cvi42 Auto Imaging

by Circle Cardiovascular Imaging  · Based in Canada → — We Enhance Healthcare Outcomes by Unlocking Data Insights from Medical Imaging Procedures to Empower Efficient and Reliable Decision-Making across the Medical Landscape.
Cardiology Radiology Vascular Surgery
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Regulatory Status Disclosed

Overview

cvi42 Auto Imaging is an advanced software as a medical device (SaMD) developed by Circle Cardiovascular Imaging, designed for the comprehensive viewing, post-processing, qualitative, and quantitative evaluation of cardiovascular Magnetic Resonance (MR) and Computed Tomography (CT) images. This AI-powered platform leverages machine learning techniques to aid in semi-automatic contouring of regions of interest, providing clinically validated tools for accurate diagnosis and seamless integration into clinical workflows. It supports physicians in confirming the presence or absence of lesions in blood vessels, evaluating and documenting such lesions, and performing calcium scoring. The software aims to improve patient throughput, accuracy, and reproducibility by optimizing decision-making with its cutting-edge AI, reducing clerical workload, and enhancing reporting efficiency.

The platform is a vendor-neutral solution, compatible with various scanning platforms and existing systems like PACS/VNA, EMR, DICOM, and HL7, making it adaptable to diverse imaging environments. It is utilized globally in over 1700 hospitals across more than 90 countries, including top medical centers, for both clinical and research purposes. Recent advancements include cvi42 | Plaque, an AI-enabled, on-premise solution for comprehensive coronary plaque analysis, further enhancing diagnostic precision and risk stratification for coronary artery disease.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • AI-enabled automated contouring and segmentation
  • Cardiac MR analysis (Function, Flow, Tissue Characterization, Strain)
  • Cardiac CT analysis (Calcium Scoring, Coronary Arteries, Plaque Assessment)
  • Vascular CT analysis (diagnosis, planning, surveillance)
  • Quantitative analysis (volume, mass, function, signal intensity, plaque)
  • 3D visualization and multiplanar reconstruction (MPR)
  • Simplified and smart reporting with infographics and CAD-RADS classification
  • Multi-modality support (MR, CT) and vendor-neutral compatibility
  • Data import/export capabilities
  • Seamless integration with PACS/VNA, EMR, DICOM, HL7

Use Cases

  • Diagnostic reporting for coronary artery disease, structural heart disease, and heart failure
  • Quantitative assessment of cardiac images and adjacent vessels
  • Coronary plaque analysis (volume, burden, composition, distribution)
  • Endovascular procedure planning and post-treatment surveillance
  • Clinical studies and academic research (e.g., Strain Analysis, T1/T2 Mapping, 4D Flow)
  • Improving workflow efficiency and standardizing reporting in cardiac imaging labs and hospitals

What Physicians Need to Know

ECG/EKG Analysis Capability
Not a primary feature; cvi42 Auto Imaging focuses on advanced Cardiac CT and MRI analysis.
Cardiac CT/MRI Analysis
Comprehensive AI-driven analysis for both Cardiac MR and CT. For MR, it includes AI-based contouring for all four heart chambers, tissue characterization, 4D Flow with automated segmentation, quantitative perfusion, and strain analysis. For CT, it offers AI-driven ventricular segmentation, calcium scoring, and advanced coronary artery and plaque assessment.
Arrhythmia Detection Accuracy
Not a primary feature; the tool focuses on anatomical and functional assessment from imaging, not electrophysiological arrhythmia detection.
Heart Failure Risk Prediction
Provides critical quantitative data (e.g., LV/RV volumes and function, myocardial strain) from MR and CT images that are essential for heart failure evaluation and can be leveraged in machine learning models for risk prediction.
Coronary Artery Assessment
Offers AI-enabled coronary plaque quantification (total, calcified, non-calcified), automated coronary lumen and wall segmentation, per-lesion and per-vessel analysis, and remodeling index assessment to identify high-risk plaques. Includes zero-click primary and secondary coronary artery centerline segmentation and automated detection of suspected lesions. Also provides calcium scoring and pericoronary adipose tissue (PCAT) analysis (for research use).
Cardiac Monitoring Integration
No explicit mention of integration with real-time cardiac monitoring devices; the focus is on post-processing and analysis of acquired imaging data.
AHA/ACC Guideline Alignment
Supports standardized reporting with integrated CAD-RADS classification. FDA clearance for cvi42 | Plaque and the assignment of a permanent Category I CPT code for AI-enabled coronary plaque analysis signify its recognition as standard clinical care.
Real-Time Alert Capability
No explicit mention of real-time alert capabilities for critical findings directly from image analysis; the platform emphasizes comprehensive analysis and reporting.
Physician Tip

