CVI42

by CIRCLE CARDIOVASCULAR IMAGING  · Based in Canada → — One Platform for All Your Advanced Cardiac Imaging Needs
Cardiology Cardiothoracic Surgery Radiology

Contact for pricing
Regulatory Status Disclosed

Overview

CVI42 by Circle Cardiovascular Imaging is an advanced, AI-enabled software platform designed for comprehensive cardiovascular and cerebrovascular imaging analysis. It provides clinically validated tools for accurate diagnosis, procedural planning, and post-treatment management across various cardiovascular workflows. The platform integrates advanced MR automation, comprehensive coronary plaque, PCAT, and vascular CT analysis and planning tools, with seamless integration into existing imaging workflows. CVI42 is engineered for workflow optimization, allowing cardiac teams to interpret studies faster with greater reproducibility and accuracy, leading to more consistent, data-driven reporting and increased throughput. It supports the full continuum of cardiovascular care, from diagnosis to long-term disease management, and is trusted by leading healthcare institutions worldwide.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • AI-automated coronary lumen and wall segmentation
  • Comprehensive coronary plaque analysis (calcified, non-calcified, low-attenuation)
  • Advanced CMR automation (T1 mapping, 4D flow pre-processing)
  • Vascular CT analysis and planning tools
  • Automated detection of suspected coronary lesions
  • Pericoronary Adipose Tissue (PCAT) analysis (research use only)
  • 3D visualization and image fusion
  • Automated contouring of regions of interest
  • Multi-vendor and multi-modality support (CT, MR)
  • Simplified and enhanced reporting

Use Cases

  • Diagnosis of cardiovascular diseases
  • Endovascular procedure planning
  • Post-treatment surveillance and management
  • Risk stratification for coronary artery disease
  • Evaluation of heart failure and structural heart disease
  • Research in cardiovascular imaging

What Physicians Need to Know

Cardiac CT/MRI Analysis
CVI42 provides comprehensive AI-driven analysis for both Cardiac CT and MRI studies. For Cardiac MR, it offers tools for function, flow, tissue characterization (including T1 mapping), perfusion, and advanced 4D flow analysis with AI-based contouring for ventricles and atria. For Cardiac CT, it includes AI-automated coronary lumen and wall segmentation, calcium scoring, and detailed plaque assessment.
Heart Failure Risk Prediction
The software is used to quantify left ventricular (LV) and right ventricular (RV) volumes and function from CMR images, which are crucial for heart failure evaluation. It can also quantify epicardial adipose tissue (EAT) volume and LV strain parameters from cardiac MRI, which may help identify patients at higher risk of heart failure with preserved ejection fraction (HFpEF).
Coronary Artery Assessment
CVI42 | Plaque offers AI-enabled, on-premise quantification of atherosclerotic burden from CCTA scans. This includes automated segmentation, detailed assessment of calcified, non-calcified, and low-attenuation plaques, per-lesion and per-vessel analysis, and remodeling index calculation to identify high-risk plaques. It also supports calcium scoring and integrates CAD-RADS classification for standardized reporting. The solution has received FDA 510(k) clearance and has an assigned Category I CPT code for AI-enabled coronary plaque analysis.
AHA/ACC Guideline Alignment
CVI42's advanced CMR and CCTA analysis capabilities support the evaluation of cardiac structure and function and coronary artery disease, aligning with the types of imaging recommendations found in AHA/ACC guidelines. The platform's standardized protocols and reports also aim to support guideline adherence.
Physician Tip

Leverage CVI42's AI-driven automation for cardiac CT and MR to significantly reduce post-processing time and enhance reproducibility in quantifying cardiac function, flow, and tissue characteristics. Utilize the cvi42 | Plaque module for comprehensive, on-premise coronary plaque analysis, including detailed characterization of plaque burden and composition, which can aid in precise risk stratification and personalized treatment planning for coronary artery disease. The ability to perform in-house plaque analysis with FDA-cleared AI and a dedicated CPT code can also streamline workflows and support reimbursement. Furthermore, the platform's insights into LV/RV function and EAT volume from CMR can contribute to a more informed assessment of heart failure risk.

