CAC (gated) Algorithm

by BunkerHill Health  · Based in United States → — Generative AI for clinical reasoning and action.
Cardiology Radiology
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Regulatory Status Disclosed

Overview

The CAC (gated) Algorithm by BunkerHill Health is an FDA-cleared artificial intelligence software designed to automatically detect and quantify coronary artery calcium (CAC) from non-contrast, ECG-gated cardiac CT scans. This tool integrates seamlessly into physicians’ existing workflows, providing crucial calcium segmentation and quantification information to assist in the comprehensive evaluation of coronary artery health. It is specifically intended for use in patients aged 30 years and above.

As part of BunkerHill Health’s broader Carebricks platform, the CAC (gated) Algorithm helps streamline structured reporting for radiologists by pre-populating CAC measurements. This integration enables health systems to design and deploy AI-powered, end-to-end workflows across various specialties, enhancing clinical operations and improving care delivery at scale by turning patient data into actionable insights and automating subsequent steps.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Automatic detection and quantification of coronary artery calcium (CAC)
  • Analysis of non-contrast ECG-gated cardiac CT scans
  • Provides calcium segmentation and quantification
  • Integrates into physicians' standard workflow
  • Pre-populates structured reports for radiologist review and approval
  • Aids in assessing coronary artery health
  • Supports opportunistic detection of cardiovascular disease
  • Part of the broader Carebricks platform for AI-powered workflows
  • FDA-cleared medical device

Use Cases

  • Streamlining structured reporting for CAC measurements on gated CT
  • Prioritizing high CAC gated CTs for review and clinician notification
  • Assessing coronary artery health in patients aged 30 and above
  • Automating clinical operations and improving care delivery at scale
  • Identifying cardiovascular risks and opportunities using AI grounded in guidelines and patient context
  • Automating complex workflows to reduce manual effort for care teams

What Physicians Need to Know

Cardiac CT/MRI Analysis
Automatically detects and quantifies coronary artery calcium (CAC) from non-contrast ECG-gated cardiac CT scans. Provides calcium segmentation and quantification, including Agatston scores, to assist in evaluating coronary artery health and cardiovascular risk.
Coronary Artery Assessment
Primary function is the automated detection and quantification of coronary artery calcium (CAC) from ECG-gated cardiac CT images, aiding physicians in assessing coronary artery health.
Heart Failure Risk Prediction
Assists in assessing overall cardiovascular risk by providing CAC scores, which are a significant indicator. Workflows can be triggered based on elevated CAC to prompt discussions about preventive measures like statin therapy.
Cardiac Monitoring Integration
Integrates into physicians' workflows and interfaces with compatible CT systems. Supports integration with EHRs (via FHIR), PACS/imaging systems, and can facilitate clinician notification and preventive care review based on findings.
AHA/ACC Guideline Alignment
Aids in assessing cardiovascular risk, with workflows designed to align with clinical guidelines for managing elevated CAC, such as prompting statin discussions. FDA-cleared, indicating clinical utility and safety in line with medical practices.
Real-Time Alert Capability
Supports workflows that prioritize clinician notification and preventive care review for high preliminary CAC findings after radiologist sign-off. Can trigger primary-care outreach and appointment scheduling based on detected elevated CAC.
Physician Tip

The CAC (gated) Algorithm is an FDA-cleared AI tool designed to automatically quantify coronary artery calcium from non-contrast ECG-gated cardiac CT scans. Physicians should leverage its precise calcium segmentation and Agatston scores as an adjunctive aid in assessing coronary artery health and overall cardiovascular risk. Integrate these quantitative results with comprehensive patient history and other clinical risk factors to guide personalized preventive care strategies and treatment decisions, such as statin initiation. Remember, the algorithm provides supportive information and is not intended for stand-alone diagnosis.

The CAC (gated) Algorithm is built for seamless integration into existing clinical environments. It offers one-click FHIR-compliant integration with EHRs, connectivity with PACS/imaging systems for result viewing, and can interface with MyChart for patient messaging. Further integrations include laboratory systems, order entry systems, payer systems for prior authorization, clinical registries, SMS gateways, email systems, and telephony/AI voice providers. It also supports integration with partner imaging analysis systems like Cleerly. The output is delivered to existing systems for physician review within their standard workflow.

Details

Category Cardiology AI, Radiology & Imaging AI
Pricing Contact for pricing — Contact BunkerHill Health for detailed pricing information.
DeploymentCloud
Compliance
BAA Available Yes AI-estimated
HIPAA Compliant Yes AI-estimated
FDA Status Yes AI-estimated

The CAC (gated) Algorithm received FDA clearance on September 27, 2024, under K240369. It is classified as a Class II medical device (21 CFR 892.1750, Product Code: JAK) and is intended for estimating the presence and quantity of coronary artery calcium in patients aged 30 years and above from non-contrast ECG-gated cardiac CT images.
Integrations
EHR Not specified
Specialties Cardiology, Radiology

