Products

FFRangio System
CathWorks
Cardiology AI
The CathWorks FFRangio System delivers wire-free and drug-free 3D FFR guidance, providing accurate multi-vessel FFR results and advanced insights to quickly optimize and confirm PCI decisions for patients with coronary artery disease.
FFRangio
CathWorks
Cardiology AI
FFRangio by CathWorks is an AI-powered, non-invasive system that uses routine angiograms to provide comprehensive physiological assessment of coronary artery disease, eliminating the need for invasive pressure wires and optimizing PCI decisions.

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About CathWorks

CathWorks is a medical technology company dedicated to transforming the diagnosis and treatment of coronary artery disease (CAD) by providing physicians with advanced computational science tools. Their flagship product, the FFRangio System, leverages artificial intelligence (AI) and sophisticated computational fluid dynamics to generate objective, wire-free physiological information directly from routine angiograms. This innovative approach aims to elevate coronary angiography from a visual assessment to a precise, FFR-based decision-making tool.

The FFRangio System processes standard angiogram images to create comprehensive physiological data, including color-coded 3D renderings of blood flow within the coronary arteries. This enables interventional cardiologists to optimize treatment decisions, such as determining the necessity of a stent, without the need for invasive pressure wires or pharmacologic stimulation. The system provides real-time fractional flow reserve (FFR) values across the entire coronary tree, simulated pullback curves to identify functional patterns of CAD, and integrated sizing tools for non-invasive lesion measurements.

By eliminating the invasive aspects of traditional FFR measurements, CathWorks’ technology offers a quicker, more comfortable, and comprehensive assessment for patients, while streamlining workflow in the cath lab. Clinical evidence has demonstrated its high diagnostic accuracy and promising clinical outcomes when compared to conventional wire-based FFR.

Focus Areas

Coronary Artery Disease Fractional Flow Reserve (FFR) Angiography-Derived Physiology (ADP) Artificial Intelligence Computational Hemodynamics Interventional Cardiology Medical Imaging Digital Health

Business Intelligence

Key InvestorsMedtronic, Deerfield Management, Abiomed, Innovation Authority, Ministry of Economy and Industry, Pura Vida Investments, Triventures, Corundum Open Innovation, Pontifax, BioStar Ventures, Quark Venture, Planven
PartnershipsMedtronic (co-promotion and acquisition), AdventHealth, Hackensack Meridian Mountainside Medical Center, Lenox Hill Hospital, T.J. Samson Hospital
AcquisitionsAcquired by Medtronic (pending FTC clearance, announced February 2026)
TechnologyAI and advanced computational science, angiography-derived FFR computation, computational hemodynamic simulation, 3D reconstruction and visualization of coronary arteries, computer vision for angiographic image analysis, medical device software platforms
FDA Clearances1 cleared products (estimated)

What Physicians Need to Know

Coronary Artery Disease (CAD) Assessment
CathWorks transforms CAD diagnosis and treatment by providing objective, wire-free physiological information from routine angiograms. Their FFRangiou00ae System offers a comprehensive assessment of the entire coronary tree, aiding in precise treatment decisions.
Fractional Flow Reserve (FFR) & Angiography-Derived Physiology (ADP)
Specializes in angiography-derived physiology (ADP) with its FFRangio System, which calculates FFR values from routine angiograms, eliminating the need for invasive pressure wires and drug stimulation. It provides multivessel FFR values across the entire coronary tree, including side branches.
Artificial Intelligence (AI) & Computational Hemodynamics
Leverages advanced AI algorithms and computational science to quickly analyze angiograms, create accurate 3D volumetric models of the coronary tree, and calculate resistance to blood flow along each segment. This resistance-based computational approach provides real-time FFRangio values.
Interventional Cardiology & Medical Imaging
The FFRangio System seamlessly integrates into the cath lab workflow, transforming 2D angiograms into a detailed 3D model for comprehensive physiological assessment. It offers PCI planning tools like simulated pullback curves and a Lesion Impact feature to differentiate functional patterns of CAD and assess residual ischemia.
Digital Health Innovations
CathWorks is recognized as a leader in digital health, providing innovative solutions that improve patient care globally by transforming how cardiovascular disease is diagnosed and treated through its FFRangio System.
Physician Tip

