HeartFlow Analysis
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
HeartFlow Analysis offers a non-invasive pathway to gain a comprehensive understanding of coronary artery disease (CAD) by combining anatomical and physiological insights from a single CCTA scan. This can significantly enhance diagnostic accuracy, reduce the need for unnecessary invasive procedures like cardiac catheterization, and enable more precise, personalized treatment planning for patients with suspected CAD. Utilize the FFRct values and plaque analysis to stratify risk and guide decisions on medical management versus revascularization, even in patients with non-obstructive CAD or zero calcium scores where plaque burden might still indicate risk.
HeartFlow is designed for seamless integration into existing clinical workflows. It supports deployment and configuration with PACS and EMR systems, allowing for efficient transfer of CCTA data and delivery of the personalized 3D models and analysis results directly to the physician's workstation. This integration aims to streamline coronary care, improve diagnostic efficiency, and facilitate timely clinical decision-making.
Details
| Category | Cardiology AI, Radiology & Imaging AI |
| Pricing |
Contact vendor for pricing
|
| Deployment | Cloud-based (AWS) |
| Compliance | |
| BAA Available | Yes AI-estimated |
| HIPAA Compliant | Yes AI-estimated |
| FDA Status |
Yes AI-estimated HeartFlow Analysis (K250902) is an AI-based medical device software for the clinical quantitative and qualitative analysis of previously acquired Computed Tomography DICOM data for adult patients (ages 22 years and older) with suspected coronary artery disease. |
| Integrations | |
| EHR | Not specified |
| Specialties | Cardiology, Radiology |
What the Web Says
HeartFlow Analysis is a non-invasive diagnostic tool that creates a personalized 3D model of a patient's coronary arteries to assess the impact of blockages on blood flow (fractional flow reserve or FFRct). It aims to improve diagnostic accuracy for coronary artery disease, reduce the need for invasive procedures like angiography, and guide treatment decisions. Reviews highlight its potential to streamline patient care pathways and provide more precise physiological information.
Overall: PositiveStrengths
- Reduces unnecessary invasive angiograms and associated risks/costs.
- Provides precise, patient-specific physiological data (FFRct) without invasive procedures.
- Improves diagnostic accuracy for coronary artery disease compared to traditional non-invasive tests.
- Aids in treatment planning, helping physicians determine if revascularization is truly needed.
- Non-invasive nature enhances patient comfort and safety.
- Potential to lower overall healthcare costs by optimizing patient pathways.
Limitations
- Cost of the analysis can be a barrier, though often covered by insurance.
- Requires a high-quality CT angiography scan as input, which has its own radiation exposure.
- Availability may be limited to institutions with the necessary infrastructure and physician training.
- Some physicians may prefer direct invasive FFR measurement for certain complex cases.
- Integration into existing clinical workflows can require adjustments.
- Potential for over-reliance on technology, diminishing clinical judgment in some views.
Based on reviews from: Physician reviews (various medical forums and journals), Healthcare IT publications, Reddit (r/medicine, r/cardiology), G2 (general tech reviews, though limited for medical devices), Capterra (general tech reviews, though limited for medical devices), Clinical trial publications (e.g., PLATFORM, DEFINE-FLOW)
Last updated: 2026-07-18
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Funded through the company that built this tool.
