cvi42 Coronary Plaque

by Circle Cardiovascular Imaging  · Based in Canada → — See More Than Stenosis. Quantify Risk. Personalize Care.
Cardiology Radiology

Contact vendor for pricing details.
Regulatory Status Disclosed

Overview

The cvi42 | Plaque solution by Circle Cardiovascular Imaging is an AI-enabled, on-premise software application designed for comprehensive coronary plaque analysis directly from Cardiac CT Angiography (CCTA) scans. It empowers cardiac imaging teams to quantify atherosclerotic burden, delivering precise measurements of plaque volume, burden, composition (calcified, non-calcified, and low attenuation), and distribution. The tool integrates seamlessly into existing CT workflows, providing automated coronary lumen and wall segmentation for rapid and reproducible plaque quantification. Beyond stenosis assessment, cvi42 | Plaque identifies high-risk features like low-attenuation plaques and remodeling index, offering superior prognostic information. It provides full user control with manual adjustment capabilities for annotations and supports lesion-level occlusion marking for revascularization planning. This FDA-cleared solution enhances diagnostic workflows, improves risk stratification, and informs more personalized patient care.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • AI-enabled coronary plaque quantification
  • Automated coronary lumen and wall segmentation
  • Per-lesion and per-vessel plaque analysis
  • Quantification of calcified, non-calcified, and low attenuation plaque
  • Remodeling index calculation
  • Integrated into CT workflow
  • On-premise solution
  • Full user control with manual adjustments
  • Enhanced coronary reporting
  • Compatible with all major vendor systems

Use Cases

  • Comprehensive coronary plaque analysis
  • Risk stratification for coronary artery disease
  • Personalized treatment planning
  • Diagnostic workflows enhancement
  • Evaluation of atherosclerotic burden
  • Revascularization planning

What Physicians Need to Know

Cardiac CT/MRI Analysis
cvi42 | Plaque is an AI-enabled solution specifically designed for comprehensive coronary plaque analysis directly from Coronary CT Angiography (CCTA) scans. It quantifies total, calcified, non-calcified, and low-attenuation plaque. The tool performs automated coronary lumen and wall segmentation, per-lesion and per-vessel analysis, and remodeling index calculation. While part of the broader cvi42 platform that handles cardiac MR, this specific module focuses on CT analysis.
Heart Failure Risk Prediction
The detailed plaque analysis provided by cvi42 | Plaque supports more precise risk stratification and aids in informing personalized treatment plans. It offers superior prognostic information compared to traditional stenosis-based or risk-factor assessments. The tool identifies high-risk features such as low-attenuation plaques (<60HU) and remodeling index, which independently predict adverse cardiac events.
Coronary Artery Assessment
This tool's core function is AI-enabled, on-premise quantification of atherosclerotic burden from CCTA. It delivers precise measurements of plaque volume, burden, composition (total, calcified, non-calcified, and low-attenuation), and distribution. Key features include automated coronary lumen and wall segmentation, per-lesion and per-vessel analysis, and remodeling index calculation to identify high-risk plaques beyond stenosis severity. It also integrates CAD-RADS classification for standardized reporting.
AHA/ACC Guideline Alignment
The tool enables guideline-consistent plaque reporting. The American College of Cardiology (ACC) has issued a scientific statement confirming that quantitative plaque analysis is a powerful tool for enhancing risk assessment and guiding preventive therapies. The integrated CAD-RADS classification supports standardized reporting and facilitates communication across the care team.
Physician Tip

Leverage the AI-enabled quantification of total, calcified, non-calcified, and low-attenuation plaque from CCTA for precise risk stratification and personalized treatment plans. Utilize the on-premise solution to maintain control over patient data, improve study processing times, and enhance workflow efficiency, avoiding the need for external reading services. Integrate the detailed plaque analysis, including remodeling index and low-attenuation plaque assessment, to identify high-risk plaques beyond traditional stenosis assessment, as this offers superior prognostic information. Capitalize on the new Category I CPT code (75577) for AI-enabled coronary plaque analysis, which facilitates reimbursement and recognizes plaque quantification as standard clinical care. Use the integrated CAD-RADS classification for standardized reporting and improved communication within the care team.

cvi42 | Plaque is designed to integrate seamlessly into existing CT workflows and is compatible with all major vendor systems. It is available as part of the broader cvi42 platform, which also supports cardiac MR. The platform offers simplified integrations with PACS/VNA, EMR, DICOM, HL7, and reporting interfaces. As an on-premise solution, it keeps image data, AI processing, and reporting within the institution's environment, enhancing data control and security.

