HeartFlow Analysis

by HeartFlow  · Based in United States → — Decisive Coronary Care
Cardiology Radiology

Contact vendor for pricing
Regulatory Status Disclosed

Overview

HeartFlow Analysis is an AI-powered medical device software that transforms standard coronary computed tomography angiography (CCTA) images into a personalized, digital 3D model of a patient’s coronary arteries. This non-invasive diagnostic tool leverages advanced artificial intelligence and computational fluid dynamics (CFD) to simulate blood flow and assess the impact of blockages on coronary blood flow. The platform provides clinicians with detailed insights, including fractional flow reserve (FFRct) values, plaque localization and characterization, and anatomical data, to aid in the diagnosis, risk assessment, and treatment planning for coronary artery disease (CAD). It aims to improve diagnostic accuracy, reduce the need for unnecessary invasive procedures, and enable personalized care pathways for patients with suspected or known CAD.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • AI-powered 3D modeling of coronary arteries
  • Fractional Flow Reserve derived from CT (FFRct) analysis
  • Plaque Analysis (quantification and characterization)
  • Roadmapu2122 Analysis for CCTA reading
  • Non-invasive diagnostic assessment
  • Personalized patient insights
  • Computational Fluid Dynamics (CFD) for blood flow simulation
  • High diagnostic accuracy
  • Reduces need for unnecessary invasive procedures
  • Supported by extensive clinical evidence and guidelines

Use Cases

  • Diagnosing coronary artery disease (CAD)
  • Assessing the functional significance of coronary stenoses
  • Guiding treatment decisions (medical therapy, revascularization)
  • Risk stratification for major adverse cardiovascular events (MACE)
  • Reducing unnecessary invasive diagnostic coronary angiograms
  • Optimizing care pathways for patients with stable or acute chest pain

What Physicians Need to Know

Cardiac CT/MRI Analysis
HeartFlow Analysis specializes in the analysis of Cardiac CT (CCTA) images. It uses AI and computational fluid dynamics to create personalized 3D models of the coronary arteries, analyze blood flow (FFRCT), and characterize plaque.
Heart Failure Risk Prediction
While HeartFlow Analysis aids in diagnosing and managing Coronary Artery Disease (CAD), which can lead to heart failure, its primary stated function is not direct heart failure risk prediction. However, by providing detailed insights into plaque burden and blood flow, it can contribute to a more comprehensive risk assessment for cardiovascular events.
Coronary Artery Assessment
HeartFlow Analysis provides a comprehensive, non-invasive assessment of coronary arteries. It creates personalized 3D models from CCTA scans, measures the impact of plaque buildup on blood flow (FFRCT), and characterizes plaque by type (calcified, non-calcified, and low attenuation).
AHA/ACC Guideline Alignment
HeartFlow Analysis, including its FFRCT and Roadmap analysis, aligns with updated AHA/ACC chest pain guidelines. The ACC and AHA have also published scientific statements supporting the prognostic value of quantifying coronary plaque and reinforcing the role of CCTA + HeartFlow in CAD patient management.
Physician Tip

HeartFlow Analysis is a non-invasive tool that uses CCTA scans to provide a personalized 3D model of coronary arteries, assessing plaque and blood flow (FFRCT). This can help determine if a blockage is causing ischemia, potentially avoiding unnecessary invasive procedures like catheterization. The detailed insights into plaque characteristics and blood flow can guide treatment decisions, from lifestyle changes to revascularization. It is particularly useful for patients with suspected Coronary Artery Disease (CAD) where more clarity is needed after a standard CT scan. The HeartFlow Analysis is intended to be used in conjunction with the patient's clinical history, symptoms, and other diagnostic data, as well as the clinician's professional judgment.

HeartFlow Analysis integrates into the clinical workflow by processing CCTA images. The analysis results, including personalized models and plaque volumes, are delivered in a downloadable PDF report and can be integrated into PACS and EMR systems. The CCTA images are securely uploaded from the hospital's system to HeartFlow's software application.

Details

Category Cardiology AI, Radiology & Imaging AI
Pricing Contact vendor for pricing
DeploymentCloud-based (AWS)
Compliance
BAA Available Yes AI-estimated
HIPAA Compliant Yes AI-estimated
FDA Status Yes AI-estimated
Integrations
EHR Not specified
Specialties Cardiology, Radiology

What the Web Says

HeartFlow Analysis is a non-invasive diagnostic tool for coronary artery disease (CAD) that uses CT scan data, 3D modeling, and artificial intelligence to assess blood flow and the impact of blockages. It aims to provide a more comprehensive understanding of a patient's coronary disease burden, helping physicians determine the optimal course of treatment and potentially reduce the need for invasive procedures. The technology has received positive reviews from medical professionals and has been adopted by numerous hospitals, particularly in the UK's NHS.

Overall: Positive

Strengths

  • Non-invasive and safe, providing both anatomical and functional data.
  • High diagnostic accuracy, especially in identifying obstructive coronary disease and improving specificity compared to CCTA alone.
  • Can reduce the need for unnecessary invasive coronary angiography (ICA) and associated risks.
  • Helps physicians differentiate patients who need invasive procedures from those who can be managed with medication.
  • Provides a more comprehensive understanding of coronary disease, including plaque analysis and characterization.
  • Potential for cost savings in healthcare by avoiding costly, unnecessary procedures.