Leverage cvi42 Auto Imaging's AI-powered automation for rapid, reproducible, and accurate quantification of cardiac MR and CT studies, enhancing diagnostic confidence and streamlining workflows. The on-premise solution ensures data control and potentially faster turnaround times for critical assessments like coronary plaque analysis and ventricular function. Utilize the comprehensive reporting features, including CAD-RADS classification, for standardized communication and personalized patient care planning.

cvi42 is designed for seamless integration into existing clinical workflows, supporting DICOM standard format and offering HL7 integration for reporting. It is compatible with major vendor systems (e.g., GE Healthcare, Siemens Healthineers) and has expanded its capabilities through collaboration with Astute Imaging for AI-driven vascular CT analysis, providing a unified platform for cardiac, vascular, and structural heart analysis.

Details

Category Cardiology AI, Radiology & Imaging AI
Pricing Contact for pricing
  • Information on cvi42 price is not publicly listed due to the complexity of licensing and modularity (e.g., specific modules like Strain require additional licenses)
DeploymentOn-premise, Stand-alone, Networked environment. Cloud compatibility is mentioned as a feature, but recent FDA clearances for modules like cvi42 | Plaque emphasize on-premise deployment for data control.
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

cvi42 Auto Imaging Software Application (K213998) was cleared by the FDA on July 28, 2022, as a software as a medical device (SaMD) for viewing, post-processing, qualitative and quantitative evaluation of cardiovascular MR and CT images. Additionally, cvi42 | Plaque received 510(k) clearance on October 29, 2025, for AI-powered, on-premise coronary plaque analysis.
Integrations
EHR Not specified
Specialties Cardiology, Radiology, Vascular Surgery

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Press & Coverage

FDA
cvi42 Auto Imaging Software Application
The cvi42 Auto Imaging Software Application (K213998) by Circle Cardiovascular Imaging Inc. is a software as a medical device (SaMD) intended for evaluating CT and MR images of the cardiovascular system. It combines digital image processing, visualization, quantification, and reporting tools to support physicians in diagnosis and treatment planning.
2022-07
FDA
510(k) Premarket Notification - cvi42 Auto Imaging Software Application
This FDA 510(k) premarket notification details the clearance of the cvi42 Auto Imaging Software Application, classifying it as a Class II medical device. It lists Circle Cardiovascular Imaging, Inc. as the applicant and provides regulatory information.
2022-07
MDTmag.com
cvi42 Auto Imaging Software
cvi42 Auto Imaging Software is an AI-driven cardiac imaging solution that automates coronary artery analysis, plaque quantification, and functional assessment to enhance diagnostic precision and workflow efficiency. It offers server-side pre-processing of CT studies and AI-enabled segmentation.
2025-10
Innolitics
2025 Year in Review: Cardiology AI/ML SaMD 510(k) Clearances
This article provides a comprehensive analysis of 2025 cardiology AI/ML clearances, mentioning cvi42 Auto Imaging Software Application (K213998) by Circle Cardiovascular Imaging Inc. as a cleared device in 2022.
2026-01
FDA
cvi42 Coronary Plaque Software Application (K251027)
This regulatory document for the cvi42 Coronary Plaque Software Application (K251027) references the cvi42 Auto Imaging Software Application (K213998) as a primary predicate device.
2025-10
Orthogonal
SaMD Cleared by the FDA: The Ultimate Running List
Orthogonal's list of FDA-cleared Software as a Medical Devices (SaMD) includes the cvi42 Auto Imaging Software Application by Circle Cardiovascular Imaging Inc., cleared on July 28, 2022, for radiology.
2024-10
Physician AI Tools
SENSICARDIAC vs cvi42 Auto Imaging - Medical AI Tools for Physicians
This comparison highlights cvi42 Auto Imaging as an AI-driven solution for comprehensive analysis of cardiovascular MR and CT images, emphasizing its capabilities in automated contouring, plaque quantification, and multi-modality support for precise diagnosis and streamlined reporting.
2026-07
Physician AI Tools
cvi42 Auto Imaging vs VX1+ - Physician AI Tools
This article compares cvi42 Auto Imaging with VX1+, noting that cvi42 Auto Imaging focuses on comprehensive analysis of cardiovascular MR and CT images for diagnosis and workflow streamlining, offering AI-powered analysis for diagnostic purposes and detailed pre-procedural planning.
2026-07

