Biosense Webster

Irvine, CA, USA  All United States companies → Founded 1970
Healthcare Conglomerate Medical Device / Hardware Specialty-Focused AI
Cardiology
Cardiology AI Surgical AI
Acquired (by Johnson & Johnson) — N/A (Acquired by Johnson & Johnson for $400M in 1997)

Products

CARTO™ 3 EP Navigation System Software V8.0 (FG-5400-00
Biosense Webster, Inc.
Cardiology AI
The CARTO™ 3 EP Navigation System Software V8.0 by Biosense Webster is an FDA-cleared, AI-powered 3D cardiac mapping and navigation system for electrophysiologists, enhancing diagnosis and treatment of heart rhythm disorders like AFib and VT.

See all 1 product →

About Biosense Webster

Biosense Webster, Inc., a Johnson & Johnson MedTech company, stands as a global leader in the diagnosis and treatment of cardiac arrhythmias, particularly atrial fibrillation (AFib). The company is dedicated to transforming electrophysiology through innovative technologies that empower physicians to achieve optimal patient outcomes. Their comprehensive suite of tools includes advanced 3D cardiac mapping and navigation systems, such as the CARTO® 3 System, along with a range of electrophysiology catheters (diagnostic and therapeutic) and ablation technologies.

Recently, Biosense Webster has integrated artificial intelligence (AI) capabilities into its flagship CARTO® 3 System with the launch of Version 8. This advancement includes AI-cleared algorithms, such as the CARTOSOUND™ FAM module, which enables automated 3D shell creation using deep-learning technology for intracardiac ultrasound. This innovation aims to enhance efficiency, reproducibility, and accuracy for electrophysiologists performing catheter ablation procedures by providing automatic left atrial anatomy generation and improved signal analysis.

Beyond product development, Biosense Webster actively supports extensive research and clinical studies, collaborates with electrophysiologists, and provides educational programs through online courses and global education centers. Their commitment is to advance clinical understanding, improve procedural methodologies, and enhance safety for both patients and physicians in the treatment of heart rhythm disorders.

Focus Areas

Cardiac arrhythmias Atrial Fibrillation (AFib) Electrophysiology 3D Heart Mapping Catheter Ablation Diagnostic Catheters Therapeutic Catheters Ultrasound Solutions Pulsed Field Ablation (PFA) AI tools for cardiac procedures

Business Intelligence

Key InvestorsN/A (Subsidiary of Johnson & Johnson)
PartnershipsGE Healthcare, Siemens Healthcare, Stereotaxis, over 150 global research centers and investigators
AcquisitionsCoherex Medical, Inc. (2015)
TechnologyCARTO 3 System (3D heart mapping), CARTO Sound FAM (AI for left atrial anatomy generation), CARTO Elevate (AI for activation maps and arrhythmia tracking), VARIPULSE Platform (Pulsed Field Ablation - PFA), TRUPULSE Generator, TRUEref technology
FDA ClearancesMultiple, including CARTO 3 System (2009), CARTO Sound FAM (AI, 2024), and several AFib ablation products for zero fluoroscopy workflow (2023). cleared products (estimated)