For physicians, CathWorks' FFRangio System offers a less invasive, wire-free, and drug-free approach to FFR assessment, significantly streamlining procedural workflow in the cath lab. The system provides real-time, comprehensive, multi-vessel FFR values and advanced PCI planning tools (simulated pullback, lesion impact, integrated sizing) to optimize clinical decision-making with scientific certainty, moving beyond visual estimation. This leads to reduced procedure time, radiation exposure, and contrast use, enhancing both patient comfort and safety. Clinical trials have demonstrated high diagnostic accuracy and comparable one-year major adverse cardiac event (MACE) rates to invasive FFR, reinforcing its value for evidence-based treatment.

The CathWorks FFRangio System is designed for seamless integration with existing cath lab infrastructure, including the boom and PACS (Picture Archiving and Communication System). It analyzes routine DICOM angiography data, ensuring compatibility with standard medical imaging workflows. This integration minimizes disruption and allows for efficient, parallel processing of physiological assessments during ongoing procedures.

Products by CathWorks

2 products in the directory

FFRangio System
CathWorks
Cardiology AI
The CathWorks FFRangio System delivers wire-free and drug-free 3D FFR guidance, providing accurate multi-vessel FFR results and advanced insights to quickly optimize and confirm PCI decisions for patients with coronary artery disease.
FFRangio
CathWorks
Cardiology AI
FFRangio by CathWorks is an AI-powered, non-invasive system that uses routine angiograms to provide comprehensive physiological assessment of coronary artery disease, eliminating the need for invasive pressure wires and optimizing PCI decisions.

What the Web Says

CathWorks is a company focused on optimizing care for patients with coronary artery disease through its FFRangio System. The system uses AI and advanced computational science to provide non-invasive, wire-free 3D FFR guidance from routine angiograms, aiming to improve treatment decisions and streamline workflow. While product reviews are largely positive, highlighting its diagnostic accuracy and clinical outcomes, employee reviews on platforms like Indeed suggest mixed sentiments regarding company culture, management, and work-life balance.

Overall: Mixed

Strengths

  • High diagnostic accuracy (consistently 92-97%) compared to wire-based FFR.
  • Non-invasive, eliminating the need for pressure wires, hyperemic agents, and guide catheters.
  • Provides comprehensive multi-vessel coronary physiology and PCI planning tools.
  • Reduces radiation exposure by approximately 20% compared to wire-based physiology.
  • Streamlines procedural workflow with an intuitive user interface and AI-aided analysis.
  • Comparable one-year major adverse cardiac event (MACE) rates to invasive FFR.

Limitations

  • Mixed employee reviews regarding work-life balance, pay, and benefits.
  • Negative feedback on management and job security/advancement from employees.
  • Some employee reviews mention unfair pay and inexperienced staff.
  • Diagnostic performance not established for lesions immediately after PCI.
  • The use of FFRangio may not be appropriate for all patients, particularly those with STEMI, impaired ejection fraction, severe diffuse disease, dilated coronary vessels, moderate or severe aortic stenosis, or a history of selected prior heart surgeries.
  • Limited advancement opportunities cited by some employees.

Based on reviews from: Indeed.com, PR Newswire, YouTube, Medtronic, accessdata.fda.gov, Medical Device and Diagnostic industry, Reddit

Last updated: 2026-07-17

Videos

News, demos, and interviews about CathWorks.