Limitations

  • Some CTCA datasets may be unsuitable for analysis due to technical issues like motion artifact or extensive calcification.
  • The cost of HeartFlow Analysis can be significant and may exceed that of performing a second in-house stress-based test.
  • Not all imaging centers that perform CCTA provide HeartFlow analysis.
  • Some Reddit discussions suggest that adoption might be limited in certain medical communities.
  • Employee reviews on platforms like Comparably and Indeed indicate mixed opinions on compensation and management, with some reporting low pay for the region.
  • Limited public reviews available on platforms like G2 and Capterra directly from users of the HeartFlow Analysis product.

Based on reviews from: heartflow.com, bjcardio.co.uk, nih.gov, auntminnie.com, medicaldevice-network.com, cardiovascularbusiness.com, elion.health, greatplacetowork.com, comparably.com, indeed.com, dicardiology.com, fda.gov, g2.com, sgno.org, ihirehealthcareadministration.com, scot.nhs.uk, medaiverdict.com, stocktitan.net, reddit.com, sourceforge.net, expertini.com, softwareadvice.com, capterra.com, cardiovascularnews.com

Last updated: 2026-10-30

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Press & Coverage

HeartFlow Investor Relations
Heartflow to Report Third Quarter 2026 Financial Results on November 12, 2026
HeartFlow, Inc. announced it will release its third-quarter 2026 financial results after market close on Thursday, November 12, 2026, followed by a conference call to discuss the results.
2026-10
AuntMinnie.com
Heartflow sues Elucid over cardiac CT patents, trade secrets
HeartFlow has filed a lawsuit against Elucid, alleging infringement of four patents and misappropriation of trade secrets related to its CT-derived fractional flow reserve (FFR) product.
2026-10
Investing.com
Heartflow Inc stock reached an all-time high of 60.07 USD
HeartFlow Inc. stock hit an all-time high of $60.07, reflecting strong investor confidence and positive market sentiment, with a 98% year-to-date return.
2026-10
WakeMed
WakeMed Expands Cardiac Care with Heartflow Analysis to Advance Early Detection of Coronary Artery Disease
WakeMed is now offering HeartFlow Analysis, an AI-enabled technology that provides a precise, non-invasive method for evaluating coronary artery disease, enhancing early detection and personalized treatment planning.
2026-06
HeartFlow Investor Relations
New Data at SCCT 2026 Reinforce Heartflow Plaque Analysis as the Standard for AI-Powered Coronary Artery Disease Management
HeartFlow announced eight new datasets from clinical studies involving over 36,000 patients would be presented at SCCT 2026, reinforcing HeartFlow Plaque Analysis as a standard for AI-powered CAD management.
2026-07
HeartFlow Investor Relations
Heartflow Files Patent Infringement Lawsuit Against Cleerly
HeartFlow, Inc. filed a patent infringement lawsuit against Cleerly, Inc., asserting that Cleerly's products infringe on foundational patented technology central to the HeartFlow Platform.
2026-04
Cardiovascular Business
Heartflow Reports First Quarter 2026 Financial Results
HeartFlow reported significant increases in total revenue and U.S. revenue for the first quarter of 2026, driven by growing demand for its AI analysis software for CCTA images.
2026-05
HeartFlow Investor Relations
Heartflow Builds Evidence Base Across the Heart Disease Care Continuum, From Precision Risk Stratification to CT-Guided Intervention Planning
HeartFlow announced new clinical evidence and a landmark registry launch at the American College of Cardiology Annual Scientific Session, advancing its vision for CAD management.
2026-03

Videos

Product demos, reviews, and walkthroughs for HeartFlow Analysis.

View all on YouTube

Frequently Asked Questions

HeartFlow Analysis utilizes advanced artificial intelligence and computational fluid dynamics to create a personalized 3D digital model of a patient's coronary arteries from a standard coronary CT angiogram (CCTA). This AI-powered approach simulates blood flow and assesses the impact of any blockages, providing physicians with detailed functional and anatomical data to aid in diagnosing coronary artery disease (CAD) and guiding treatment decisions.
HeartFlow Analysis has certain limitations, including that its safety and effectiveness have not been evaluated in patients with acute coronary syndrome, recent myocardial infarction (within 30 days), complex congenital heart disease, prior coronary artery bypass graft (CABG) surgery, or a BMI over 35. It is also not clinically evaluated for patients with intracoronary metallic stents, pacemakers, prosthetic heart valves, significant arrhythmias, or excessive coronary calcification. The analysis relies on the quality of the CT data, and the absence of nitrates during CCTA acquisition may adversely affect accuracy.
HeartFlow Analysis is reimbursed by the Centers for Medicare & Medicaid Services (CMS) and most major commercial insurers. As of January 1, 2024, the American Medical Association (AMA) established a Category I CPT code for the FFRCT Analysis, reinforcing its inclusion in AHA Chest Pain Guidelines. HeartFlow also meets international standards for quality systems, global security, and patient data integrity, including HITRUST, SOC 2 Type 2, ISO 13485, and ISO 27001.
Alternatives to HeartFlow Analysis in the realm of medical 3D visualization and AI-powered CT analysis include Cleerly, which primarily focuses on plaque composition analysis, and other software platforms like 3D Slicer, Ansys Simpleware, Invivo5, OsiriX MD, and Materialise Mimics Care Suite. These tools offer various functionalities such as medical image segmentation, 3D modeling, and virtual surgical planning.
Clinical studies have shown that HeartFlow FFRCT Analysis demonstrates higher diagnostic performance compared to other non-invasive cardiac tests. For instance, in one study, FFRct Analysis achieved a diagnostic performance score of 0.94, outperforming PET (0.87), coronary CTA (0.83), and SPECT (0.70). It provides both anatomical and functional data, improving the specificity of CAD diagnosis compared to CCTA alone.

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

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