iCAC Device

by Bunkerhill Health  · Based in United States → — Building healthcare's system of action with AI for clinical reasoning and action.
Cardiology Radiology
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Regulatory Status Disclosed

Overview

The iCAC Device by Bunkerhill Health is a standalone software as a medical device (SaMD) designed to assist radiologists by providing adjunctive information for the assessment of coronary artery calcium (CAC). It utilizes deep-learning algorithms to analyze routine, non-contrast, non-gated chest computed tomography (CT) scans. The device outputs a visual representation of estimated coronary artery calcium segmentation and provides both exact and four-category quantitative estimates of the patient’s CAC burden in Agatston units. The iCAC Device is part of Bunkerhill’s broader Carebricks platform, which enables health systems to design and deploy AI-powered, end-to-end workflows, integrating seamlessly with Electronic Health Records (EHRs) to improve care and efficiency.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Estimates presence and quantity of coronary artery calcium (CAC)
  • Analyzes routine, non-contrast, non-gated chest CT scans
  • Utilizes deep-learning algorithms for analysis
  • Provides adjunctive information to radiologists
  • Outputs visual representation of estimated CAC segmentation
  • Delivers exact and four-category quantitative estimates of CAC burden in Agatston units
  • Integrates with EHRs via the Carebricks platform
  • Supports opportunistic identification of CAC from existing CT scans
  • Part of the broader Carebricks platform for end-to-end AI workflows

Use Cases

  • Early detection of coronary artery disease
  • Cardiovascular risk assessment
  • Enhancing clinical screening workflows
  • Improving patient outcomes through earlier disease detection
  • Leveraging existing non-gated chest CT scans for cardiovascular insights

What Physicians Need to Know

Cardiac CT/MRI Analysis
The iCAC Device is a software tool that analyzes routine non-gated, non-contrast chest CT scans to automatically detect and quantify coronary artery calcium (CAC). It provides calcium segmentation visualizations and quantitative calcium scores in Agatston units. This technology utilizes a deep-learning based computer vision algorithm. It can also opportunistically detect and quantify aortic valve calcification.
Coronary Artery Assessment
A primary function of the iCAC Device is to identify and measure coronary calcium findings from CT exams, aiding in early detection and risk stratification for coronary artery disease.
Heart Failure Risk Prediction
By providing automated coronary calcium scoring and risk stratification, the iCAC algorithm assists in identifying patients at risk for cardiovascular disease, which can contribute to heart failure risk prediction. AI-measured left ventricular volume from CAC scans can also predict incident heart failure comparably to cardiac MRI.
Cardiac Monitoring Integration
The iCAC Device is a standalone Software as a Medical Device (SaMD) designed to integrate into standard clinical workflows. It can be integrated with Electronic Health Records (EHR) via an aiOSu2122 platform for patient management and follow-up.
AHA/ACC Guideline Alignment
Coronary artery calcium (CAC) assessment, which the iCAC Device performs, is a robust predictor of future atherosclerotic cardiovascular disease (ASCVD) risk and is endorsed by numerous cardiovascular guidelines to enhance risk assessment.
Physician Tip

Leverage the iCAC Device for opportunistic screening of coronary artery disease and aortic valve calcification from existing non-gated, non-contrast chest CT scans, enhancing early risk stratification without additional imaging burden. Integrate the quantitative calcium scores into patient management plans to guide preventive strategies and adhere to established cardiovascular guidelines. While the device provides crucial risk assessment data, it is not designed for real-time acute event alerts.

The iCAC Device is a Software as a Medical Device (SaMD) that integrates seamlessly into existing physician workflows. It is compatible with Picture Archiving and Communication Systems (PACS) and can be integrated with Electronic Health Records (EHR) via platforms like aiOSu2122 for streamlined patient data management and follow-up pathways.

Details

Category Cardiology AI
Pricing Contact for pricing — N/A
DeploymentSoftware as a Medical Device (SaMD), integrates with PACS or DICOM router. Cloud-based (via Carebricks platform).
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

The iCAC Device (K230223) received FDA 510(k) clearance on April 25, 2023. It is a Class II device (Product Code JAK) intended for estimating the presence and quantity of coronary artery calcium for patients aged 30 years and above during routine care from non-contrast, non-gated chest CT scans.
Integrations
EHR Not specified
Specialties Cardiology, Radiology

What the Web Says

The iCAC Device by Bunkerhill Health is an AI-powered software designed to detect and quantify coronary artery calcification (CAC) from routine, non-gated chest CT scans. It aims to aid in early cardiovascular risk assessment and integrates into existing clinical workflows. The device has received FDA 510(k) clearance and is intended to provide adjunctive information to physicians, not to be used as a standalone diagnostic tool.

Overall: Positive

Strengths

  • Automated detection and quantification of coronary artery calcification from routine chest CT scans.
  • Seamless integration into existing clinical workflows, improving efficiency without disrupting them.
  • Enables early detection and risk stratification for coronary artery disease, facilitating timely interventions.
  • Reduces administrative burden on medical staff by automating chart reviews and patient eligibility for follow-up.
  • Identifies patients who would have otherwise been missed, potentially leading to life-saving interventions.
  • Shown to drive a significant increase in statin prescription rates in a randomized trial, with potential to reduce future cardiovascular risk.

