QFR

Cardiology

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Regulatory Status Disclosed

Overview

QFR by QFR Solutions bv is a medical software device designed for the visualization and advanced analysis of X-ray angiographic images, specifically focusing on coronary vessel segments. It utilizes artificial intelligence to perform calculations and reconstruct 3D models of coronary arteries, enabling quantitative assessment of lesions and determination of their functional significance through Quantitative Flow Ratio (QFR) analysis. Key AI capabilities include automated end-diastolic frame selection and precise alignment of angiographic projections. This tool is intended to support cardiologists and radiologists in clinical decision-making regarding the diagnosis and treatment of coronary artery disease. It is important to note that this tool is a cardiology imaging analysis software and not an AI tool for a physician directory.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Visualization of X-ray angiographic images
  • Analysis and calculations in coronary vessel segments
  • Automatic detection and editing of vessel contours
  • 3D reconstruction of coronary vessel models
  • Accurate anatomical quantification of lesions
  • Quantitative Flow Ratio (QFR) assessment for functional significance
  • AI-enabled end-diastolic frame selection
  • Deep learning for precise alignment of angiographic projections
  • Non-invasive (no pressure wire, no adenosine required)
  • Applicable online and/or offline, pre-, during-, and post-PCI

Use Cases

  • Support clinical decision-making for diagnosis and treatment of coronary vessels
  • Evaluate interventions or drug therapy for coronary conditions
  • Assess functional severity and guide revascularization decisions for epicardial artery stenosis
  • Aid in precise lesion selection in multivessel disease
  • Assist in managing patients with chronic heart failure
  • Provide quality assessment of stent placement after PCI

What Physicians Need to Know

Evidence Base
Medis QFR is supported by a robust evidence base, including numerous peer-reviewed articles and clinical trials. It is incorporated into the 2024 European Society of Cardiology (ESC) guidelines with a Class IB recommendation for assessing epicardial artery stenosis and a Class IA recommendation for selecting lesions in patients with multivessel disease. The technology leverages 3D Quantitative Coronary Angiography (QCA) and flow velocity for its assessments.
Clinical Validation Studies
QFR has demonstrated strong correlation and diagnostic accuracy (typically 86-93%) when compared to Fractional Flow Reserve (FFR), the gold standard. Key studies like FAVOR II China and FAVOR III China have shown superior clinical outcomes for QFR-guided revascularization compared to angiography-guided approaches. However, the FAVOR III Europe trial indicated that a QFR-guided strategy resulted in higher revascularization rates and did not meet non-inferiority to FFR for clinical outcomes, prompting ongoing discussions regarding guideline recommendations. Ongoing trials such as PIONEER IV and DECISION QFR continue to investigate its impact on clinical outcomes and decision-making.
Differential Diagnosis Support
QFR provides specialized support for diagnosing the functional significance of coronary artery lesions. It helps physicians differentiate between lesions requiring percutaneous coronary intervention (PCI) and those that can be managed medically, with a common cutoff of QFR < 0.80 indicating significant stenosis. It also supports the evaluation of interventions or drug therapy applied for conditions of the coronary vessels.
Guideline Update Frequency
The role and recommendations for QFR are actively reviewed and updated by major cardiology organizations. Significant updates were introduced in the 2024 ESC Guidelines, reflecting its evolving position in clinical practice.
Clinical Workflow Integration
QFR is designed for seamless integration into the cath lab workflow, enabling both real-time and offline analysis of angiographic images. It streamlines procedures by eliminating the need for invasive pressure wires and hyperemic agents like adenosine, potentially reducing procedure time, costs, and patient discomfort. The software supports automated detection and 3D vessel model reconstruction from two angiographic projections.
Physician Tip

Utilize QFR for a non-invasive assessment of intermediate coronary lesions to guide revascularization decisions, leveraging its established cutoff values (e.g., <0.80 for significant stenosis, >0.90 post-PCI for successful intervention). Consider QFR for both immediate and retrospective analysis of angiograms to enhance decision-making. While QFR offers significant advantages in efficiency and reduced invasiveness, be mindful of ongoing research and guideline discussions, and consider a hybrid approach with FFR for equivocal cases to ensure comprehensive patient care. Explore its capability to assess microcirculation (angio-IMR) for a more holistic understanding of coronary artery disease.

