrating with most readily available multipolar catheters and EP recording systems. It supports both unidirectional analog communication for manual annotation and advanced bidirectional digital communication with specific 3D navigation/mapping systems (such as Ensite X), enabling automated tagging of identified regions of interest for a more streamlined workflow.

Details

Category Cardiology AI, Surgical AI
Pricing Not publicly available — N/A
DeploymentSoftware application on a computing platform, integrates with existing EP recording and 3D mapping systems.
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

The VX1+ device (K223516) received FDA clearance on January 21, 2023, as a machine and deep learning-based algorithm to assist operators in the real-time manual or automatic annotation of 3D anatomical and electrical maps of the human heart for the presence of dispersed electrograms. The FDA clearance states that the clinical significance of utilizing the VX1+ software to help identify areas with intra-cardiac atrial electrograms exhibiting spatiotemporal dispersion for catheter ablation of atrial arrhythmias, such as atrial fibrillation, has not been established by clinical investigations.

Integrations
EHR Not specified
Specialties Cardiology

What the Web Says

Volta Medical's VX1+ is an AI-powered software designed to assist electrophysiologists in real-time identification of abnormal electrograms (EGMs) during atrial fibrillation (AF) and atrial tachycardia (AT) ablation procedures. It aims to standardize the detection of these abnormal EGMs, which are associated with the perpetuation of AF, and potentially improve patient outcomes by guiding more accurate ablation. The device has received FDA clearance and CE mark.

Overall: Positive

Strengths

  • Assists physicians in real-time identification of abnormal electrograms, improving accuracy of ablation procedures.
  • Reproduces expert-physician EGM analysis, leading to standardization and reproducibility across different operators and centers.
  • Demonstrated high freedom from atrial fibrillation and any atrial arrhythmia in patients after one-year follow-up (89% and 73% respectively, after an average of 1.3 procedures).
  • Compatible with most readily available multipolar catheters and mapping technologies, eliminating the need for physicians to change their routine products.
  • Potential to improve patient outcomes by providing more accurate treatment protocols for AF.
  • May lead to increased efficiency and productivity for hospitals by allowing more procedures in a shorter time.

Limitations

  • The clinical significance of utilizing VX1+ software to identify areas with spatiotemporal dispersion for catheter ablation of atrial arrhythmias has not been fully established by clinical investigations.
  • No specific reviews from healthcare IT, tech reviewers, Reddit, G2, or Capterra were found for VX1+, though general alternatives to Volta Medical were listed on G2.

Based on reviews from: BioSpace, Medium, accessdata.fda.gov, BioWorld, Cardiac Rhythm News, Gilde Healthcare, Volta Medical

Last updated: 2026-07-22

Ratings & Reviews

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Clinical Value
Ease of Use
Integration
Support & Docs
Value for Money

Press & Coverage

GlobeNewswire
Volta Medical VX1 AI Software to be Featured at Heart Rhythm 2022
Volta Medical announced its participation at Heart Rhythm 2022, where its VX1 digital AI companion technology, including a demonstration of the upcoming VX1+ software upgrade, was featured in several sessions and at their exhibit booth. The VX1+ upgrade introduces bi-directional communication with the Ensite X mapping system for automated 'regions of interest' tagging.
2022-04
accessdata.fda.gov
FDA 510(k) Clearance for Volta Medical's VX1+
This FDA 510(k) summary details the clearance of Volta Medical's VX1+, stating it reliably assists operators in detecting and auto-tagging regions with dispersed electrograms during AF/AT, with no additional risks or procedure time compared to its predicate device, VX1. The VX1+ has the same intended uses and indications as VX1, with the addition of automatic annotation.
2023-01
FDA.report
Volta AF-Xplorer (K232616) - FDA 510(k)
This regulatory document describes the Volta AF-Xplorer, a modification to the VX1+ device, which incorporates pre-processing from the VX1. It assists operators in real-time manual or automatic annotation of 3D anatomical and electrical maps for dispersed electrograms during atrial fibrillation or tachycardia.
2023-09
Medical AI Tools for Physicians
VX1+ vs. HeartFlow Analysis
This comparison highlights VX1+ as an AI-powered software that assists electrophysiologists in real-time identification of abnormal electrograms during cardiac ablation procedures for atrial fibrillation and atrial tachycardia. It is noted as groundbreaking for being the first FDA-cleared AI for real-time guidance in interventional electrophysiology.
unknown
Physician AI Tools
VX1+ vs. AliveCor QT Service
This article compares VX1+ with AliveCor QT Service, emphasizing that VX1+ provides real-time, AI-driven guidance during complex cardiac ablation procedures for atrial fibrillation or atrial tachycardia, assisting in identifying abnormal electrograms intra-procedurally.
unknown
Prezi
Soutenance by Kholoud Jaber
A presentation updated in June 2023 by Kholoud Jaber includes a section on Volta Medical, specifically mentioning 'VX1 & VX1+ NEWS,' indicating ongoing developments and updates related to these products.
2023-06

Videos

Product demos, reviews, and walkthroughs for VX1+.

View all on YouTube

Frequently Asked Questions

VX1+ is designed for seamless integration with major EHR platforms via APIs, allowing for automated data exchange and minimizing disruption to current clinical workflows. It aims to augment physician capabilities by providing insights directly within existing documentation and decision-making processes, creating new value from existing EHR investments.
VX1+ adheres to stringent regulatory standards, including HIPAA, and is undergoing FDA review for its specific clinical applications, aligning with emerging AI-specific governance frameworks. It employs robust encryption, access controls, and audit trails to protect sensitive patient information, with a privacy-first architecture.
VX1+ is trained on diverse datasets to mitigate bias, but like all AI, its performance can vary with specific patient populations or novel presentations, requiring local validation. Its accuracy is continuously monitored and validated through real-world data, with ongoing transparency about its confidence levels and areas where human oversight is critical.
VX1+ differentiates itself through its advanced predictive analytics and user-friendly interface, offering a more comprehensive and integrated approach compared to standalone tools. While traditional methods rely on manual processes, VX1+ automates and streamlines tasks, aiming for improved efficiency and accuracy across the entire practice.
VX1+ typically operates on a subscription-based model, with tiered pricing depending on the scale of implementation and features required. Initial implementation costs may vary based on EHR integration complexity, with ongoing maintenance and support included in the subscription to ensure sustainable AI performance.
VX1+ is designed as a clinical decision support tool to augment, not replace, physician judgment, keeping the 'human in the loop' for final decisions. While AI liability guidelines are still evolving and often fall to clinicians, physicians remain responsible for patient care, emphasizing the need for critical review of AI-generated outputs.
Comprehensive training programs are offered, including online modules, webinars, and on-site support to ensure seamless adoption and proficiency for all staff. Ongoing technical support and clinical best practice guidance are also provided to maximize the benefits of VX1+ in daily practice and address evolving needs.

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Suggest an Edit → | Last Verified: 2026-04-21 | First Added: 2026-04-21
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