TruPlan Computed Tomography (CT) Imaging Software
Overview
TruPlan Computed Tomography (CT) Imaging Software, developed by Circle Cardiovascular Imaging, is a software as a medical device designed to aid 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. TruPlan utilizes machine learning techniques for tasks such as Left Heart Segmentation and Landing Zone Detection, providing 3D renderings for visualization. It offers comprehensive visualization, measurement, and annotation tools, along with customizable structured reporting, to facilitate informed decision-making for physicians. TruPlan is intended to be used as an aid to the existing standard of care and does not replace existing software applications for diagnosis or primary planning.
Reviewed by Pouyan Golshani, MD — Interventional Radiologist
Key Features
- Comprehensive visualization for Left Atrial Appendage Closure (LAAC)
- Pre-procedural planning for LAAC procedures
- Post-procedural follow-up for LAAC procedures
- Automated LAA landing zone definition using machine learning
- 3D anatomical assessment, including segmentation and sculpting
- Endoluminal view to LAA and Left Atrium (LA)
- TEE (Transesophageal Echocardiography) simulation with prepopulated views and simultaneous fluoro/3D
- Fluoro Workflow Enhancements
- Measurement and annotation tools for cardiac structures
- Customizable structured reporting tools
- AI/Machine learning for Left Heart Segmentation and Landing Zone Detection
Use Cases
- Left Atrial Appendage Closure (LAAC) procedure planning
- Assessment of LAA size, shape, and relationships with adjacent cardiac structures
- Determining the appropriate size of the closure device for LAAC
- Post-procedural evaluation of LAAC device placement
- Thrombus assessment for LAAC procedures
- Visualization of the heart in advance of Watchman procedures to reduce time under anesthesia and risks
What Physicians Need to Know
TruPlan is an invaluable aid for pre-procedural planning and post-procedural assessment of Left Atrial Appendage Closure (LAAC) procedures, offering detailed CT-based anatomical insights and simulated views. Physicians should leverage its automated 3D segmentation and measurement tools to optimize device selection and placement, potentially reducing procedural time and enhancing efficiency. Remember that TruPlan is intended as a planning aid and does not replace the physician's diagnostic responsibilities or intra-procedural imaging. Ensure high-quality CT image acquisition for the most accurate analysis.
TruPlan is designed for seamless integration into existing clinical workflows by supporting DICOM data import from PACS or local storage, with optional PACS connectivity. It is compatible with both MacOS and PC environments, facilitating accessibility and collaboration across different workstations.
Details
| Category | Cardiology AI, Radiology & Imaging AI, Surgical AI |
| Pricing | Contact for pricing. |
| Deployment | On-premise (integrates with PACS/VNA, AI algorithms processed within user infrastructure). |
| Compliance | |
| BAA Available | Unknown AI-estimated |
| HIPAA Compliant | Unknown AI-estimated |
| FDA Status |
Yes AI-estimated TruPlan Computed Tomography (CT) Imaging Software received FDA 510(k) clearance (K222593) on January 18, 2023. It is classified as a Class II medical device, an Automated Radiological Image Processing System (Product Code LLZ), intended for pre-procedural planning and post-procedural follow-up of Left Atrial Appendage Closure (LAAC) procedures using CT data. |
| Integrations | |
| EHR | Not specified |
| Specialties | Cardiology, Radiology |
What the Web Says
TruPlan Computed Tomography (CT) Imaging Software, developed by Circle Cardiovascular Imaging Inc. and exclusively resold by Boston Scientific, is a purpose-built software for comprehensive visualization and pre-procedural planning, as well as post-procedural evaluation, for Left Atrial Appendage Closure (LAAC) procedures. It aims to enhance patient screening, optimize procedure planning, and aid in accurate diagnosis for LAAC, offering tools for segmentation of cardiovascular structures, 2D review, volume rendering, and MPR. The software is designed to be user-friendly with intuitive controls and automation for CT analysis.
Overall: PositiveStrengths
- Comprehensive visualization and pre-procedural planning for LAAC.
- Aids in accurate diagnosis and post-procedural evaluation for LAAC.
- Intuitive controls and automation make CT analysis simple and user-friendly.
- Can lead to higher procedural completion rates and faster procedure times.
- Reduces time under anesthesia and associated risks and post-procedural complications.
- Offers simulated TEE, ICE, and fluoroscopic views for enhanced planning.
Limitations
- Measurements made in TruPlan should only provide additional information and not replace typical clinical workflow measurements.
- Simulated images (Fluoro, TEE, ICE modules) are not real.
- Quantitative analysis is dependent on the quality and correctness of the image source data (CT scans).
- Software performance may slow down if other applications are running on the same machine.
- Operating system updates might require an updated version of TruPlan.
- Not all modules or features are available in every region.
Based on reviews from: Boston Scientific, Circle Cardiovascular Imaging (Circle CVI), YouTube, Valley Health System, accessdata.fda.gov, HMP Global Learning Network
Last updated: 2026-07-17
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RSNA 2023: cvi42 Integration Demo by Circle Cardiovascular Imaging
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