HeartFlow Plaque Analysis

JSON twin: https://www.healthaidb.com/software/heartflow-plaque-analysis.json

Company Name

HeartFlow

Product URL

https://www.heartflow.com/plaque-new/

Company URL

https://www.heartflow.com

Categories

• diagnostic Support
• clinical Care
• patient Facing
• Diagnostic
• Clinical

Summary

HeartFlow Plaque Analysis is an AI-powered tool that non-invasively quantifies and characterizes coronary artery plaque to aid in diagnosing and managing coronary artery disease (CAD).

Description

HeartFlow Plaque Analysis utilizes proprietary algorithms to analyze coronary CT angiogram (CCTA) scans, creating personalized 3D models that quantify and characterize plaque volume in coronary arteries, assisting in CAD risk assessment. The platform integrates with FFR_{CT} values when performed, offering comprehensive insights for clinical decision-making and personalized patient treatment plans. It has received FDA 510(k) clearance and is covered by major insurers, including UnitedHealthcare and Cigna, enhancing its accessibility for patients and clinicians. ([ir.heartflow.com](https://ir.heartflow.com/news-releases/news-release-details/heartflow-announces-fda-510k-clearance-and-launch-next?utm_source=openai))

Api Available

yes

Certifications

• FDA 510(k)
• CE Mark
• PMDA (Japan) approval
• Health Canada medical device licensing

Company Founding

2014

Company Offices

• United States

Compliance

• HIPAA
• GDPR
• HITECH
• HITRUST
• ISO 27001
• SOC 2

Customers

• Cigna Health Insurance

Data Residency

US/EU regions

Data Standards

• DICOM
• HL7 v2
• FHIR
• IHE profiles
• SNOMED
• ICD-10

Deployment Model

• SaaS
• cloud-based

Features

• FFRCT (lesion-specific physiologic assessment)
• 3D patient-specific coronary anatomy reconstruction
• Color-coded FFR values and interactive 3D viewer
• Lesion localization and sequential lesion evaluation
• Planner (treatment planning / virtual PCI planning)
• Roadmap visualization of coronary lesions
• Plaque analysis (plaque burden and composition)
• Pins/measurements along coronary tree
• Automated report generation
• Rapid turnaround (median ~90 minutes)

Id

SW0401

Integration Partners

• 3D Slicer
• Simpleware
• Invivo5
• OsiriX MD
• Materialise Mimics Care Suite
• D2P (DICOM to PRINT)
• Axial3D | Medical 3D Printing
• MiNNOVAA PACS

Integrations

• Epic
• Cerner
• PACS vendors
• Hospital IT/enterprise imaging teams
• Clinical research and registry partners

Languages Supported

• English

Last Updated

2025-10-11

License

commercial

Market Segment

• enterprise
• smb

Optional Modules

• Plaque Analysis
• FFRCT Analysis
• Roadmap Analysis
• Planner

Os Platforms

• Web

Pricing Details

Contact vendor for pricing information.

Pricing Model

subscription

Privacy Features

• BAA available
• consent mgmt
• anonymization
• data minimization

Product Code

SW0401

Product Name

HeartFlow Plaque Analysis

Ratings

• 4.5 out of 5 on G2 ([g2.com](https://www.g2.com/products/heartflow/competitors/alternatives?utm_source=openai))
• 4.4 out of 5 on G2 ([g2.com](https://www.g2.com/products/heartflow/competitors/alternatives?utm_source=openai))
• 4.3 out of 5 on G2 ([g2.com](https://www.g2.com/products/heartflow/competitors/alternatives?utm_source=openai))
• 4.1 out of 5 on G2 ([g2.com](https://www.g2.com/products/heartflow/competitors/alternatives?utm_source=openai))
• 4.7 out of 5 on G2 ([g2.com](https://www.g2.com/products/heartflow/competitors/alternatives?utm_source=openai))
• 4.8 out of 5 on G2 ([g2.com](https://www.g2.com/products/heartflow/competitors/alternatives?utm_source=openai))

Regions Available

• United States

Related Urls

• https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices

Release Year

2025

Security Features

• Encryption
• RBAC
• SSO/SAML
• audit logs
• 2FA
• DLP

Specialties

• Cardiology

Support Channels

• email
• phone
• chat
• ticketing
• community
• 24x7

System Requirements

Target Users

• clinicians
• patients

Training Options

• documentation
• webinars
• live_online
• onsite
• certification

Type

product

User Reviews

• HeartFlow's Plaque Analysis has significantly improved our diagnostic accuracy, leading to better patient outcomes.
• The 3D visualization feature provides a clear understanding of plaque distribution, enhancing our treatment planning.
• Integrating HeartFlow's platform into our workflow was seamless, and the support team was highly responsive.
• The AI-driven insights have streamlined our decision-making process, making it more efficient.
• HeartFlow's Plaque Analysis has become an indispensable tool in our cardiology department.

