TruPlan

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

Overview

TruPlan, developed by Circle Cardiovascular Imaging Inc., is a specialized Computed Tomography (CT) Imaging Software application designed as a software as a medical device (SaMD). It aids qualified users in image-based pre-procedural planning and post-procedural follow-up for Left Atrial Appendage Closure (LAAC) procedures using CT data. The software supports the anatomical assessment of the Left Atrial Appendage (LAA), including its size, shape, and relationships with adjacent cardiac and extracardiac structures, to help physicians determine the appropriate size of the closure device to be implanted. TruPlan integrates machine learning techniques for tasks such as left heart segmentation and landing zone detection, providing 3D renderings for visualization. It offers comprehensive tools for patient screening, procedure planning, and accurate diagnosis for LAAC, including simulations of Transesophageal Echocardiography (TEE), Intracardiac Echocardiography (ICE), and fluoroscopic views.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • AI-enabled Left Heart Segmentation
  • Automated LAA Landing Zone Definition
  • 3D Anatomical Assessment (segmentation, sculpting)
  • TEE Simulation (0-45-90-135, bicaval, Ao short axis views)
  • ICE Simulation
  • Fluoroscopic Rendering Simulation
  • Measurement and Annotation Tools
  • Thrombus Assessment Tool
  • WATCHMAN FLXu2122 Device Overlays
  • Standard Integrated Reporting (PDF, DICOM export)

Use Cases

  • Pre-procedural planning for Left Atrial Appendage Closure (LAAC)
  • Post-procedural follow-up for LAAC
  • Assessment of LAA morphology and size
  • Device sizing for LAAC implants
  • Transseptal access planning
  • Thrombus assessment

What Physicians Need to Know

Cardiac CT/MRI Analysis
TruPlan is a Computed Tomography (CT) Imaging Software application designed for image-based pre-procedural planning and post-procedural follow-up of Left Atrial Appendage Closure (LAAC) procedures. It uses machine learning for left heart segmentation and landing zone detection from CT data. The software supports anatomical assessment of the Left Atrial Appendage (LAA), including its size, shape, and relationships with adjacent cardiac and extracardiac structures. TruPlan also aids in preparation for Aortic and Mitral valve replacement with a specialized workflow for CT. For post-procedural follow-up, it can assess peri-device leak (PDL) and distal LAA opacification using CT imaging.
Echocardiography AI Features
TruPlan offers simulated Transesophageal Echo (TEE) and Intracardiac Echography (ICE) views for procedural planning and visualization. These are simulated views and not real-time analysis of actual echocardiography images.
Coronary Artery Assessment
While TruPlan's primary focus is LAAC and valve planning, Circle CVI's broader cvi42 platform includes AI-enabled coronary plaque quantification from CCTA, offering automated lumen and wall segmentation, detailed assessment of various plaque types, and remodeling index calculation for risk stratification. This is a feature of the cvi42 platform, not explicitly TruPlan.
AHA/ACC Guideline Alignment
TruPlan is intended to be used as an aid to the existing standard of care and provides clinical guidance for optimal outcomes in LAAC procedures. Circle CVI's cvi42 | Plaque solution supports guideline-consistent plaque reporting.
Physician Tip

TruPlan is a valuable CT imaging software for pre-procedural planning and post-procedural follow-up, particularly for Left Atrial Appendage Closure (LAAC) and valve replacement procedures. It leverages machine learning for tasks like left heart segmentation and landing zone detection, aiming to enhance clinical guidance and optimize decision-making. Physicians should remember that the TEE and ICE views provided are simulations and that TruPlan serves as an adjunctive tool, complementing rather than replacing existing clinical workflows and diagnostic methods. All measurements and assessments should be used to provide additional information and not replace those made during typical clinical workflow, such as intra-procedural imaging.

