CaRi-Plaque

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

Company Name

Caristo Diagnostics

Product URL

https://www.caristo.com/coronary-plaque-analysis/

Company URL

https://www.caristo.com

Categories

• clinical Care
• imaging Software
• cardiology
• ai Clinical Documentation Integrity
• clinical Decision Support
• healthcare It
• software As A Service
• medical Device
• regulatory Compliance
• cloud-based Solutions
• Clinical
• Diagnostic Imaging
• Artificial Intelligence
• Medical Imaging
• Health It
• Fda-cleared
• Cloud-based

Summary

CaRi-Plaque is an AI-assisted image analysis application developed by Caristo Diagnostics to noninvasively assess coronary artery disease from routine CT angiography scans, determining plaque presence, extent, and severity.

Description

CaRi-Plaque utilizes artificial intelligence to analyze coronary CT angiography (CCTA) scans, providing detailed assessments of coronary plaque characteristics and luminal stenosis. The software delivers comprehensive reports that include metrics such as maximum stenosis, total plaque volume, and plaque burden, aiding clinicians in the early detection and management of coronary artery disease. It has been validated against independent clinical experts, demonstrating high accuracy in plaque characterization. The technology is FDA-cleared and is available for use in hospitals, health systems, and longevity clinics. Clinics using CaRi-Plaque can seamlessly adopt Caristo’s CaRi-Heart® when cleared by FDA, enabling the analysis of both plaque and coronary inflammation, providing an unprecedented, full-spectrum view of heart disease before symptoms arise.

Api Available

unknown

Certifications

• FDA 510(k) clearance
• CE Mark
• UKCA Mark
• ISO 13485
• ISO 9001

Company Founding

2018

Company Offices

• United States
• United Kingdom
• European Union
• Australia

Compliance

• FDA 510(k) clearance
• CE Mark
• UKCA Mark
• HIPAA
• GDPR
• HITECH
• SOC 2
• ISO 27001

Customers

Data Residency

US/EU regions

Data Standards

• DICOM

Deployment Model

• SaaS

Features

• AI-assisted coronary plaque detection
• Quantification of plaque type, volume, and severity
• Non-invasive analysis of coronary anatomy and pathology
• Integration with routine coronary CT angiography (CCTA) scans
• Generation of comprehensive plaque analysis reports
• Secure and anonymized data transfer
• Cloud-based processing with de-identified data
• DICOM-conformant and PDF report delivery

Id

SW0093

Integration Partners

Integrations

• CCTA scanners
• PACS systems

Languages Supported

• English

Last Updated

2025-10-11

License

Commercial

Market Segment

• Enterprise
• SMB
• Consumer

Optional Modules

• CaRi-Heart® for coronary inflammation analysis

Os Platforms

• Web

Pricing Details

Contact vendor for pricing information.

Pricing Model

Subscription

Privacy Features

• BAA available
• Consent management
• Anonymization
• Data minimization

Product Code

SW0093

Product Name

CaRi-Plaque

Ratings

Regions Available

• United States
• United Kingdom
• European Union
• Australia

Related Urls

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

Release Year

Security Features

• Encryption
• RBAC
• Audit logs
• 2FA

Specialties

• Cardiology
• Radiology
• Preventive Medicine
• Medical Imaging
• Health Informatics

Support Channels

System Requirements

Target Users

• Clinicians
• Cardiologists
• Radiologists
• Healthcare Administrators
• Medical Researchers