CVI42 is designed for seamless integration into existing clinical workflows. It is vendor-independent, compatible with all major CT vendor systems, and offers full DICOM connectivity to PACS for image transfer and saving reports. It also supports HL7 compatibility for integration with reporting systems and EMRs, with specific integration with PowerScribe for automated transcription and improved workflow continuity. The platform can be deployed as a standalone workstation or in a client/server environment, providing flexibility for different hospital and practice settings.

Details

Category Cardiology AI, Radiology & Imaging AI
Pricing Contact for pricing
  • Flexible subscription that scales across CT and MR service lines; specific modules like Strain require additional licenses
DeploymentOn-premise solution
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

CVI42 (K141480) received 510(k) clearance from the U.S. FDA on August 22, 2014, for viewing, post-processing, qualitative, and quantitative evaluation of cardiovascular CT or MR images for diagnostic information. More recently, cvi42 | Plaque (K251027) received 510(k) clearance on October 27, 2025, for AI-enabled, on-premise quantification of atherosclerotic burden.

Integrations
EHR Not specified
Specialties Cardiology, Cardiothoracic Surgery, Radiology

What the Web Says

CVI42, developed by Circle Cardiovascular Imaging, is a medical imaging software platform designed for the analysis of cardiovascular and neurovascular CT and MRI scans. It utilizes AI and clinical validation to provide automated diagnosis tools, aiming to streamline workflows and enhance diagnostic accuracy for healthcare professionals. The software is used globally in over 1,700 sites, including many top hospitals. Recently, CVI42 | Plaque, an AI-powered, on-premise solution for coronary plaque analysis, received FDA clearance, allowing for in-house evaluation of coronary artery disease.

Overall: Positive

Strengths

  • Comprehensive cardiovascular imaging solution for both MR and CT studies.
  • AI-powered tools for automated analysis, including plaque quantification and segmentation, leading to high-speed and accurate results.
  • Enhances workflow efficiency and reduces diagnostic friction by unifying anatomy, function, and inflammation analysis in a single platform.
  • On-premise solution for plaque analysis allows clinicians greater control over data, improved processing times, and potential for maximized reimbursement.
  • Strong customer service and a commitment to continuous improvements and innovation.
  • Vendor-agnostic and integrates smoothly with existing CT platforms and PACS/reporting systems.

Limitations

  • High initial investment and ongoing maintenance costs may be a barrier for smaller clinics.
  • Some advanced features like CT Strain and Quantitative Perfusion are for research use only.
  • Capterra and SoftwareSuggest show no user reviews, making it difficult to gauge widespread user satisfaction from those platforms.
  • ITQlick rates its cost as 4/10, indicating it is less expensive than the average medical imaging tool, but still a significant investment.
  • Setting up and navigating the system can feel complex at first, especially for smaller teams.

Based on reviews from: Capterra, ITQlick, DAIC, TechnologyCounter, SourceForge, Circle CVI Global, RAD Magazine, SoftwareSuggest, VA.gov, AuntMinnie, accessdata.fda.gov, G2

