CARTO™ 3 EP Navigation System Software V8.0 (FG-5400-00

by Biosense Webster, Inc.  · Based in United States → — Efficiency at Heart. Excellence at Hand.
Cardiology
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Regulatory Status Disclosed

Overview

The CARTO™ 3 EP Navigation System Software V8.0 is an advanced 3D imaging and mapping technology designed for electrophysiologists to diagnose and treat cardiac arrhythmias. As part of the comprehensive CARTO™ 3 System, this software version significantly enhances mapping capabilities through advanced tools, improved signal analysis, and utilization of ultrasound technology. It creates real-time, high-resolution 3D anatomical and electroanatomical maps of the human heart, guiding physicians during catheter ablation procedures for conditions like atrial fibrillation (AFib) and ventricular tachycardia (VT). The system integrates various modules, including AI-powered features for automated anatomy creation and enhanced signal characterization, aiming to improve efficiency, reproducibility, and accuracy in the electrophysiology lab.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Advanced Catheter Location (ACL) technology for accurate catheter visualization
  • Fast Anatomical Mapping (FAM) for rapid, high-resolution 3D cardiac maps
  • Connection of Choice for streamlined workflow and automatic catheter recognition
  • CARTO ELEVATEu2122 Module with machine learning for enhanced signal analysis and substrate characterization
  • CARTOSOUNDu2122 FAM Module utilizing AI/deep-learning for automated 3D left atrial anatomy creation
  • Enhanced CONFIDENSEu2122 Module for optimized map creation and data validation
  • LAT Velocity Vectors for visualizing activation wave velocity over substrate maps
  • Stability+ algorithm for continuous analysis of ablation catheter movement
  • Multi-Electrode Mapping (MEM) for simultaneous acquisition of multiple mapping points
  • Integration with ultrasound technology for real-time soft tissue visualization

Use Cases

  • Diagnosis and treatment of complex cardiac arrhythmias
  • Catheter ablation procedures for atrial fibrillation (AFib)
  • Catheter ablation procedures for ventricular tachycardia (VT)
  • Real-time 3D heart mapping and navigation during electrophysiological procedures
  • Substrate characterization and signal analysis for arrhythmogenic regions
  • Remote review, analysis, and sharing of CARTOu00ae 3 System cases via CARTONETu2122

What Physicians Need to Know

ECG/EKG Analysis Capability
The CARTOu2122 3 System V8.0 supports comprehensive ECG and intracardiac electrogram (IC EGM) analysis, including signal acquisition, filtering, display, and recording for up to 80 channels. The CARTO ELEVATEu2122 Module enhances signal quality by providing localized unipolar signals and facilitating complex signal identification, improving activation mapping.
Echocardiography AI Features
The CARTOSOUNDu2122 FAM Module, a new feature in V8.0, utilizes an FDA-cleared artificial intelligence (AI) algorithm (deep learning) to automatically generate highly accurate 3D left atrial anatomy from intracardiac ultrasound, significantly reducing manual contouring time. The CARTOSOUNDu2122 Module also integrates 3D ultrasound technology for real-time soft tissue visualization and monitoring of catheter tip-to-tissue contact.
Cardiac CT/MRI Analysis
The CARTOMERGEu2122 Module allows for the import of segmented CT or MRI image studies, integrating them into the CARTOu2122 3 System for comprehensive anatomical reference during procedures.
Arrhythmia Detection Accuracy
The system is designed to enhance the accuracy and reproducibility of electro-anatomical maps for diagnosing and treating various cardiac arrhythmias, including atrial fibrillation (AFib) and ventricular tachycardia. The CARTO ELEVATEu2122 Module improves signal quality and localized annotation, aiding in the identification of critical areas of interest. The Enhanced CONFIDENSEu2122 Module provides automated optimized maps, and the CARTOu2122 CFAE Module automatically detects complex fractionated atrial electrogram signals. The CARTOu2122 Late Annotation Mapping (LAM) Module aims to improve mapping annotation accuracy for low-voltage amplitude signals and local abnormal ventricular activities (LAVAs). Pattern acquisition automatically monitors arrhythmia burden.
Cardiac Monitoring Integration
The CARTOu2122 3 System V8.0 is an integrated platform that receives and processes body surface ECG and intracardiac electrogram signals. It is designed to work seamlessly with various Biosense Webster catheters, such as the OPTRELLu2122 Mapping Catheter, and the nGENu2122 Generator for ablation procedures. The CARTOCONNECTu2122 Device facilitates the export of images and videos (maps, EKGs, propagation) to a mobile app for convenient viewing and sharing.
Real-Time Alert Capability
The Stability+ algorithm continuously analyzes catheter movement, differentiating between respiratory motion and actual catheter movement, which contributes to a quicker indication of catheter stability. The system provides real-time 3D visualization and mapping to guide electrophysiologists during procedures.
Physician Tip