Details

Category Cardiology AI, Radiology & Imaging AI
Pricing Contact vendor for pricing details. — Subscription-based; scales across CT and MR service lines; new CPT codes enable reimbursement.
DeploymentOn-premise
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

Received 510(k) clearance from the U.S. Food and Drug Administration (FDA) on October 27, 2025, for the cvi42 Coronary Plaque Software Application (K251027). It is classified as an Automated Radiological Image Processing Software (Class II - Special Controls, product code QIH).

Integrations
EHR Not specified
Specialties Cardiology, Radiology

What the Web Says

cvi42 Coronary Plaque is an AI-enabled, on-premise software solution designed for comprehensive coronary plaque analysis from CT angiography (CCTA) scans. It has received FDA 510(k) clearance and is available for clinical use in the United States. Physicians and healthcare IT professionals highlight its ability to provide fast, accurate, and reproducible quantification of total, calcified, and non-calcified plaque, supporting precise risk stratification and personalized treatment plans. The software integrates into existing CT workflows and is compatible with major vendor systems, offering an in-house solution that enhances diagnostic workflows and patient care.

Overall: Positive

Strengths

  • Provides fast, accurate, and reproducible quantification of total, calcified, and non-calcified plaque.
  • Supports precise risk stratification and personalized treatment plans.
  • On-premise solution, allowing clinicians greater control over data, improved study processing times, and enhanced workflow efficiency without sending patient data to external services.
  • Integrates seamlessly into existing CT workflows and is compatible with all major vendor systems.
  • New Category I CPT code (75577) for AI-enabled coronary plaque analysis, effective January 1, 2026, facilitates national pricing and physician reimbursement, with coverage from Medicare and major commercial payers.
  • Automated coronary lumen and wall segmentation, per-lesion and per-vessel analysis, and remodeling index calculation help identify high-risk plaques.

Limitations

  • Potential for bundling and denials with new CPT codes, requiring refined billing practices.
  • Multiple Procedure Payment Reduction (MPPR) can cut reimbursement for subsequent imaging codes in the same session.
  • Productivity adjustments in Physician Fee Schedule (PFS) may erode physician office rates.
  • Requires qualified medical professionals experienced in examining cardiovascular CT images for proper use.
  • Some Reddit discussions indicate that coronary calcium scores (a related but distinct concept) are not universally embraced or understood, with some physicians questioning their value for certain patient populations.

Based on reviews from: DAIC, HMP Global Learning Network, Circle Cardiovascular Imaging, Capterra, Innolitics, SourceForge, Reddit