Medis QFR software can be installed on standard PCs or laptops and is capable of receiving DICOM images directly from enterprise cath lab systems and PACS for efficient data flow. Exclusive integrations with imaging systems, such as GE IGS, are available to further optimize workflow speed and efficiency within the cath lab environment.

Details

Category Cardiology AI, Radiology & Imaging AI
Pricing Contact for quote — N/A
DeploymentOn-premise / Integrated with cath lab systems
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

QFR (3.0) is an X-Ray Angiographic Imaging Based Coronary Vascular Simulation Software Device, cleared by the FDA under 510(k) Premarket Notification K243769.

Integrations
EHR Not specified
Specialties Cardiology

What the Web Says

QFR, offered by Medis Imaging, is a quantitative flow ratio analysis software designed for coronary artery disease assessment. Reviews from physicians and tech sources highlight its potential to improve diagnostic accuracy and aid in treatment planning, particularly in the cath lab setting. While generally well-received for its innovation, some users point out the learning curve and integration challenges.

Overall: Positive

Strengths

  • Non-invasive physiological assessment of coronary arteries
  • Aids in decision-making for revascularization
  • Potentially reduces need for pressure wires (FFR)
  • Provides objective quantitative data
  • Integration with existing angiography systems
  • Improved diagnostic accuracy for CAD

Limitations

  • Steep learning curve for new users
  • Requires high-quality angiographic images for accurate analysis
  • Potential for inter-observer variability in image selection
  • Integration challenges with diverse hospital IT systems
  • Cost of software and associated training
  • Limited long-term outcome data compared to traditional FFR

Based on reviews from: Medis Imaging Website, Cardiology Journals/Research Papers, Healthcare IT Review Sites (e.g., G2, Capterra - limited specific reviews found for QFR), Physician Forums/Discussions (e.g., Reddit - limited specific discussions found for QFR), Medical Device Review Platforms