Last updated: 2026-07-20

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Press & Coverage

Circle Cardiovascular Imaging Inc. (Press Release)
Circle CVI Announces FDA Clearance for cvi42 | Plaque for Coronary Artery Disease Evaluation
Circle CVI announced FDA 510(k) clearance for its AI-enabled cvi42 | Plaque solution, allowing on-premise comprehensive coronary plaque analysis to enhance diagnostic workflows and patient care. This solution provides fast, accurate, and reproducible results for quantifying total, calcified, and non-calcified plaque.
2025-10
MD+DI Online
FDA Clears Circle Cardiovascular Imaging's cvi42 | Plaque Solution
The FDA has cleared Circle CVI's cvi42 | Plaque solution, an AI-enabled tool for comprehensive coronary plaque analysis directly on-premise, which aims to enhance diagnostic workflows and patient care by delivering fast, accurate, and reproducible results.
2025-12
AuntMinnie
Circle CVI expands cvi42 platform with vascular CT analysis
Circle Cardiovascular Imaging has expanded its cvi42 platform to include vascular CT analysis through a collaboration with Astute Imaging, integrating AI-driven technology for diagnosis, endovascular procedure planning, and post-treatment surveillance.
2026-03
GlobeNewswire
Circle Cardiovascular Imaging Expands cvi42 Platform with Advanced Vascular CT Capabilities
Circle CVI announced the expansion of its cvi42 cardiovascular imaging platform to include advanced Vascular CT analysis, a solution enabled by integrating Astute Imaging's AI-driven vascular analysis technology. This allows clinicians to analyze complex vascular anatomy within the same platform used for cardiac imaging.
2026-03
GlobeNewswire
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 to benefit from newly activated reimbursement under permanent Category I CPT code 75577, effective January 1, 2026.
2026-01
DAIC (Diagnostic and Interventional Cardiology)
Circle Cardiovascular Delivers a Unified Cardiac Imaging Platform with Latest cvi42 v6.4 Release
Circle CVI released cvi42 v6.4, the latest version of its post-processing software, expanding its all-in-one solution with advanced MR automation, comprehensive coronary plaque, PCAT, and vascular CT analysis and planning tools.
2026-01
European Heart Journal - Cardiovascular Imaging
Quality control of cardiac magnetic resonance imaging segmentation, feature tracking, aortic flow, and native T1 analysis using automated batch processing in the UK Biobank study
This study outlines a visual quality control process for image analysis using automated batch processing with CVI42 software for UK Biobank CMR scans, demonstrating high quality and suggesting that statistical outlier removal is sufficient for quality control in larger datasets.
2024-09
AuntMinnie
FDA approves Circle's new cardiac CT function module
The FDA granted 510(k) premarket approval to Circle Cardiovascular Imaging's cardiac CT Function software application, coinciding with the cvi42 v6.1 release, which includes machine-learning AI enhancements and upgrades for coronary analysis.
2024-06

Videos

Product demos, reviews, and walkthroughs for CVI42.

View all on YouTube

Frequently Asked Questions

CVI42 is designed for seamless integration into existing CT and MR workflows, offering full DICOM and PACS connectivity. It operates as an on-premise solution, allowing clinicians to perform comprehensive cardiac and vascular analysis directly within their clinical environment without sending patient data to external services.
CVI42 leverages AI-enabled technology for fast, accurate, and reproducible quantification of total, calcified, and non-calcified coronary plaque from CCTA scans, aiding in precise risk stratification and personalized treatment plans. It also provides automated tools for cardiac MR analysis, including function, flow, and tissue characterization.
Yes, CVI42 | Plaque has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for clinical use. As an on-premise solution, it allows for the evaluation of coronary artery disease without sending patient data to an external reading service, providing clinicians with greater control over their data and supporting HIPAA compliance through local data management.
While CVI42 is a leading platform, alternatives in cardiac imaging analysis include solutions like Caas MR 4D Flow, AIATELLA, Arterys Cardio AI, and other advanced multimodality imaging platforms such as syngo.via and IntelliSpace Cardiovascular. These competitors also offer various AI-powered tools for cardiac MRI and CT analysis.
CVI42 typically uses a flexible subscription-based pricing structure, such as Circle CVI's 'Elevate' model, which scales across CT and MR service lines. The availability of dedicated CPT codes for AI-enabled coronary plaque analysis, including a permanent Category I CPT code (75XX6) effective January 2026, facilitates national pricing and enables physician reimbursement, allowing practices to retain most of the reimbursement.
CVI42's semi-automated machine learning algorithms are primarily intended for an adult population, and its use is limited to cardiac images acquired from MR or CT scanners. While AI improves efficiency and reproducibility, it's crucial for qualified medical professionals to verify and correct results, as AI performance can be impacted by image quality and may not always be interchangeable with manual analysis in complex cases.

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View company profile →

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