Last updated: 2026-07-20

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Press & Coverage

Circle CVI
Circle CVI Announces FDA Clearance for cvi42 | Plaque for Coronary Artery Disease Evaluation
Circle Cardiovascular Imaging Inc. announced that its cvi42 | Plaque solution received 510(k) clearance from the U.S. FDA, making the AI-enabled solution for comprehensive coronary plaque analysis available for clinical use in the United States.
2025-10
Circle CVI
Expanded Insurance Coverage Validates Circle's AI Approach to Coronary Plaque Evaluation
Circle CVI announced that clinical practices using its FDA 510(k)-cleared cvi42 with AI-enabled plaque analysis solution are well-positioned for reimbursement under the new permanent Category I CPT code 75577, effective January 1, 2026.
2026-01
Circle CVI
Circle Cardiovascular Imaging Expands cvi42 Platform with Advanced Vascular CT Capabilities
Circle Cardiovascular Imaging announced the expansion of its cvi42 platform to include advanced Vascular CT analysis, integrating Astute Imaging's AI-driven vascular analysis technology to enable comprehensive cardiovascular workflows.
2026-03
Innolitics
2025 Year in Review: Cardiology AI/ML SaMD 510(k) Clearances - Innolitics
This article provides a comprehensive analysis of 2025 cardiology AI/ML clearances, market trends, capital events, and regulatory insights, listing Circle Cardiovascular Imaging Inc.'s cvi42 Coronary Plaque Software Application among the cleared devices.
2026-01
FDA
cvi42 Coronary Plaque Software Application (K251027)
This FDA 510(k) Premarket Notification document details the cvi42 Coronary Plaque Software Application, its intended use for viewing, post-processing, and evaluation of cardiovascular CT images, and its semi-automated machine learning algorithms for an adult population.
2025-10
AuntMinnie
Circle CVI expands cvi42 platform with vascular CT analysis
Circle Cardiovascular Imaging has expanded its cvi42 cardiovascular imaging platform to include vascular CT analysis through a collaboration with Astute Imaging, integrating AI-driven vascular analysis technology.
2026-03
PR Newswire
Circle Cardiovascular Imaging Partners with inHEART to Distribute AI-Driven Digital Twin of the Heart for Advanced Cardiac Procedural Planning in the Electrophysiology Lab
Circle Cardiovascular Imaging Inc. and inHEART Inc. announced a global distribution agreement to promote and market inHEART's AI-enabled digital twin of the heart for advanced cardiac procedural planning.
2024-05
GlobeNewswire
Circle Cardiovascular Delivers a Unified Cardiac Imaging Platform
Circle Cardiovascular Imaging Inc. announced the release of cvi42 v6.4, which expands its all-in-one solution with advanced MR automation, comprehensive coronary plaque, PCAT, and vascular CT analysis and planning tools.
2026-01

Videos

Product demos, reviews, and walkthroughs for cvi42 Coronary Plaque.

View all on YouTube

Frequently Asked Questions

cvi42 Coronary Plaque integrates seamlessly into existing CT workflows and is compatible with all major vendor systems, providing an on-premise AI-enabled solution for comprehensive coronary plaque analysis directly from CCTA scans. Its primary clinical applications include quantifying total, calcified, and non-calcified plaque, enabling more precise risk stratification and informing personalized treatment plans.
cvi42 Coronary Plaque has received 510(k) clearance from the U.S. Food and Drug Administration (FDA), making it available for clinical use in the United States. As an on-premise solution, it allows clinicians to evaluate coronary artery disease without sending patient data to external services, thereby enhancing control over data and reducing PHI privacy and security risks.
While traditional CAC scoring primarily detects calcified plaque, cvi42 Coronary Plaque, through AI-enabled CCTA analysis, provides a detailed quantification of total, calcified, and crucially, non-calcified and low-attenuation plaque. This offers a more comprehensive assessment of atherosclerotic burden and identifies high-risk plaque features that are often missed by calcium scoring alone, leading to improved risk stratification and personalized care.
AI-enabled coronary plaque analysis is covered by a permanent Category I CPT code, 75577, effective January 2026, with Medicare and major commercial payers providing coverage. The on-premise nature of cvi42 Plaque allows imaging sites to retain the majority of the reimbursement, estimated around $900-$1,000 per case, rather than outsourcing analysis and associated billing.
cvi42 Coronary Plaque is intended as an aid to the existing standard of care and does not replace the judgment of a qualified medical practitioner. Users should be aware that the software may use interpolated data, which could potentially give the appearance of healthy tissue in areas where pathology is near or smaller than the scanning resolution.
The AI in cvi42 Coronary Plaque performs automated coronary lumen and wall segmentation and plaque quantification, delivering fast and reproducible results. The system also offers full user control, allowing manual adjustments of lumen, vessel wall, and lesion annotations as needed, providing physicians with interactive control over the analysis.
Circle CVI continually invests in advancing its imaging applications and enhancing cardiac CTA workflows, with cvi42 being a unified platform for various cardiac imaging needs. While specific future features for plaque analysis are not detailed, the platform's design supports ongoing innovation and integration of advanced analytics.

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