What Physicians Need to Know

Cardiac Arrhythmias & Atrial Fibrillation (AFib) Treatment
Biosense Webster is a global market leader in the diagnosis and treatment of cardiac arrhythmias, with a primary goal to enable patients with AFib to live full lives. They offer a comprehensive suite of tools for electrophysiologists to personalize approaches for patients with effective and reproducible workflows. Their solutions address the most common type of cardiac arrhythmia, AFib, which affects nearly 40 million people worldwide and can lead to serious complications if left untreated.
Electrophysiology & 3D Heart Mapping
The CARTOu2122 3 System is the cornerstone of Biosense Webster's portfolio, providing advanced 3D heart mapping and navigation. This system uses electromagnetic technology to generate real-time, color-coded 3D maps of cardiac structures, guiding electrophysiologists during diagnostic and therapeutic procedures. Recent updates, such as CARTOu2122 3 System Version 8, include new modules like CARTO ELEVATEu2122 and CARTOSOUNDu2122 FAM, designed to enhance efficiency, reproducibility, and accuracy in electro-anatomical maps.
Catheter Ablation Solutions
Biosense Webster offers a wide range of diagnostic and therapeutic catheters for cardiac ablation procedures. Key therapeutic catheters include the THERMOCOOL SMARTTOUCHu2122 SF Catheter, known for its contact force technology and integration with the CARTOu2122 3 System, optimizing lesion creation. Diagnostic catheters like the OCTARAYu2122 Mapping Catheter with TRUErefu2122 Technology provide high-density, high-definition maps with improved signal quality and efficiency, potentially shortening procedure times.
Ultrasound Solutions
Their ultrasound solutions, such as the SOUNDSTARu00ae Ultrasound Catheter with the CARTOSOUNDu00ae Module, deliver real-time intracardiac echocardiography (ICE) imaging and navigation. These solutions are fully integrated with the CARTOu2122 3 System, offering visualization of target cardiac anatomy and enabling workflow efficiencies, including the potential for reduced radiation exposure.
Pulsed Field Ablation (PFA)
Biosense Webster is at the forefront of Pulsed Field Ablation (PFA) technology with its VARIPULSEu2122 Platform. This fully integrated system includes the VARIPULSEu2122 Catheter and TRUPULSEu2122 Generator, designed to deliver ablations at precise locations with tissue-selective properties, potentially maximizing safety and effectiveness. The VARIPULSEu2122 Platform's integration with the CARTOu2122 3 Mapping System allows for accurate visualization and has shown promising safety and effectiveness data in clinical trials for paroxysmal AFib.
AI Tools for Cardiac Procedures
Biosense Webster has integrated advanced AI algorithms into its CARTOu2122 3 System. The CARTOSOUNDu2122 FAM Module, cleared by the FDA, utilizes deep learning to automatically generate 3D models of the left atrial anatomy from intracardiac ultrasound, streamlining workflow and improving accuracy. The CARTO ELEVATEu2122 Module also incorporates AI to enhance signal analysis, improve substrate characterization, and track AFib burden before and after ablation.
Physician Tip

For physicians, Biosense Webster stands out due to its integrated ecosystem centered around the CARTOu2122 3 System, which offers unparalleled 3D mapping and navigation capabilities. The continuous innovation, including AI-powered modules like CARTOSOUNDu2122 FAM and CARTO ELEVATEu2122, significantly enhances procedural efficiency, accuracy, and reproducibility. The portfolio of diagnostic and therapeutic catheters, such as the OCTARAYu2122 for high-density mapping and THERMOCOOL SMARTTOUCHu2122 SF for contact force ablation, provides precise tools for diverse arrhythmia treatments. The introduction of the VARIPULSEu2122 PFA Platform, seamlessly integrated with CARTOu2122, offers a promising new modality with demonstrated safety and effectiveness, potentially reducing fluoroscopy exposure. This comprehensive approach, coupled with a strong commitment to research and education, empowers electrophysiologists to deliver personalized, safe, and effective care, ultimately improving patient outcomes and potentially reducing procedure times and radiation exposure.

Biosense Webster's core strength lies in its integrated ecosystem, with the CARTOu2122 3 System serving as the central hub for all its diagnostic, mapping, and ablation technologies. This seamless integration ensures that catheters, ultrasound solutions (e.g., SOUNDSTARu2122 with CARTOSOUNDu2122 Module, NUVISIONu2122 NAV), and advanced ablation systems (e.g., THERMOCOOL SMARTTOUCHu2122 SF, VARIPULSEu2122 PFA Platform) work cohesively. The CARTOu2122 3 System's ability to integrate with various devices and its new AI modules (CARTOSOUNDu2122 FAM, CARTO ELEVATEu2122) streamline workflows, enhance data analysis, and support advanced procedural guidance. Furthermore, the CARTONETu2122 cloud-based platform facilitates data sharing and analysis across institutions, fostering continuous learning and improvement in electrophysiology.