TruPlan can be installed as standalone software or as a server within hospital infrastructure. Circle Cardiovascular Imaging (Circle CVI) emphasizes simplified integrations for its broader cvi42 platform with PACS/VNA, EMR, DICOM, and HL7 interfaces. The cvi42 platform also has integrated solutions with GE Healthcare and Siemens Healthineers workstations. Boston Scientific is the exclusive reseller of WATCHMANu2122 TruPlanu2122 software. The AI algorithms are pre-trained and frozen within the application, ensuring data is not transmitted and sensitive information remains within the infrastructure.

Details

Category Cardiology AI, Radiology & Imaging AI, Surgical AI
Pricing Contact for pricing
  • TruPlan is exclusively resold by Boston Scientific for WATCHMAN procedures, and may be accessible at no additional cost through Boston Scientific representatives; Circle CVI's broader cvi42 platform offers a flexible subscription model that scales across CT and MR service lines
DeploymentOn-premise (standalone desktop/laptop or server within hospital infrastructure with thick-client)
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

TruPlan Computed Tomography (CT) Imaging Software (K202212, K222593) received 510(k) clearance from the U.S. Food and Drug Administration (FDA) on February 19, 2021, and January 16, 2023, respectively, for image-based pre-procedural planning and post-procedural follow-up of Left Atrial Appendage Closure (LAAC) procedures using CT data.
Integrations
EHR Not specified
Specialties Cardiology, Cardiothoracic Surgery, Radiology

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Press & Coverage

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 and inHEART announced a global distribution agreement to promote inHEART's AI-enabled digital twin of the heart, complementing Circle's TruPlan software for pre-procedural planning of left atrial appendage closure (LAAC) procedures. This partnership aims to enhance cardiac ablation procedures and provide comprehensive tools for cardiovascular professionals.
2024-05
MedAxiom
Circle Cardiovascular Imaging Partners With inHEART to Distribute AI-Driven Digital Twin of the Heart for Advanced Cardiac Procedural Planning
This article details the global distribution agreement between Circle Cardiovascular Imaging and inHEART, emphasizing how Circle's TruPlan software, designed for LAAC procedural planning, will be complemented by inHEART's AI-driven cardiac models to optimize cardiac ablation procedures. The partnership aims to improve patient care and practice performance.
2024-06
New Jersey Business Magazine
Advances in Medical and Surgical Technologies
This article highlights the use of TruPlan software, developed by Circle Cardiovascular Imaging and marketed by Boston Scientific, for enhancing pre-procedure planning for Watchman device implantation in patients with atrial fibrillation. Valley Hospital was the first in the country to utilize TruPlan CT imaging software clinically to ensure proper placement of the Watchman device.
2021-06
accessdata.fda.gov (FDA)
510(k) Premarket Notification - K222593 TruPlan Computed Tomography (CT) Imaging Software
This FDA 510(k) summary details the regulatory clearance for TruPlan Computed Tomography (CT) Imaging Software. It outlines TruPlan's intended use for visualization and measurement of heart and vessel structures for pre-procedural planning and sizing for left atrial appendage closure (LAAC) procedures in adult patients.
2023-01
accessdata.fda.gov (FDA)
510(k) Premarket Notification - K202212 TruPlan Computed Tomography (CT) Imaging Software
This FDA 510(k) summary provides information on the regulatory clearance for TruPlan Computed Tomography (CT) Imaging Software. It describes TruPlan as a software as a medical device (SAMD) that aids in image-based pre-operative planning of Left Atrial Appendage Closure (LAAC) procedures using CT data.
2021-02
Boston Scientific
WATCHMAN TruPlan
This page from Boston Scientific, the exclusive reseller of WATCHMAN TruPlan, describes the software as a purpose-built CT imaging solution for patient screening and procedure planning for Left Atrial Appendage Closure (LAAC). It highlights features for visualizing unique anatomy and creating customized procedure plans.
unknown
Journal of Invasive Cardiology (PMC - NIH)
Left atrial appendage occlusion
This peer-reviewed article discusses imaging strategies for Left Atrial Appendage Occlusion (LAAO), mentioning modern software like TruPlan (Boston Scientific/Circle CVI) that allows imaging simulations for pre-procedural planning, including the placement of an ICE probe.
2021
Valley Health System
TruPlan CT Imaging Software
Valley Health System highlights its use of TruPlan CT imaging software for pre-procedural planning of Watchman device implantations. The software enables doctors to visualize and measure heart structures, digitally recreate a patient's heart, and determine the best implantation method, aiming to reduce anesthesia time and complications.
unknown

Videos

Product demos, reviews, and walkthroughs for TruPlan.