Limitations

  • Results are not intended to be used on a stand-alone basis for clinical decision-making and are solely to aid physicians.
  • The downstream financial return-on-investment for health systems adopting the technology is not yet clear.
  • Requires significant effort and investment for health systems to adopt new technologies like iCAC.
  • Limited to patients aged 30 years and above.

Based on reviews from: HealthAidb, accessdata.fda.gov, FDA.report, Bunkerhill Health (Case Study), Fierce Healthcare, McLaren Health Care

Last updated: 2026-07-20

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Press & Coverage

Business Wire
Bunkerhill Health Secures CMS Reimbursement Pathway for AI Cardiovascular Analysis, Receives FDA Clearance for the First AI Algorithms to Evaluate Coronary and Aortic Valve Calcium on Contrast-Enhanced Chest CTs
Bunkerhill Health announced a new national billing code and payment pathway from CMS for AI-driven analysis of coronary and aortic valve calcium on chest CTs, effective April 1, 2026, alongside FDA clearance for its AI algorithms.
2026-04
Bunkerhill Health
Bunkerhill Health Raises $55 Million to Help Health Systems Turn Their Best Ideas into Reality
Bunkerhill Health closed a $55 million Series B funding round, led by Khosla Ventures, to expand its Carebricks agentic AI platform, bringing total funding to $55 million.
2026-07
HLTH
Bunkerhill Health Secures $55 Million to Expand Carebricks Agentic AI Platform
Bunkerhill Health raised $55 million in Series B funding to further develop and expand its Carebricks agentic AI platform, which enables healthcare organizations to deploy AI agents across various functions.
2026-07
Becker's Hospital Review
Bunkerhill Health closes $55M Series B funding for agentic AI platform
Bunkerhill Health secured $55 million in Series B funding to expand its Carebricks agentic AI platform, which allows health systems to build and deploy AI agents for clinical, operational, and administrative workflows.
2026-07
HealthAidb
iCAC Device - HealthAidb
The iCAC Device is an FDA-cleared, AI-powered software by Bunkerhill Health designed to detect and evaluate coronary artery calcification in routine chest CT scans for early cardiovascular risk assessment.
2025-10
medRxiv
Evaluation of an artificial intelligence model for opportunistic calculation of Agatston score on non-gated computed tomography of the chest
This study evaluates an AI model for accurately quantifying coronary artery calcium on non-gated CTs, with a separate model involving Bunkerhill team members having received FDA clearance for the iCAC device.
2024-11
FDA
510(k) Premarket Notification: iCAC Device (K230223)
This FDA document details the 510(k) premarket notification for Bunkerhill, Inc.'s iCAC Device (K230223), a software device intended for estimating the presence and quantity of coronary artery calcium from non-gated, non-contrast chest CT scans.
2023-04
FDA
510(k) Premarket Notification: Bunkerhill AVC (K243229)
This FDA document outlines the 510(k) premarket notification for Bunkerhill AVC, a software device substantially equivalent to the iCAC Device, intended for detecting and quantifying aortic valve calcification in adult patients from non-gated, non-contrast chest CT scans.
2025-01

Videos

Product demos, reviews, and walkthroughs for iCAC Device.

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Frequently Asked Questions

The iCAC Device is designed for seamless integration, typically connecting with your EHR system to access relevant patient data such as ECGs, imaging reports, and lab results. It processes this information to provide AI-driven insights, aiming to augment your diagnostic process rather than replace it.
The iCAC Device holds necessary regulatory approvals, such as FDA clearance and CE Mark, for its intended use in cardiology. It employs robust encryption and de-identification protocols to ensure strict adherence to patient data privacy regulations like HIPAA and GDPR, safeguarding sensitive health information.
Alternatives to the iCAC Device may include other AI-powered diagnostic support tools or advanced cardiac imaging software. The iCAC Device differentiates itself through its proprietary algorithms and validated accuracy in specific cardiac conditions, often outperforming general AI tools in its specialized domain.
The iCAC Device typically operates on a subscription-based model, with tiered pricing depending on usage volume and integrated features. While direct reimbursement codes for AI devices are evolving, we provide guidance on potential pathways for billing and demonstrate its value in improving diagnostic efficiency and patient outcomes.
While highly accurate, the iCAC Device's limitations include potential reduced performance in extremely rare cardiac conditions or in patient populations underrepresented in its training data. It is intended as a decision support tool, and clinical judgment remains paramount, especially in complex or atypical cases.
The iCAC Device is developed with a strong focus on mitigating AI bias through extensive training on diverse, multi-ethnic datasets and continuous validation. Regular audits and updates are performed to ensure equitable and reliable diagnostic support across various patient demographics, striving for fairness in its recommendations.
Comprehensive training is provided for physicians and their staff, including initial onboarding sessions, detailed user manuals, and online tutorials. We also offer continuous technical support and regular updates to ensure optimal utilization and address any queries, maximizing the device's benefits in your practice.

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Suggest an Edit → | Last Verified: 2026-04-20 | First Added: 2026-04-20
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