Leverage the new AI-powered CARTOSOUNDu2122 FAM Module for rapid and accurate left atrial anatomy reconstruction, significantly streamlining workflow by reducing the need for manual contouring. Utilize the CARTO ELEVATEu2122 Module's enhanced signal analysis and multipolar mapping with the OPTRELLu2122 Catheter to achieve more precise activation maps and better characterize complex signals, especially in challenging arrhythmia cases. Integrate CT/MRI images via CARTOMERGEu2122 for a comprehensive anatomical overview. Pay close attention to the Stability+ algorithm for real-time catheter stability feedback, which can improve procedural efficiency and safety. The automated pattern acquisition and Enhanced CONFIDENSEu2122 Module can further optimize mapping and aid in identifying critical ablation targets. The CARTOCONNECTu2122 Device offers a convenient way to share procedural data and insights with colleagues and for patient education.

The CARTOu2122 3 EP Navigation System Software V8.0 is designed for seamless integration with Biosense Webster's ecosystem of catheters, including the OPTRELLu2122 Mapping Catheter, and ablation generators like the nGENu2122 Generator. It also supports the import of segmented CT and MRI images via the CARTOMERGEu2122 Module. The CARTOCONNECTu2122 Device provides a dedicated solution for exporting and sharing system-generated media (maps, EKGs, videos) to a mobile application, enhancing communication and data accessibility within the clinical environment. The system's ECG subsystem is compatible with external recording systems for signal output.

Details

Category Cardiology AI, Surgical AI
Pricing Contact for pricing
  • Pricing for the complete CARTO™ 3 EP Navigation System Software V8.0 is not publicly available and typically requires direct consultation with Biosense Webster sales representatives
DeploymentOn-premise (EP lab system) with optional cloud-based data storage (CARTONET™)
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

The CARTO™ 3 EP Navigation System Software V8.0 (K231207) received FDA clearance on September 7, 2023, as a Class II programmable diagnostic computer (21 CFR 870.1425) for catheter-based atrial and ventricular mapping.
Integrations
EHR Not specified
Specialties Cardiology

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Press & Coverage

FDA
K231207 - 510(k) Premarket Notification
This FDA 510(k) Premarket Notification indicates that the CARTOu2122 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U) from Biosense Webster, Inc. was found substantially equivalent on September 7, 2023, after being received on April 27, 2023.
2023-09
Smarteeva
CARTOu2122 3 EP Navigation System Software V8.0 (FG-5400-00 vs Tempus ECG-Low EF
This comparison highlights the CARTOu2122 3 EP Navigation System Software V8.0 as an advanced, AI-powered 3D mapping and navigation system for complex cardiac ablation procedures, emphasizing its role in enhancing precision and efficiency for treating heart rhythm disorders.
2026-07

Videos

Product demos, reviews, and walkthroughs for CARTO™ 3 EP Navigation System Software V8.0 (FG-5400-00.