Products by Biosense Webster

1 product in the directory

CARTO™ 3 EP Navigation System Software V8.0 (FG-5400-00
Biosense Webster, Inc.
Cardiology AI
The CARTO™ 3 EP Navigation System Software V8.0 by Biosense Webster is an FDA-cleared, AI-powered 3D cardiac mapping and navigation system for electrophysiologists, enhancing diagnosis and treatment of heart rhythm disorders like AFib and VT.

What the Web Says

Biosense Webster is a global leader in cardiac arrhythmia treatment, part of Johnson & Johnson MedTech, and is generally recognized as a market leader in cardiac mapping and ablation. The company's products, such as the CARTO 3 System and ThermoCool irrigated ablation catheter, are highly regarded for their advanced technology in electrophysiology. As an employer, reviews are mixed, with many highlighting excellent benefits and opportunities for professional growth, while others point to issues with management and a competitive internal environment.

Overall: Mixed

Strengths

  • Incredible and cutting-edge technology in cardiac arrhythmia treatment.
  • Outstanding benefits and a pension for employees.
  • Opportunities for advancement and professional development.
  • Inclusive work environment and good company culture in some areas.
  • Products like the CARTO 3 System and ThermoCool Smarttouch Catheter offer high success rates and improved patient outcomes.
  • Commitment to ethical practices and improving patient care globally.

Limitations

  • Some employees report dictatorial bosses and strong favoritism, creating a toxic work environment.
  • High politics and constantly changing management styles.
  • Stressful work environment and competitive dynamics between team members.
  • Work-life balance can vary and travel can be stressful.
  • High turnover in some departments and inexperienced managers.
  • Compensation for entry-level clinical specialist roles may be limiting for experienced professionals.

Based on reviews from: Indeed.com, Which Medical Device, Reddit, DAIC, Zippia, FlexJobs

Last updated: 2026-07-18

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Press & Coverage

Biosense Webster (Johnson & Johnson MedTech)
Biosense Webster Receives FDA Approval for Multiple Atrial Fibrillation Ablation Products to be Used in a Workflow Without Fluoroscopy
Biosense Webster received FDA approval for several of its cardiac ablation products to be used in a zero-fluoroscopy workflow, enhancing safety and efficiency for atrial fibrillation procedures. This approval was based on real-world evidence from the REAL AF Registry.
2023-08
Becker's Hospital Review
J&J subsidiary fined $147M for limiting catheter access - Becker's Hospital Review | Healthcare News & Analysis
A California jury awarded $147 million in damages against Biosense Webster, a Johnson & Johnson subsidiary, for illegally restricting hospitals' access to clinical support when using reprocessed catheters. The lawsuit, filed by Innovative Health, alleged antitrust violations.
2025-05
Biosense Webster (Johnson & Johnson MedTech)
Biosense Webster Supports Collaborative Studies That Aim to Expand Knowledge in Pulsed Field Ablation
Biosense Webster announced its support for two collaborative studies, VIRTUE and POLARIS, to further understand the use and workflows of its investigational VARIPULSEu2122 Platform for treating various atrial arrhythmias. This follows the VARIPULSEu2122 Platform's first regulatory approval in Japan in January 2024.
2024-02
EP Lab Digest
Biosense Webster Announces Results From inspIRE and admIRE Clinical Trials
Biosense Webster presented late-breaking data from its inspIRE and admIRE clinical trials, showcasing promising results for cardiac ablation using the VARIPULSE Platform. The inspIRE study demonstrated 80% freedom from atrial arrhythmia recurrence at 12 months.
2024-02
BioWorld
Biosense Webster continues PFA approval trend, nabs CE mark for Varipulse
Johnson & Johnson's Biosense Webster unit secured CE mark for its Varipulse platform for the treatment of symptomatic, drug-refractory recurrent paroxysmal atrial fibrillation, continuing a trend of regulatory approvals for pulsed field ablation devices globally.
2024-01
Diagnostic and Interventional Cardiology
Biosense Webster Highlights New Research and Technology to Advance AFib Treatment at Heart Rhythm 2023
Biosense Webster presented data from 28 company-sponsored and funded studies at Heart Rhythm 2023, covering radiofrequency and pulsed field ablation, digital technologies, and real-world evidence for cardiac arrhythmia treatment.
2023-05
PubMed Central (PMC)
The feasibility of utilising a cloud-based storage and analysis software in multicentre clinical electrophysiology research - PMC
A study funded by a Biosense Webster Investigator Initiated Study (IIS) Grant explored the feasibility of using cloud-based storage and analysis software for multicenter clinical electrophysiology research, particularly for 3D mapping cases within the CARTO-3 system.
2023-05
BioWorld
Biosense Webster launches Optrell catheter to map complex cardiac arrhythmias
Biosense Webster launched the high-density diagnostic Optrell mapping catheter with Trueref technology, powered by its Carto 3 software, in the U.S. on July 24, designed to map complex cardiac arrhythmias more accurately.
2024-07