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Press & Coverage

accessdata.fda.gov
510(k) Premarket Notification K240369: CAC (gated) Algorithm
BunkerHill Health's CAC (gated) Algorithm, a software device for estimating coronary artery calcium, received 510(k) clearance from the FDA on September 27, 2024. The device analyzes non-contrast ECG-gated cardiac CT images to output segmentation and quantification of detected calcium for patients aged 30 and above.
2024-09
FDA AI Device Search
FDA AI/ML Device Search - CAC (gated) Algorithm by BunkerHill Health
The FDA's AI/ML Device Search lists BunkerHill Health's CAC (gated) Algorithm as a software medical device that quantifies and categorizes coronary artery calcium from ECG-gated cardiac CT scans using deep learning. It provides physicians with adjunctive information like Agatston scores to assess cardiovascular risk.
2026-02
HealthAidb
CAC (gated) Algorithm - HealthAidb
HealthAidb describes Bunkerhill Health's CAC (gated) Algorithm as an FDA-cleared AI software that automatically detects and quantifies coronary artery calcium from non-contrast ECG-gated cardiac CT scans. It integrates into physician workflows, providing calcium segmentation and quantification to assist in evaluating coronary artery health.
2025-10
Physician Ai Tools
CAC (gated) Algorithm vs Viz HCM - Physician Ai Tools
This article compares BunkerHill Health's CAC (gated) Algorithm with Viz.ai's Viz HCM, highlighting that the CAC (gated) Algorithm focuses on detecting and quantifying coronary artery calcium from CT scans for cardiovascular risk assessment. It notes both tools are FDA-cleared and offer clinical value.
unknown
Innolitics
Definitive Guide to AI/ML SaMD Ground Truthing
Innolitics mentions BunkerHill CAC (gated) Algorithm (K240369) in a guide about AI/ML SaMD ground truthing, specifically in the context of automated CAC scoring from non-contrast cardiac CT producing Agatston, volume, and mass scores.
2025-09
Innolitics
Command Line as a Medical Device (CLaMD)
This article discusses Command Line as a Medical Device (CLaMD) and references BunkerHill Health's CAC (gated) Algorithm (K240369) as an example where the output (quantification and segmentation) can be viewed in a patient report or diagnostic image viewer, implying the software itself does not have its own interactive user interface.
2025-05
FDA.report
BUNKERHILL HEALTH FDA Filings
FDA.report lists the CAC (gated) Algorithm with a decision date of September 27, 2024, under BunkerHill Health's FDA filings.
2024-09
Hardian Health
HaRi u00b7 CAC (gated) Algorithm
Hardian Health's HaRi platform lists the CAC (gated) Algorithm by BunkerHill Health under its regulatory registrations.
unknown

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Frequently Asked Questions

The CAC (gated) Algorithm, specifically Bunkerhill Health's FDA-cleared software, is an AI tool designed to automatically detect and quantify coronary artery calcium (CAC) from non-contrast ECG-gated cardiac CT scans. It assists physicians in evaluating coronary artery health by providing calcium segmentation and quantification information directly within their workflow.
Compliance for healthcare AI, including the CAC (gated) Algorithm, involves adherence to regulations like HIPAA for data privacy and FDA clearance for medical devices. High-risk AI systems that influence diagnosis or treatment require robust internal quality management, logging, traceability, and a 'human-in-the-loop' functionality to ensure safety and accountability.
Pricing models for healthcare AI solutions are evolving, moving from traditional perpetual licensing to more flexible options like subscription-based SaaS with tiered features, or output/task-based usage pricing. Hybrid models that combine flat fees with volume-based charges are also common, reflecting the high development and integration costs.
Physicians should be aware of potential limitations such as algorithmic bias, which can lead to unequal treatment outcomes if the training data lacks diversity. There's also the 'black box' challenge, where a lack of transparency in AI decision-making can hinder trust and understanding. Over-reliance on technology without human oversight can also pose risks to patient safety.
Yes, alternatives exist, including other AI solutions that can detect and quantify CAC from both ECG-gated and non-ECG-gated chest CT scans, such as Nanox.AI's Cardiac Solution. Traditional manual assessment of CT scans also serves as a baseline, though AI aims to improve efficiency and accuracy.
The CAC (gated) Algorithm is designed for seamless integration with existing Picture Archiving and Communication Systems (PACS) and Electronic Medical Record (EMR) systems. It localizes and quantifies coronary artery calcium by analyzing CT images, displaying the results to physicians on-demand within their standard workflow to aid in evaluation.

Compare CAC (gated) Algorithm

VS
CAC (gated) Algorithm vs EchoNext
Cardiology AI Adjacent · 65/100
Both tools are FDA-cleared AI solutions in cardiology, but they differ in their primary focus and input data. Tool A specializes in quantifying coronary artery calcium from cardiac…
VS
CAC (gated) Algorithm vs PMcardio
Cardiology AI Adjacent · 65/100
These tools are adjacent in their focus on cardiology but differ significantly in their diagnostic approach. PMcardio specializes in ECG interpretation for a broad range of cardiac conditions,…
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CAC (gated) Algorithm vs SENSICARDIAC MOBI DIAGNOSTIC HEART MURMUR APPLICATION
Cardiology AI Adjacent · 60/100
These tools are adjacent in the cardiology AI space but serve distinct diagnostic purposes. BunkerHill Health's CAC (gated) Algorithm focuses on quantifying coronary artery calcium from CT scans…
VS
CAC (gated) Algorithm vs SENSICARDIAC
Cardiology AI Adjacent · 65/100
Tool A, the CAC (gated) Algorithm, is designed for assessing coronary artery health by quantifying calcium from CT scans, aiding in the detection of cardiovascular disease. In contrast,…

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Suggest an Edit → | Last Verified: 2026-04-17 | First Added: 2026-04-17
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