CathWorks FFRangio System
AI-powered, drug-free and wire-free physiologic assessment for coronary arteries
Company profile
Company profile
CathWorks is a global leader in digital health innovations focused on transforming how cardiovascular disease is diagnosed and treated. The company's flagship product, the CathWorks FFRangio System, combines artificial intelligence and advanced computational science to obtain physiologic information from routine angiograms, eliminating the need for drug stimulation and invasive pressure wires. The system provides physicians with quick and reliable intraprocedural FFRangio values for the entire coronary tree, enabling comprehensive physiologic assessment across multiple vessels. The FFRangio System delivers real-time FFRangio values at every point on the coronary tree, simulated pullback curves to differentiate functional patterns of coronary artery disease, and integrated sizing tools for non-invasive lesion measurements. The technology has been adopted by major health systems across the United States and internationally, with institutions like Lenox Hill Hospital performing over 1,000 cases. CathWorks is now part of Medtronic, expanding its reach to improve patient outcomes globally. The company is dedicated to partnering with physicians to improve patient health through innovative cardiovascular diagnostic solutions.
Company description CathWorks Ltd official website
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01 · Operating footprint
Company-profile context for clinical focus, customers, deployment, integration, milestones, and partnerships.
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Company milestones
Acquired by Medtronic (2025), ALL-RISE Global Study completed enrollment of 1,927 patients (2025), PROVISION Trial results presented at ACC.26 (2025), EU-MDR approval received (2024), 4th generation FFRangio System launched (2021), Lenox Hill Hospital reached 1,000 FFRangio cases milestone
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02 · Flagship portfolio
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AI-powered, drug-free and wire-free physiologic assessment for coronary arteries
03 · Research intelligence
Publications, preprints, clinical validation, and regulatory records in Evidence Position order.
Publications, clinical validation, and regulatory records connected to this Company appear here.
Research
Circulation. Cardiovascular interventions · Sep 1, 2017
Clinical validation
NCT05893498 · Sponsor · ACTIVE NOT RECRUITING
FFRangio Accuracy vs. Standard FFRNCT03226262 · Sponsor · COMPLETED
Angiogram Based Fractional Flow Reserve in Patients With Multi-Vessel DiseaseNCT03455244 · Sponsor · COMPLETED
Angiogram Based Fractional Flow Reserve FFRangio - A Validation StudyNCT03005028 · Sponsor · COMPLETED
Regulatory
K192442 · 510k · Dec 9, 2019
FFRangio SystemK182149 · 510k · Dec 19, 2018
04 · Company-reported outcomes
Company-reported outcomes and customer stories are distinct from linked Research Intelligence evidence.
PROVISION Trial and ALL-RISE study results
Non-invasive physiologic assessment
Entire coronary tree evaluation in single procedure
AI-driven technology implementation to improve heart care
Improved heart health care delivery in Flagler County
Integration of CathWorks FFRangio System for coronary artery disease assessment
System-wide adoption announced; FFRangio accelerated culture of collaboration in cath lab
Accelerated culture of collaboration in cath lab with FFRangio technology
Improved cath lab collaboration
Advanced procedural modeling and comprehensive data integration for precision-driven decision-making
Enhanced workflow efficiency, optimized procedural planning, and better patient outcomes
First in US to perform 1,000 FFRangio cases for coronary physiologic assessment
1,000 FFRangio cases completed - historic milestone
Comprehensive hemodynamics and physiology assessment for better patient understanding
More detailed assessment compared to quick lesion evaluation, improving physician collaboration
AI-powered heart testing with less invasive approach for accurate cardiac data
More accurate data in a less invasive way
Non-invasive diagnostic assessment with similar accuracy to invasive measures
Similar diagnostic accuracy and outcomes without need for wires or adenosine
05 · Leadership
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06 · Company updates
Recent articles published on CathWorks Ltd's official website.
07 · HAIC coverage
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08 · Official presence
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09 · Market pathway
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Market context
Companies applying AI to cardiovascular disease detection, ECG/EKG analysis, heart failure management, cardiac imaging, arrhythmia detection, or cardiovascular risk assessment. Includes AI-powered cardiac diagnostics, non-invasive hemodynamic monitoring, and tools for early detection and personalized management of heart conditions.
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