Frequently Asked Questions

Biosense Webster's VARIPULSEu2122 Platform represents their PFA advancement, integrating the VARIPULSEu2122 Catheter and TRUPULSEu2122 Generator with the CARTOu2122 3 System for a streamlined workflow in AFib treatment. For AI integration, the latest CARTOu2122 3 platform incorporates machine learning algorithms, such as the Cartosound FAM software module and Elevate module, to automate 3D heart anatomy modeling and enhance arrhythmia tracking during procedures.
Biosense Webster's CARTOu2122 3 System provides real-time, high-resolution 3D maps of the heart's electrical activity, enabling precise catheter navigation and lesion placement. This technology, including modules like CARTO Prime, enhances mapping capabilities, helps reduce ablation times, and supports zero-fluoroscopy workflows, ultimately improving procedural efficiency and patient safety.
Biosense Webster offers a broad range of diagnostic catheters, including CRISTACATHu2122 Catheters, DECANAVu00ae Catheter, HALOu2122 XP Tricuspid Mapping Catheter, and the OCTARAYu2122 high-density mapping catheter for detailed electrophysiological mapping. Their therapeutic catheter portfolio includes the NAVISTARu2122 Catheter, CARTOu00ae THERMOCOOLu2122 Bi-Directional Catheter for radiofrequency ablation, and the VARIPULSEu2122 Catheter for pulsed field ablation.
As part of Johnson & Johnson MedTech, Biosense Webster adheres to stringent regulatory requirements, including FDA's Quality Management System Regulation (21 CFR Part 820), Unique Device Identification (UDI) Rule, and medical device reporting. The company states a commitment to enhancing safety for both patients and physicians through its innovations. However, it's important to note a recent legal finding where Biosense Webster was found to have illegally restricted clinical support for hospitals using reprocessed catheters from third parties.
Biosense Webster provides comprehensive clinical support for procedures utilizing their CARTOu2122 3 Navigation System, alongside customer training plans to ensure effective product use. They also offer technical service, system upgrades, and software-as-a-service solutions to optimize program efficiency. Dedicated clinical and technical support centers are available for assistance.
Biosense Webster's advanced EP solutions, such as the CARTOu2122 3 System, aim to improve procedural efficiency and reduce ablation times, which can lead to lower per-procedure overhead costs for healthcare facilities. Technologies like FAM-DX can also reduce the need for expensive upfront ablation catheters. The overall value proposition focuses on improving patient outcomes, enhancing procedural methodologies, and increasing success rates, translating into both clinical and economic benefits.
As a global leader in cardiac arrhythmia treatment and part of Johnson & Johnson MedTech, Biosense Webster's strategic vision is centered on continuous innovation, advancing scientific understanding, and improving AFib education. They are actively investing in new technologies like PFA and AI, conducting extensive research, and fostering external research partnerships to maintain leadership and deliver innovative solutions for electrophysiologists and patients worldwide.

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