Training Options

Type

product

User Reviews

Version

1.0

Alternatives

See related products

Canonical JSON

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  "product_name": "CaRi-Plaque",
  "company_name": "Caristo Diagnostics",
  "product_url": "https://www.caristo.com/coronary-plaque-analysis/",
  "company_url": "https://www.caristo.com",
  "related_urls": [
    "https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"
  ],
  "product_code": "SW0093",
  "summary": "CaRi-Plaque is an AI-assisted image analysis application developed by Caristo Diagnostics to noninvasively assess coronary artery disease from routine CT angiography scans, determining plaque presence, extent, and severity.",
  "description": "CaRi-Plaque utilizes artificial intelligence to analyze coronary CT angiography (CCTA) scans, providing detailed assessments of coronary plaque characteristics and luminal stenosis. The software delivers comprehensive reports that include metrics such as maximum stenosis, total plaque volume, and plaque burden, aiding clinicians in the early detection and management of coronary artery disease. It has been validated against independent clinical experts, demonstrating high accuracy in plaque characterization. The technology is FDA-cleared and is available for use in hospitals, health systems, and longevity clinics. Clinics using CaRi-Plaque can seamlessly adopt Caristo’s CaRi-Heart® when cleared by FDA, enabling the analysis of both plaque and coronary inflammation, providing an unprecedented, full-spectrum view of heart disease before symptoms arise.",
  "categories": [
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    "imaging Software",
    "cardiology",
    "ai Clinical Documentation Integrity",
    "clinical Decision Support",
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    "software As A Service",
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    "regulatory Compliance",
    "cloud-based Solutions",
    "Clinical",
    "Diagnostic Imaging",
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    "Artificial Intelligence",
    "Medical Imaging",
    "Health It",
    "Software As A Service",
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    "Fda-cleared",
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  "market_segment": [
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    "SMB",
    "Consumer"
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  "target_users": [
    "Clinicians",
    "Cardiologists",
    "Radiologists",
    "Healthcare Administrators",
    "Medical Researchers"
  ],
  "specialties": [
    "Cardiology",
    "Radiology",
    "Preventive Medicine",
    "Medical Imaging",
    "Health Informatics"
  ],
  "regions_available": [
    "United States",
    "United Kingdom",
    "European Union",
    "Australia"
  ],
  "languages_supported": [
    "English"
  ],
  "pricing_model": "Subscription",
  "pricing_details": "Contact vendor for pricing information.",
  "license": "Commercial",
  "company_offices": [
    "United States",
    "United Kingdom",
    "European Union",
    "Australia"
  ],
  "company_founding": "2018",
  "deployment_model": [
    "SaaS"
  ],
  "os_platforms": [
    "Web"
  ],
  "features": [
    "AI-assisted coronary plaque detection",
    "Quantification of plaque type, volume, and severity",
    "Non-invasive analysis of coronary anatomy and pathology",
    "Integration with routine coronary CT angiography (CCTA) scans",
    "Generation of comprehensive plaque analysis reports",
    "Secure and anonymized data transfer",
    "Cloud-based processing with de-identified data",
    "DICOM-conformant and PDF report delivery"
  ],
  "optional_modules": [
    "CaRi-Heart® for coronary inflammation analysis"
  ],
  "integrations": [
    "CCTA scanners",
    "PACS systems"
  ],
  "data_standards": [
    "DICOM"
  ],
  "api_available": "unknown",
  "system_requirements": "",
  "compliance": [
    "FDA 510(k) clearance",
    "CE Mark",
    "UKCA Mark",
    "HIPAA",
    "GDPR",
    "HITECH",
    "SOC 2",
    "ISO 27001"
  ],
  "certifications": [
    "FDA 510(k) clearance",
    "CE Mark",
    "UKCA Mark",
    "ISO 13485",
    "ISO 9001"
  ],
  "security_features": [
    "Encryption",
    "RBAC",
    "Audit logs",
    "2FA"
  ],
  "privacy_features": [
    "BAA available",
    "Consent management",
    "Anonymization",
    "Data minimization"
  ],
  "data_residency": "US/EU regions",
  "customers": [],
  "user_reviews": [],
  "ratings": [],
  "support_channels": [],
  "training_options": [],
  "release_year": "",
  "integration_partners": [],
  "id": "SW0093",
  "slug": "cari-plaque",
  "type": "product",
  "version": "1.0",
  "last_updated": "2025-10-11",
  "links_json": {
    "self": "https://www.healthaidb.com/software/cari-plaque.json"
  }
}