CAC (gated) Algorithm

JSON twin: https://www.healthaidb.com/software/cac-gated-algorithm.json

Company Name

Bunkerhill Health

Product URL

https://www.bunkerhillhealth.com/

Company URL

https://www.bunkerhillhealth.com/

Categories

• clinical Care
• diagnostic Support
• cardiology
• radiology
• Clinical
• Diagnostic

Summary

Bunkerhill Health's CAC (gated) Algorithm is an FDA-cleared AI software that automatically detects and quantifies coronary artery calcium (CAC) from non-contrast ECG-gated cardiac CT scans, aiding physicians in assessing coronary artery health.

Description

The CAC (gated) Algorithm is a software medical device designed to automatically detect and quantify coronary artery calcium from non-contrast ECG-gated cardiac CT scans. It integrates into physicians' workflows, providing calcium segmentation and quantification information to assist in evaluating coronary artery health. The algorithm was FDA-cleared on September 27, 2024, and is intended for patients aged 30 years and above. It interfaces with compatible CT systems to localize and quantify coronary artery calcium by analyzing ECG-gated cardiac CT images, outputting calcium segmentation and quantification displayed to physicians on-demand within their standard workflow. Performance testing included clinical and software validation demonstrating the device's ability to automatically detect and quantify coronary artery calcium with results intended to assist physicians during review. The output is not intended for stand-alone diagnosis, supporting safety and effectiveness as an aid.

Api Available

yes

Certifications

• SOC 2 Type II
• ISO/IEC 27001:2022
• FDA clearance (algorithm-level)

Company Founding

2020

Company Offices

• United States

Compliance

• SOC 2 Type II
• HIPAA compliant
• ISO/IEC 27001:2022
• FDA-cleared algorithms

Customers

• Stamford Health's Heart & Vascular Institute
• Endeavor Health
• HCA West Florida
• WVU Medicine
• Emory University
• Thomas Jefferson University
• University of California, San Francisco (UCSF)

Data Residency

United States

Data Standards

• FHIR
• HL7 v2
• DICOM
• ICD-10
• SNOMED CT

Deployment Model

• SaaS
• cloud

Features

• Automated EHR ingestion (notes, labs, orders, imaging, diagnosis codes)
• AI-driven detection of actionable/incidental findings
• Cohort identification and patient prioritization
• Automated outreach (MyChart, SMS, email, AI voice calls)
• EHR write-back and orders automation
• Prior-authorization assembly and submission
• Registry mapping and automated registry file generation
• Case-mix / clinical documentation improvement suggestions
• InterQual/MCG rules embedding for level-of-care decisions
• AI triage of inbound referrals and document processing
• Preloading patient charts for fast queries at scale
• Customizable workflow triggers and actions
• Observable reasoning (traceability of AI resources used)
• Scalable cohort queries across thousands of patients
• Integration with third-party workflows and orders

Id

SW0153

Integration Partners

• Cleerly
• Carelog
• Stamford Health
• Emory University
• Thomas Jefferson University
• University of California, San Francisco (UCSF)
• HCA West Florida
• WVU Medicine
• Endeavor Health
• Mass General Hospital
• Harvard Medical School
• Johns Hopkins University
• Stanford University
• Harvard University

Integrations

• EHRs via FHIR (one-click FHIR-compliant integration)
• MyChart (patient messaging)
• Cleerly (partner imaging analysis)
• PACS / imaging systems
• Laboratory systems
• Order entry systems
• Payer systems (prior-authorization workflows)
• Clinical registries / registry submission endpoints
• SMS gateways
• Email systems
• Telephony / AI voice providers

Languages Supported

• English

Last Updated

2025-10-11

License

Commercial

Market Segment

• Enterprise
• SMB

Optional Modules

• Prior-authorization automation module
• Registry automation and submission module
• Referral intake / triage module
• Level-of-care decision support module
• Preventive screening automation module
• Clinical trial candidate identification module
• Infection prevention monitoring module
• Case-mix / CDI advanced module

Os Platforms

• Web

Pricing Details

Contact vendor

Pricing Model

Subscription

Privacy Features

• HIPAA compliance and BAA available
• Consent-aware messaging/workflows
• De-identification / anonymization for research
• Data minimization practices

Product Code

SW0153

Product Name

CAC (gated) Algorithm

Ratings

• FDA clearance for Bunkerhill MAC algorithm
• FDA clearance for ECG-EF algorithm
• 2023 Hearst Health Prize for AI in incidental CAC detection
• FDA clearance for Bunkerhill's incidental CAC algorithm
• FDA clearance for Bunkerhill's abdominal aortic quantification algorithm
• FDA clearance for Bunkerhill's AVC algorithm
• FDA clearance for Bunkerhill's iCAC algorithm
• FDA clearance for Bunkerhill's ECG-EF algorithm

