FFR CT Analysis
Non-invasive assessment of blood flow to determine benefit of revascularization
Software · Cloud SaaSCompany source
Company profile
About HEARTFLOW
HeartFlow is transforming the diagnosis and management of coronary artery disease (CAD) worldwide through its AI-powered analysis platform. The company's vision is to transform CAD from the leading cause of death into a disease that can be managed for life. HeartFlow's first-of-its-kind AI analysis creates detailed 3D models of the heart from coronary computed tomography angiography (CCTA) scans, providing a window into patients' futures and empowering clinicians with insights to personalize each treatment journey. The HeartFlow One platform combines three core analysis capabilities: Roadmap Analysis for efficient and accurate CAD detection, FFR CT Analysis to assess blood flow and determine revascularization benefit, and Plaque Analysis to quantify and characterize plaque for risk stratification and disease management. This comprehensive approach addresses the limitations of conventional diagnostic methods, which have 20-30% false negative rates leading to undetected disease and 55% false positive rates resulting in unnecessary procedures. HeartFlow has treated over 650,000 patients across more than 1,800 institutions globally, with 99.5% of US lives covered by reimbursement. The platform is backed by over 625 peer-reviewed publications demonstrating clinical validity and improved patient outcomes. HeartFlow serves cardiologists, radiologists, and healthcare systems seeking to build efficient and scalable CCTA programs with comprehensive clinical, operational, technical, and financial support.
Company description HEARTFLOW official website
Primary marketCardiology & Cardiovascular Health
Commercial modelCommercial information available on request
Company presenceOfficial website
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01 · Operating footprint
Where the Company operates
Company-profile context for clinical focus, customers, deployment, integration, milestones, and partnerships.
Clinical focus
- Acute chest pain
- Coronary artery disease
- Non-obstructive CAD
- Obstructive CAD
- Stable chest pain
Who it serves
- Cardiology practices
- Health Systems
- Hospitals
- Imaging centers
Deployment & integration
Cloud Saas · Hybrid deployment with recorded integration context.
Geographic context
MarketsCanada · European Union · Japan · United Kingdom · United States
Company sourceOfficial website
Company milestones
Platform expansion
Heartflow Plaque Analysis supported by scientific statements from American College of Cardiology and American Heart Association. AHA 2025 late-breaking data reinforced prognostic power of AI-driven Plaque Analysis. Expanded evidence base across heart disease care continuum from precision risk stratification to CT-guided intervention planning.
Partnerships
Recorded partners
No partners are currently listed.
02 · Flagship portfolio
Products, workflows, and platform capabilities
Selected source-backed Company products and the available commercial context.
Heartflow One Platform
AI-powered platform transforming CCTA scans into personalized 3D heart models for CAD management
Platform · Cloud SaaSCompany source
HeartFlow Support
Clinical, operational, technical and financial resources to build scalable CCTA programs
Service · HybridCompany source
PCI Navigator
CT-guided intervention planning tool for percutaneous coronary intervention procedures
Software · Cloud SaaSCompany source
Plaque Analysis
Quantify and characterize plaque to inform risk and manage disease
Software · Cloud SaaSCompany source
Roadmap Analysis
AI-enabled efficient CCTA reading with consistent results for fast, accurate CAD detection
Software · Cloud SaaSCompany source
03 · Research intelligence
Research Intelligence evidence
Publications, preprints, clinical validation, and regulatory records in Evidence Position order.
Evidence position
Publications, clinical validation, and regulatory records connected to this Company appear here.