Last updated: 2026-07-21

Ratings & Reviews

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Press & Coverage

HMP Global Learning Network
Medis QFR 3.0 Launches in the U.S.
Medis Medical Imaging announced FDA clearance of Medis QFRu00ae 3.0 in the USA, an AI and Deep Learning-powered, wire-free software solution for assessing angiography-derived coronary physiology in patients with ischemic CAD. This latest version includes significant automation and enhancements while maintaining accuracy.
2025-04
medisimaging
Another Major Study Reinforces Angiography-Derived Physiology as a Simpler Path to Optimal PCI
A new study, PIONEER IV, published in the European Heart Journal, confirms the non-inferiority of QFR-guided PCI compared to usual care, including FFR, iFR, IVUS, and OCT guidance. This reinforces angiography-derived physiology as a simpler path to optimal percutaneous coronary intervention.
2026-03
medisimaging
Medis Appoints Kevin DeMoss as VP Commercial QFR u2013 North America to Support Clinical Adoption of Angiography Derived Coronary Physiology in the region
Medis Medical Imaging appointed Kevin DeMoss as VP Commercial QFR u2013 North America to support the clinical adoption of angiography-derived coronary physiology in the region. This move aims to expand the reach of their AI-powered cardiovascular imaging solutions.
2026-02
Cardiovascular News
GE HealthCare and Medis Medical collaborate to commercialise QFR technology
GE HealthCare and Medis Medical Imaging announced a collaboration to advance precision care in diagnosing and treating coronary artery disease by commercializing Medis Quantitative Flow Ratio (Medis QFR) technology. This partnership integrates Medis QFR into GE HealthCare's interventional cardiology portfolio, aiming to streamline cath lab workflows.
2024-05
Cardiovascular News
Terumo brings Medis QFR 3.0 to US market
Terumo Health Outcomes, a division of Terumo Interventional Systems, announced that Medis QFR 3.0, an FDA-cleared software solution, is now available in the USA through its collaboration with Medis Medical Imaging. This partnership aims to enhance cath lab efficiency and support high-quality, patient-centered care.
2025-04
medisimaging
QFRu00ae awarded Class I recommendation in 3 categories of the 2024 ESC guidelines for the management of Chronic Coronary Syndrome
Medis' Quantitative Flow Ratio (QFRu00ae) received a Class I recommendation in three categories of the 2024 ESC guidelines for managing chronic coronary syndrome. This recognition places QFRu00ae at par with traditional wire-based methods for physiological measurement.
2024-10
medisimaging
Medis QFRu00ae now reimbursed in Japan
Medis QFRu00ae received reimbursement approval from the Japanese Ministry of Health as of January 1st, 2024, following PMDA approval in August 2023. This milestone allows Japanese healthcare professionals to integrate the non-invasive, image-based coronary physiology assessment into clinical practice.
2024-01
Circulation: Cardiovascular Imaging - American Heart Association Journals
Evaluation of Coronary Artery Stenosis by Quantitative Flow Ratio During Invasive Coronary Angiography
The WIFI II substudy of the Dan-NICAD study evaluated the feasibility and diagnostic performance of QFR in unselected patients, showing good agreement and diagnostic accuracy compared with FFR. QFR correctly classified 83% of lesions using FFR with a cutoff at 0.80 as the reference standard.
2018-03

Videos

Product demos, reviews, and walkthroughs for QFR.

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Frequently Asked Questions

QFR seamlessly integrates into the PCI workflow by utilizing standard angiographic images to reconstruct 3D vessel models and calculate stenosis severity. This wire-free and adenosine-free method provides immediate physiological assessment, guiding decisions on whether to stent a lesion and potentially reducing unnecessary procedures.
QFR is supported by strong clinical evidence from large-scale randomized trials, such as FAVOR III China, demonstrating improved patient outcomes compared to angiography-guided PCI. The 2024 European Society of Cardiology (ESC) guidelines highlight QFR with Class I recommendations for assessing epicardial artery stenosis and guiding revascularization in multivessel disease.
QFR demonstrates good diagnostic accuracy compared to FFR, with studies showing strong correlation and similar clinical outcomes in guiding PCI. It is superior to visual angiography in identifying functionally significant stenoses, offering a less invasive alternative by eliminating the need for pressure wires and hyperemic agents, which can reduce patient discomfort and procedure time.
Implementing QFR can lead to reduced procedural costs by eliminating the need for expensive pressure wires and hyperemic drugs like adenosine. Studies suggest that QFR-guided PCI can be cost-effective by reducing the rate of unnecessary interventions and improving long-term patient outcomes, potentially lowering overall healthcare expenditures.
The accuracy of QFR can be influenced by the quality of angiographic images, with challenges arising from vessel overlap, tortuosity, or insufficient contrast injection. Its diagnostic performance may also be affected in patients with microcirculatory dysfunction or severe aortic stenosis.
QFR technology generally has a relatively short learning curve, with operators achieving improved accuracy and faster measurement times after approximately 200 measurements. Training typically involves understanding the software interface, proper angiographic image acquisition techniques, and interpretation of QFR values for clinical decision-making.
Yes, QFR software is designed to receive DICOM images from existing cath lab systems and PACS, facilitating its integration into current imaging workflows. For broader data exchange and interoperability with EHRs, systems often leverage standards like FHIR to ensure seamless data flow and support comprehensive patient records.

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Suggest an Edit → | Last Verified: 2026-04-20 | First Added: 2026-04-20
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