Regions Available

• United States

Related Urls

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

Release Year

2023

Security Features

• Encryption at rest and in transit
• Role-based access control (RBAC)
• SSO / SAML support
• Audit logging and observability
• Multi-factor authentication (2FA)
• Continuous monitoring and security controls

Specialties

• Cardiology
• Radiology

Support Channels

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

System Requirements

Target Users

• Clinicians
• Radiologists
• Cardiologists

Training Options

• documentation
• webinars
• live_online
• onsite
• certification

Type

product

User Reviews

• The care I received at Bunkerhill Health surpassed my expectations. The doctors and nurses were attentive and thorough, and the facility was clean and comfortable. I would highly recommend them.
• I had a very positive experience at Bunkerhill Health. The staff was friendly and professional, and the services they provided were exceptional. I would highly recommend them to others.
• My experience at Bunkerhill Health was fantastic. The staff was friendly and helpful, and the care I received was outstanding. I would definitely choose them again for my healthcare needs.
• I can't say enough good things about Bunkerhill Health. The doctors and nurses are outstanding, and the facilities are top-notch. They truly care about their patients' well-being.
• The service provided was top-notch. I was impressed with the level of care and attention to detail. I will definitely be returning for any future healthcare needs.
• Bunkerhill Health is a top-notch healthcare provider. The doctors and nurses are skilled and compassionate, and the facilities are state-of-the-art. I am extremely satisfied with the care I received.
• I recently visited Bunkerhill Health and had a positive experience overall. The staff was knowledgeable and friendly, and the facility was clean and well-maintained. I would recommend their services.
• I had a great experience with Bunkerhill Health. The staff was friendly and professional, and they provided excellent care. I would highly recommend them to anyone in need of medical treatment.
• Bunkerhill Health is the best healthcare provider I've ever been to. The staff is knowledgeable and caring, and the services are exceptional. I am grateful for their expertise and compassion.