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Press & Coverage

Medtronic
Medtronic completes acquisition of CathWorks, expanding its leadership in transforming care for patients with cardiovascular disease
Medtronic completed its acquisition of CathWorks for $585 million, aiming to enhance its interventional cardiology portfolio with CathWorks' FFRangio System. This acquisition follows a 2022 strategic partnership and co-promotion agreement.
2026-04
PR Newswire
Landmark ALL-RISEu00ae Trial Results Presented at ACC.26: CathWorks FFRangio Demonstrates Similar Clinical Outcomes to Invasive Wire-based Physiology Assessment
The ALL-RISE trial results, presented at ACC.26 and published in the New England Journal of Medicine, showed that CathWorks FFRangio was non-inferior to invasive pressure wire guidance for major adverse cardiac events at one year, with improved resource utilization and reduced procedure time.
2026-03
Ctech
Medtronic to acquire Israeli AI cardiology firm CathWorks for $585 million, deal coul | Ctech
Medtronic announced its intent to acquire CathWorks for $585 million, following a strategic partnership initiated in 2022. The acquisition will integrate CathWorks' AI-based FFRangio system into Medtronic's cardiovascular portfolio.
2026-02
CathWorks
CathWorks Announces the Completion of Enrollment for Landmark ALL-RISE Randomized Controlled Trial
CathWorks successfully completed enrollment for its ALL-RISE randomized controlled trial, which is evaluating the clinical and economic benefits of the FFRangiou00ae System for diagnosing and treating coronary artery disease.
2025-01
PR Newswire
CathWorks Announces EU MDR Approval, Prominent Presence at EuroPCR and Full Launch of Co-promotion - PR Newswire
CathWorks announced that its FFRangiou00ae System received approval under the European Union Medical Device Regulation 2017/745 (EU MDR), fulfilling CE marking requirements.
2024-05
CathWorks
Fourth Generation CathWorks FFRangiou00ae System Receives Regulatory Approval in Japan
CathWorks announced that the fourth-generation FFRangiou00ae System received approval from the Japanese Pharmaceuticals and Medical Devices Agency (PMDA), expanding its commercial availability in Japan.
2022-10
CathWorks
Medtronic Announces Co-Promotion Agreement With CathWorks, With Path Toward Acquisition
Medtronic entered a strategic partnership and co-promotion agreement with CathWorks for the FFRangiou00ae System, with a potential path towards acquisition.
2022-07
CathWorks
CathWorks Announces $30 Million in New Financing
CathWorks completed a $30 million Series D financing round to expand the commercialization of its FFRangio system, a non-invasive diagnostic technology for coronary artery disease.
2021-01

Frequently Asked Questions

The CathWorks FFRangio System is a digital health innovation that combines artificial intelligence (AI) and advanced computational science to provide a comprehensive physiological assessment of coronary artery disease (CAD). It transforms routine angiograms into a 3D model of the coronary tree and calculates Fractional Flow Reserve (FFR) values at every point, eliminating the need for invasive pressure wires or hyperemic agents.
The FFRangio System has demonstrated high diagnostic accuracy, with a pooled analysis of five prospective studies showing 93% accuracy compared to invasive FFR. Clinical evidence, including the PROVISION Trial, has shown non-inferiority to wire-based FFR with similar revascularization rates and comparable one-year major adverse cardiac event (MACE) rates.
The CathWorks FFRangio System has received U.S. FDA 510(k) clearance, EU MDR approval, Israel Amar approval, and Japan PMDA approval. The company is also ISO 13485 and 27001 certified, demonstrating its commitment to quality and patient safety.
The FFRangio System streamlines procedural workflow by using routine 2D angiograms to generate real-time FFRangio values, integrating seamlessly with existing cath lab equipment and PACS. It minimizes risk and radiation exposure by eliminating the need for invasive pressure wires and drugs, while optimizing clinical decision-making with comprehensive physiological assessment and PCI planning tools.
CathWorks is a leader in digital health innovations, leveraging AI and advanced computational science to transform cardiovascular disease diagnosis and treatment. The company has a strategic partnership with Medtronic, which includes co-promotion of the FFRangio System globally and Medtronic's intent to acquire CathWorks for up to $585 million, indicating strong company stability and future integration into a major medical device portfolio.
The CathWorks FFRangio System has a dedicated CPT code, 0523T, for intraprocedural coronary FFR with 3D functional mapping. CathWorks is actively advocating with the Centers for Medicare & Medicaid Services (CMS) for consistent payment through a Software as a Service (SaaS) payment methodology and assignment to APC 5191 with status indicator 'J1' for Calendar Year 2025.
CathWorks has partnered with Quest International to provide global post-sales technical service support, including depot repairs, field services, and supply-chain logistics. This partnership ensures comprehensive and reliable support for CathWorks' growing customer base, complementing the intuitive user interface and fast learning curve of the FFRangio system.

Investors

Who's funded CathWorks.

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