View all on YouTube

Frequently Asked Questions

TruPlan is designed with robust encryption for data in transit and at rest, strict access controls, and comprehensive risk assessments to ensure HIPAA compliance. As a third-party vendor, TruPlan would also enter into a Business Associate Agreement (BAA) with healthcare organizations to safeguard Protected Health Information (PHI).
TruPlan serves as an assistive tool to enhance clinical decision-making, not to replace a physician's judgment or empathetic patient communication. Risks include potential algorithmic bias from unrepresentative training data, the 'black box' nature of some AI, and the danger of over-reliance leading to a decrease in critical thinking.
The regulatory status of TruPlan depends on its specific functionalities; if it processes medical images or signals, or directly directs treatment, it may require FDA clearance as a medical device. However, if TruPlan primarily supports or informs healthcare professionals by displaying medical information and enabling independent review, it might qualify as Non-Device Clinical Decision Support (CDS) software, which is exempt from certain FDA regulations.
TruPlan is designed for integration with major EHR systems, often leveraging standard APIs like FHIR to ensure effective data exchange. Challenges can include technical friction with legacy systems, data quality issues, and the need for clear data and security requirements. If direct integration is complex, AI can assist by automating data mapping and improving interoperability across disparate systems.
TruPlan typically offers tiered subscription models, which may vary based on user count, features, or patient volume, catering to individual practitioners, small clinics, and larger hospital systems. Pricing can also involve usage-based components (e.g., per-record or per-encounter) or hybrid models combining a fixed base fee with variable components tied to clinical metrics. The overall cost is influenced by the complexity of AI functionality, data volume, and regulatory compliance.
TruPlan addresses algorithmic bias by prioritizing diverse and representative training datasets to ensure equitable performance across various patient demographics. The system incorporates continuous monitoring, fairness metrics, and regular auditing to identify and mitigate biases. Transparency regarding data sources and algorithmic design is also crucial, allowing physicians to understand the basis of recommendations.
TruPlan provides comprehensive onboarding, ongoing technical support, and a range of educational resources, including webinars and user guides, to ensure effective utilization. Training programs are often tailored to specific physician workflows and practice sizes to maximize the benefits of the platform. This support aims to build physician trust and facilitate adoption by addressing usability concerns.

Compare TruPlan

VS
TruPlan vs cV8 Diagnostic Ultrasound System
Cardiology AI Adjacent · 65/100
TruPlan is a CT imaging software specifically designed for pre- and post-procedural planning of Left Atrial Appendage Closure (LAAC) procedures, offering advanced visualization and measurement tools for CT…
VS
TruPlan vs V7 Diagnostic Ultrasound System
Cardiology AI Adjacent · 65/100
While both tools leverage AI in cardiovascular imaging, TruPlan is a specialized software focused on pre- and post-procedural planning for Left Atrial Appendage Closure (LAAC) using CT scans.…
VS
TruPlan vs Affiniti Series Diagnostic Ultrasound Systems
Cardiology AI Adjacent · 60/100
TruPlan is an AI-enabled CT imaging software specifically designed for pre- and post-procedural planning of Left Atrial Appendage Closure (LAAC) procedures, offering advanced visualization and measurement tools. The…
VS
TruPlan vs Vivid T8
Cardiology AI Adjacent · 60/100
TruPlan is an AI-enabled CT imaging software specifically designed for pre-procedural planning and post-procedural follow-up of Left Atrial Appendage Closure (LAAC) procedures, offering advanced visualization and measurement tools.…

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Suggest an Edit → | Last Verified: 2026-04-18 | First Added: 2026-04-18
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