Videos

Product demos, reviews, and walkthroughs for cvi42 Auto Imaging.

View all on YouTube

Frequently Asked Questions

cvi42 Auto Imaging, particularly the cvi42 | Plaque module, leverages AI for automated coronary lumen and vessel wall segmentation, enabling precise quantification of atherosclerotic plaque volume, burden, composition, and distribution directly from CCTA scans. This AI-driven analysis supports enhanced risk stratification and personalized treatment planning for coronary artery disease.
cvi42 | Plaque has received 510(k) clearance from the U.S. Food and Drug Administration (FDA), indicating its regulatory compliance for clinical use. As an on-premise solution, it allows for the evaluation of coronary artery disease without sending patient data to external reading services, thereby reducing PHI privacy and security risks.
Several alternatives exist for AI-powered cardiac imaging analysis, including platforms like Arterys Cardio AI, syngo.via, IntelliSpace Cardiovascular, and EchoPAC, which offer various features for cardiac MRI, CT, and echocardiography. Other competitors mentioned include Caas MR 4D Flow, AIATELLA, and Vitrea Advanced Visualization, each with distinct capabilities in cardiovascular imaging.
Circle CVI offers a flexible 'Elevate pricing structure' for cvi42, which is a subscription model designed to scale with imaging volume and growth across CT and MR service lines. The AI-enabled coronary plaque analysis performed by cvi42 is reimbursable under the Category I CPT code 75577, effective January 1, 2026, with Medicare and major commercial insurers providing coverage and enabling sites to retain reimbursement.
While cvi42's AI offers significant automation, general AI segmentation in cardiac imaging can sometimes have limitations, such as potential underestimation of left ventricular volumes if the LVOT is not fully included or due to underfitting of contours. However, cvi42 provides full user control, allowing for manual adjustments of AI-generated annotations as needed to ensure accuracy.

Compare cvi42 Auto Imaging

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cvi42 Auto Imaging vs KardiaPro
Cardiology AI Adjacent · 60/100
cvi42 Auto Imaging and KardiaPro both focus on cardiovascular health with AI, but they address different aspects of patient care. cvi42 Auto Imaging is designed for in-depth analysis…
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cvi42 Auto Imaging vs EchoNext
Cardiology AI Adjacent · 65/100
These tools are adjacent in their focus on cardiovascular health but differ significantly in their input data and application. cvi42 Auto Imaging analyzes cardiovascular MR and CT images…
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cvi42 Auto Imaging vs iPredict Eye Screening
Cardiology AI Adjacent · 65/100
Tool A (cvi42 Auto Imaging) focuses on comprehensive AI-powered analysis of cardiovascular MR and CT images for diagnosis, plaque quantification, and workflow streamlining. Tool B (iPredict Eye Screening)…
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cvi42 Auto Imaging vs Cardiomo
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Tool A (cvi42 Auto Imaging) is an AI-powered software for comprehensive analysis of cardiovascular MR and CT images, primarily used by clinicians for precise diagnosis and streamlined workflows…

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