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Frequently Asked Questions

CARTOu2122 3 System Version 8 introduces machine learning capabilities, notably through the optional CARTOSOUNDu2122 FAM module. This module utilizes an FDA-cleared artificial intelligence algorithm based on deep learning to automatically generate a 3D left atrial anatomy, streamlining the process and improving efficiency by eliminating manual contouring. Additionally, the CARTO ELEVATEu2122 Module incorporates machine learning for enhanced signal analysis and improved substrate characterization.
The CARTOu2122 3 EP Navigation System Software V8.0 has received FDA clearance. Specifically, the CARTOSOUNDu2122 FAM module, which incorporates an AI algorithm, has been cleared by the FDA for use in intracardiac ultrasound. While specific details on V8.0's AI data handling in relation to HIPAA and GDPR are not explicitly detailed in the provided search results, CARTO as a company generally adheres to HIPAA for Protected Health Information in the US and GDPR for personal data of EU residents, involving practices like de-identification and encryption.
CARTOu2122 3 V8.0's AI features, such as the CARTOSOUNDu2122 FAM module, aim to enhance efficiency and accuracy in creating 3D anatomical maps by automating left atrial anatomy generation. When compared to systems like Rhythmia HDx and EnSite X, CARTO 3 is noted for its mapping speed, resolution, and automation capabilities. Studies comparing CARTO and Rhythmia in AF ablation have shown Rhythmia to have faster high-resolution mapping, though both systems demonstrated comparable acute procedural success and midterm clinical outcomes.
Specific pricing for the CARTOu2122 3 EP Navigation System Software V8.0, including initial purchase, software licenses, or AI-specific module fees, is not publicly disclosed in the provided information. CARTO (the spatial analytics platform) typically offers custom pricing based on usage, users, and deployment options, often through subscription models. Physicians interested in detailed cost information for the CARTOu2122 3 System V8.0 and its optional modules should contact a Biosense Webster sales representative.
While specific limitations or biases of CARTOu2122 3 V8.0's AI components are not detailed in the provided results, medical AI systems generally face challenges such as inheriting biases from training data, which can lead to performance disparities across diverse patient groups. To mitigate these, best practices involve using large and diverse datasets for training, continuous monitoring, and thorough model evaluation. Physicians are advised to maintain clinical judgment and be aware of the general limitations inherent in AI technologies.
Biosense Webster, as part of Johnson & Johnson MedTech, is committed to patient data security and privacy. While specific technical details for CARTOu2122 3 V8.0's AI data processing are not provided, the company's broader practices for its CARTO platform include compliance with regulations like HIPAA and GDPR. This typically involves de-identification of protected health information, encryption, access controls, and adherence to strict data processing principles to safeguard sensitive patient data.
The CARTOu2122 3 System Version 8 and its modules, including the AI-driven CARTOSOUNDu2122 FAM, come with 'Instructions for Use' documents. Biosense Webster, as the manufacturer, is expected to provide comprehensive training and ongoing support to physicians to ensure the effective and safe utilization of the system's advanced features, including its AI components. This support is crucial for integrating new technologies into clinical workflows and maximizing their benefits.

Compare CARTO™ 3 EP Navigation System Software V8.0 (FG-5400-00

VS
CARTO™ 3 EP Navigation System Software V8.0 (FG-5400-00 vs PMcardio
Cardiology AI Adjacent · 65/100
PMcardio is an AI platform focused on interpreting 12-lead ECGs to diagnose over 50 cardiac conditions, making it a diagnostic tool for various healthcare professionals at the point…
VS
CARTO™ 3 EP Navigation System Software V8.0 (FG-5400-00 vs EchoNext
Cardiology AI Adjacent · 65/100
Tool A (CARTO™ 3 EP Navigation System Software V8.0) is designed for electrophysiologists, providing advanced 3D cardiac mapping and navigation during interventional procedures for heart rhythm disorders. Tool…
VS
CARTO™ 3 EP Navigation System Software V8.0 (FG-5400-00 vs KardiaPro
Cardiology AI Adjacent · 65/100
Tool A (CARTO™ 3 EP Navigation System Software V8.0) is a specialized on-premise system for electrophysiologists, focusing on 3D cardiac mapping and navigation during invasive procedures. Tool B…
VS
SENSICARDIAC MOBI DIAGNOSTIC HEART MURMUR APPLICATION vs CARTO™ 3 EP Navigation System Software V8.0 (FG-5400-00
Cardiology AI Adjacent · 65/100
These tools are adjacent rather than direct competitors, as they address different aspects of cardiac care. SensiCardiac Mobi focuses on non-invasive acoustic analysis to aid in the diagnosis…

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Suggest an Edit → | Last Verified: 2026-04-18 | First Added: 2026-04-18
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