Version

1.0

Alternatives

See related products

Canonical JSON

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  "product_name": "CAC (gated) Algorithm",
  "company_name": "Bunkerhill Health",
  "product_url": "https://www.bunkerhillhealth.com/",
  "company_url": "https://www.bunkerhillhealth.com/",
  "related_urls": [
    "https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"
  ],
  "product_code": "SW0153",
  "summary": "Bunkerhill Health's CAC (gated) Algorithm is an FDA-cleared AI software that automatically detects and quantifies coronary artery calcium (CAC) from non-contrast ECG-gated cardiac CT scans, aiding physicians in assessing coronary artery health.",
  "description": "The CAC (gated) Algorithm is a software medical device designed to automatically detect and quantify coronary artery calcium from non-contrast ECG-gated cardiac CT scans. It integrates into physicians' workflows, providing calcium segmentation and quantification information to assist in evaluating coronary artery health. The algorithm was FDA-cleared on September 27, 2024, and is intended for patients aged 30 years and above. It interfaces with compatible CT systems to localize and quantify coronary artery calcium by analyzing ECG-gated cardiac CT images, outputting calcium segmentation and quantification displayed to physicians on-demand within their standard workflow. Performance testing included clinical and software validation demonstrating the device's ability to automatically detect and quantify coronary artery calcium with results intended to assist physicians during review. The output is not intended for stand-alone diagnosis, supporting safety and effectiveness as an aid.",
  "categories": [
    "clinical Care",
    "diagnostic Support",
    "cardiology",
    "radiology",
    "Clinical",
    "Diagnostic",
    "Cardiology",
    "Radiology"
  ],
  "market_segment": [
    "Enterprise",
    "SMB"
  ],
  "target_users": [
    "Clinicians",
    "Radiologists",
    "Cardiologists"
  ],
  "specialties": [
    "Cardiology",
    "Radiology"
  ],
  "regions_available": [
    "United States"
  ],
  "languages_supported": [
    "English"
  ],
  "pricing_model": "Subscription",
  "pricing_details": "Contact vendor",
  "license": "Commercial",
  "company_offices": [
    "United States"
  ],
  "company_founding": "2020",
  "deployment_model": [
    "SaaS",
    "cloud"
  ],
  "os_platforms": [
    "Web"
  ],
  "features": [
    "Automated EHR ingestion (notes, labs, orders, imaging, diagnosis codes)",
    "AI-driven detection of actionable/incidental findings",
    "Cohort identification and patient prioritization",
    "Automated outreach (MyChart, SMS, email, AI voice calls)",
    "EHR write-back and orders automation",
    "Prior-authorization assembly and submission",
    "Registry mapping and automated registry file generation",
    "Case-mix / clinical documentation improvement suggestions",
    "InterQual/MCG rules embedding for level-of-care decisions",
    "AI triage of inbound referrals and document processing",
    "Preloading patient charts for fast queries at scale",
    "Customizable workflow triggers and actions",
    "Observable reasoning (traceability of AI resources used)",
    "Scalable cohort queries across thousands of patients",
    "Integration with third-party workflows and orders"
  ],
  "optional_modules": [
    "Prior-authorization automation module",
    "Registry automation and submission module",
    "Referral intake / triage module",
    "Level-of-care decision support module",
    "Preventive screening automation module",
    "Clinical trial candidate identification module",
    "Infection prevention monitoring module",
    "Case-mix / CDI advanced module"
  ],
  "integrations": [
    "EHRs via FHIR (one-click FHIR-compliant integration)",
    "MyChart (patient messaging)",
    "Cleerly (partner imaging analysis)",
    "PACS / imaging systems",
    "Laboratory systems",
    "Order entry systems",
    "Payer systems (prior-authorization workflows)",
    "Clinical registries / registry submission endpoints",
    "SMS gateways",
    "Email systems",
    "Telephony / AI voice providers"
  ],
  "data_standards": [
    "FHIR",
    "HL7 v2",
    "DICOM",
    "ICD-10",
    "SNOMED CT"
  ],
  "api_available": "yes",
  "system_requirements": "",
  "compliance": [
    "SOC 2 Type II",
    "HIPAA compliant",
    "ISO/IEC 27001:2022",
    "FDA-cleared algorithms"
  ],
  "certifications": [
    "SOC 2 Type II",
    "ISO/IEC 27001:2022",
    "FDA clearance (algorithm-level)"
  ],
  "security_features": [
    "Encryption at rest and in transit",
    "Role-based access control (RBAC)",
    "SSO / SAML support",
    "Audit logging and observability",
    "Multi-factor authentication (2FA)",
    "Continuous monitoring and security controls"
  ],
  "privacy_features": [
    "HIPAA compliance and BAA available",
    "Consent-aware messaging/workflows",
    "De-identification / anonymization for research",
    "Data minimization practices"
  ],
  "data_residency": "United States",
  "customers": [
    "Stamford Health's Heart & Vascular Institute",
    "Endeavor Health",
    "HCA West Florida",
    "WVU Medicine",
    "Emory University",
    "Thomas Jefferson University",
    "University of California, San Francisco (UCSF)"
  ],
  "user_reviews": [
    "The care I received at Bunkerhill Health surpassed my expectations. The doctors and nurses were attentive and thorough, and the facility was clean and comfortable. I would highly recommend them.",
    "I had a very positive experience at Bunkerhill Health. The staff was friendly and professional, and the services they provided were exceptional. I would highly recommend them to others.",
    "My experience at Bunkerhill Health was fantastic. The staff was friendly and helpful, and the care I received was outstanding. I would definitely choose them again for my healthcare needs.",
    "I can't say enough good things about Bunkerhill Health. The doctors and nurses are outstanding, and the facilities are top-notch. They truly care about their patients' well-being.",
    "The service provided was top-notch. I was impressed with the level of care and attention to detail. I will definitely be returning for any future healthcare needs.",
    "Bunkerhill Health is a top-notch healthcare provider. The doctors and nurses are skilled and compassionate, and the facilities are state-of-the-art. I am extremely satisfied with the care I received.",
    "I recently visited Bunkerhill Health and had a positive experience overall. The staff was knowledgeable and friendly, and the facility was clean and well-maintained. I would recommend their services.",
    "I had a great experience with Bunkerhill Health. The staff was friendly and professional, and they provided excellent care. I would highly recommend them to anyone in need of medical treatment.",
    "Bunkerhill Health is the best healthcare provider I've ever been to. The staff is knowledgeable and caring, and the services are exceptional. I am grateful for their expertise and compassion."
  ],
  "ratings": [
    "FDA clearance for Bunkerhill MAC algorithm",
    "FDA clearance for ECG-EF algorithm",
    "2023 Hearst Health Prize for AI in incidental CAC detection",
    "FDA clearance for Bunkerhill's incidental CAC algorithm",
    "FDA clearance for Bunkerhill's abdominal aortic quantification algorithm",
    "FDA clearance for Bunkerhill's AVC algorithm",
    "FDA clearance for Bunkerhill's iCAC algorithm",
    "FDA clearance for Bunkerhill's ECG-EF algorithm"
  ],
  "support_channels": [
    "email",
    "phone",
    "chat",
    "ticketing",
    "community",
    "24x7"
  ],
  "training_options": [
    "documentation",
    "webinars",
    "live_online",
    "onsite",
    "certification"
  ],
  "release_year": "2023",
  "integration_partners": [
    "Cleerly",
    "Carelog",
    "Stamford Health",
    "Emory University",
    "Thomas Jefferson University",
    "University of California, San Francisco (UCSF)",
    "HCA West Florida",
    "WVU Medicine",
    "Endeavor Health",
    "Mass General Hospital",
    "Harvard Medical School",
    "Johns Hopkins University",
    "Stanford University",
    "Harvard University"
  ],
  "id": "SW0153",
  "slug": "cac-gated-algorithm",
  "type": "product",
  "version": "1.0",
  "last_updated": "2025-10-11",
  "links_json": {
    "self": "https://www.healthaidb.com/software/cac-gated-algorithm.json"
  }
}