Research
Publications & preprints
CCTA characterization of coronary atherosclerosis diffuseness and focality using FFR-CT and plaque burden: results from the PRECISE trial.European journal of radiology · Aug 22, 2026
Reproducibility of AI-Informed Coronary Computed Tomography Angiography-Derived Coronary Plaque Volume Quantification.JACC. Advances · Jul 11, 2026
Prevalence and burden of coronary artery disease in young adults undergoing clinically indicated coronary CT angiography.Open heart · Jul 9, 2026
A study to measure the utility of an AI-enhanced reporting tool in assisting busy CCTA readers with REPORT generation (SMART-REPORT).BMC medical imaging · Jul 3, 2026
Guiding Preventive Care Strategies for Patients With Atherosclerotic Plaque on Coronary CTA: Primary Outcomes of the DECIDE Registry.JACC. Cardiovascular imaging · Jun 1, 2026
The Importance of Age in Selecting a Testing Strategy for Stable Symptomatic Patients With Suspected Coronary Artery Disease.Journal of the American Geriatrics Society · Jun 1, 2026
Clinical validation
Clinical-trial records
Coronary Computed Tomography Angiography (CCTA) for the Pre-procedural Planning of Percutaneous Coronary InterventionNCT07691502 · Sponsor · RECRUITING
Assessing Diagnostic Value of Non-invasive FFR-CT in Coronary Care in the Emergency DepartmentNCT05325112 · Sponsor · TERMINATED
Changes in Plaque Characteristics After Short-term Statin Therapy as Assessed With Coronary CTNCT06603363 · Sponsor · RECRUITING
Non-invasive Diagnosis of Coronary Microvascular Disease: Pilot StudyNCT06070662 · Mentioned · RECRUITING
The NAVIGATE-PCI Registry: A New Approach to VIew CT-derived Guidance Ahead of Stenting To Plan Efficient PCINCT07479433 · Sponsor · RECRUITING
RElugolix VErsus LeUprolide Cardiac TrialNCT05320406 · Mentioned · ACTIVE NOT RECRUITING
Regulatory
Regulatory records
HeartFlow AnalysisK250902 · 510k · Jul 18, 2025
HeartFlow AnalysisK213857 · 510k · Oct 14, 2022
HeartFlow AnalysisK203329 · 510k · Jan 8, 2021
HeartFlow FFRct AnalysisK190925 · 510k · Aug 15, 2019
FFRctK182035 · 510k · Dec 6, 2018
FFRctK161772 · 510k · Aug 24, 2016
04 · Company-reported outcomes
Outcomes and case studies
Company-reported outcomes and customer stories are distinct from linked Research Intelligence evidence.
20-30% reduction in false negatives
Compared to conventional diagnostic methods like stress EKG, stress echo, PET, calcium score, SPECT
55% reduction in false positives
Compared to conventional diagnostic methods leading to unnecessary procedures
25% reduction in read times
SMART-CT study with Roadmap Analysis
41% reduction in coronary heart disease death or nonfatal MI at 5 years
SCOT-HEART trial comparing CCTA to standard care
14% reduction in hospital stays
Meta-analysis of 22 trials for acute chest pain evaluation
17% reduction in immediate costs
Meta-analysis for acute chest pain evaluation
87% sensitivity, 81% specificity per vessel
PACIFIC trial FFR CT vs invasive FFR
95% event-free survival over 7+ years
CONFIRM Registry for patients with normal CCTA results
PRECISE Trial (2,103 patients)
Comparing CCTA + FFR CT against standard care for stable chest pain patients
78% more effective at identifying patients with disease and 69% reduction in negative diagnostic-only catheterizations
PRECISE Trial Sites
Comparing CCTA + FFR CT against standard care for stable chest pain diagnosis
78% more effective at identifying patients with disease and 69% reduction in negative diagnostic-only catheterizations
SMART-CT Study
Evaluating impact of Roadmap Analysis on CCTA interpretation efficiency and accuracy
25% reduction in read times and improved inter-reader agreement while maintaining diagnostic accuracy
ADVANCE Registry (5,083 patients, 38 sites)
Examining prognostic value of FFR CT for treatment planning and risk stratification
Patients with normal FFR CT showed 85% lower revascularization rates (5.6% vs 38.4%) and 75% lower cardiovascular death/MI rates (0.2% vs 0.8%)
ADVANCE Registry Sites
Examining prognostic value of FFR CT across 5,083 patients at 38 international sites
Patients with normal FFR CT showed 85% lower revascularization rates (5.6% vs 38.4%) and 75% lower cardiovascular death/MI rates (0.2% vs 0.8%)
PLATFORM Study
Evaluating clinical and economic impact of CCTA + FFR CT versus standard care in suspected CAD
83% reduction in negative diagnostic catheterizations and 33% reduction in healthcare costs
PLATFORM Study Sites
Evaluating clinical and economic impact of CCTA + FFR CT versus standard care in suspected CAD
83% reduction in negative diagnostic catheterizations and 33% reduction in healthcare costs
Image One
Using Coronary CTA with HeartFlow One to understand disease severity from non-obstructive to severe disease requiring intervention
Improved understanding of disease progression and intervention needs across the full spectrum of CAD severity
05 · Leadership
Leadership team
Leadership profiles and professional links from the current Company record.
06 · Company updates
Updates from HEARTFLOW
Recent articles published on HEARTFLOW's official website.
No Company updates are currently listed.
07 · HAIC coverage
Coverage and analysis
Health AI Central reporting that mentions this Company.
No HAIC coverage is currently linked to this Company.
08 · Official presence
Company sources and channels
Curated official destinations from the active Company record.
09 · Market pathway
Additional Companies in this Market
Other active Companies in the same market, selected alphabetically from the HAIC directory.
Market context
Cardiology & Cardiovascular Health
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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Linked research, clinical, and regulatory source pathways.
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