Version

1.0

Alternatives

See related products

Canonical JSON

{
  "product_name": "HeartFlow Plaque Analysis",
  "company_name": "HeartFlow",
  "product_url": "https://www.heartflow.com/plaque-new/",
  "company_url": "https://www.heartflow.com",
  "related_urls": [
    "https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"
  ],
  "product_code": "SW0401",
  "summary": "HeartFlow Plaque Analysis is an AI-powered tool that non-invasively quantifies and characterizes coronary artery plaque to aid in diagnosing and managing coronary artery disease (CAD).",
  "description": "HeartFlow Plaque Analysis utilizes proprietary algorithms to analyze coronary CT angiogram (CCTA) scans, creating personalized 3D models that quantify and characterize plaque volume in coronary arteries, assisting in CAD risk assessment. The platform integrates with FFR_{CT} values when performed, offering comprehensive insights for clinical decision-making and personalized patient treatment plans. It has received FDA 510(k) clearance and is covered by major insurers, including UnitedHealthcare and Cigna, enhancing its accessibility for patients and clinicians. ([ir.heartflow.com](https://ir.heartflow.com/news-releases/news-release-details/heartflow-announces-fda-510k-clearance-and-launch-next?utm_source=openai))",
  "categories": [
    "diagnostic Support",
    "clinical Care",
    "patient Facing",
    "Diagnostic",
    "Clinical",
    "Patient-facing"
  ],
  "market_segment": [
    "enterprise",
    "smb"
  ],
  "target_users": [
    "clinicians",
    "patients"
  ],
  "specialties": [
    "Cardiology"
  ],
  "regions_available": [
    "United States"
  ],
  "languages_supported": [
    "English"
  ],
  "pricing_model": "subscription",
  "pricing_details": "Contact vendor for pricing information.",
  "license": "commercial",
  "company_offices": [
    "United States"
  ],
  "company_founding": "2014",
  "deployment_model": [
    "SaaS",
    "cloud-based"
  ],
  "os_platforms": [
    "Web"
  ],
  "features": [
    "FFRCT (lesion-specific physiologic assessment)",
    "3D patient-specific coronary anatomy reconstruction",
    "Color-coded FFR values and interactive 3D viewer",
    "Lesion localization and sequential lesion evaluation",
    "Planner (treatment planning / virtual PCI planning)",
    "Roadmap visualization of coronary lesions",
    "Plaque analysis (plaque burden and composition)",
    "Pins/measurements along coronary tree",
    "Automated report generation",
    "Rapid turnaround (median ~90 minutes)"
  ],
  "optional_modules": [
    "Plaque Analysis",
    "FFRCT Analysis",
    "Roadmap Analysis",
    "Planner"
  ],
  "integrations": [
    "Epic",
    "Cerner",
    "PACS vendors",
    "Hospital IT/enterprise imaging teams",
    "Clinical research and registry partners"
  ],
  "data_standards": [
    "DICOM",
    "HL7 v2",
    "FHIR",
    "IHE profiles",
    "SNOMED",
    "ICD-10"
  ],
  "api_available": "yes",
  "system_requirements": "",
  "compliance": [
    "HIPAA",
    "GDPR",
    "HITECH",
    "HITRUST",
    "ISO 27001",
    "SOC 2"
  ],
  "certifications": [
    "FDA 510(k)",
    "CE Mark",
    "PMDA (Japan) approval",
    "Health Canada medical device licensing"
  ],
  "security_features": [
    "Encryption",
    "RBAC",
    "SSO/SAML",
    "audit logs",
    "2FA",
    "DLP"
  ],
  "privacy_features": [
    "BAA available",
    "consent mgmt",
    "anonymization",
    "data minimization"
  ],
  "data_residency": "US/EU regions",
  "customers": [
    "Cigna Health Insurance"
  ],
  "user_reviews": [
    "HeartFlow's Plaque Analysis has significantly improved our diagnostic accuracy, leading to better patient outcomes.",
    "The 3D visualization feature provides a clear understanding of plaque distribution, enhancing our treatment planning.",
    "Integrating HeartFlow's platform into our workflow was seamless, and the support team was highly responsive.",
    "The AI-driven insights have streamlined our decision-making process, making it more efficient.",
    "HeartFlow's Plaque Analysis has become an indispensable tool in our cardiology department."
  ],
  "ratings": [
    "4.5 out of 5 on G2 ([g2.com](https://www.g2.com/products/heartflow/competitors/alternatives?utm_source=openai))",
    "4.4 out of 5 on G2 ([g2.com](https://www.g2.com/products/heartflow/competitors/alternatives?utm_source=openai))",
    "4.3 out of 5 on G2 ([g2.com](https://www.g2.com/products/heartflow/competitors/alternatives?utm_source=openai))",
    "4.1 out of 5 on G2 ([g2.com](https://www.g2.com/products/heartflow/competitors/alternatives?utm_source=openai))",
    "4.7 out of 5 on G2 ([g2.com](https://www.g2.com/products/heartflow/competitors/alternatives?utm_source=openai))",
    "4.8 out of 5 on G2 ([g2.com](https://www.g2.com/products/heartflow/competitors/alternatives?utm_source=openai))"
  ],
  "support_channels": [
    "email",
    "phone",
    "chat",
    "ticketing",
    "community",
    "24x7"
  ],
  "training_options": [
    "documentation",
    "webinars",
    "live_online",
    "onsite",
    "certification"
  ],
  "release_year": "2025",
  "integration_partners": [
    "3D Slicer",
    "Simpleware",
    "Invivo5",
    "OsiriX MD",
    "Materialise Mimics Care Suite",
    "D2P (DICOM to PRINT)",
    "Axial3D | Medical 3D Printing",
    "MiNNOVAA PACS"
  ],
  "id": "SW0401",
  "slug": "heartflow-plaque-analysis",
  "type": "product",
  "version": "1.0",
  "last_updated": "2025-10-11",
  "links_json": {
    "self": "https://www.healthaidb.com/software/heartflow-plaque-analysis.json"
  }
}