3mensio Workstation

by Pie Medical Imaging BV  · Based in Netherlands → — Software for pre-operative sizing and planning
Cardiology Cardiothoracic Surgery Vascular Surgery

Regulatory Status Disclosed

Overview

The 3mensio Workstation, a product line of Pie Medical Imaging’s portfolio, is an advanced software solution designed for pre-operative sizing and planning in cardiovascular interventions. It provides comprehensive tools for advanced visualization and analysis for diagnostics in cardiology and radiology. The workstation is comprised of two primary modules: Structural Heart and Vascular.

The 3mensio Structural Heart module offers dedicated workflows for assessing and measuring various heart structures, including the aortic valve, mitral valve, pulmonary valve, tricuspid valve, coronary arteries, and left atrial appendage. This facilitates the planning of complex procedures such as Transcatheter Aortic Valve Implantation (TAVI), Mitral Replacement and Repair (TMVR and TMVr), Pulmonary Valve Implantation (PPVI), Tricuspid Replacement and Repair (TTVR and TTVr), and Left Atrial Appendage Occlusion (LAAO).

The 3mensio Vascular module is specifically tailored for sizing and planning Endovascular Aneurysm Repair (EVAR), Thoracic Endovascular Aortic Repair (TEVAR), and Fenestrated Endovascular Repair (FEVAR) procedures. It aids physicians in identifying calcifications, aneurysms, and other anomalies, enabling quick and reliable preparation for various types of vascular surgery.

The software works with all major medical image formats, including DICOM, and can access multiple data stores and networks, including PACS systems. It can combine 2D scan slices into comprehensive 3D models and display supporting ultrasound and X-ray Angio data, accurately representing different tissue types.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Pre-operative sizing and planning
  • Structural Heart module with dedicated workflows
  • Vascular module for EVAR, TEVAR, FEVAR procedures
  • Analysis of aortic valve, mitral valve, coronary procedures, LAA closures
  • Automatic detected centerline
  • 3D image reconstruction and analysis from CTA images
  • Integrated manufacturer stent order sheets (PDF export)
  • Visualization and image reconstruction techniques (2D, Volume Rendering, MPR, Curved MPR, etc.)
  • Measurement and annotation tools
  • DICOM compliant medical images support
  • Export of measurements to EVARplanning

Use Cases

  • Pre-operative planning for TAVI, TMVR, TMVr, PPVI, TTVR, TTVr, LAAO
  • Sizing and planning of EVAR, TEVAR, FEVAR procedures
  • Assessment of heart structures for replacement or repair procedures
  • Assessment of vessels to identify calcifications, aneurysms, and other anomalies
  • Aid in reading and interpreting DICOM compliant medical images of the heart and vessels
  • Postoperative evaluation

What Physicians Need to Know

Cardiac CT/MRI Analysis
The 3mensio Workstation is a multimodality platform primarily focused on advanced 3D and 4D analysis of cardiac CT data for structural heart and vascular procedures. It supports automatic segmentation of cardiovascular structures, including the aortic root, mitral valve, and ventricles. The software provides detailed measurements for pre-operative planning, such as annular dimensions, LVOT clearance, and relationships with surrounding structures. It also features a semi-automated calcium quantification module for coronary arteries and aortic valves, which has shown excellent correlation with manual analysis.
Echocardiography Analysis Capability
The workstation includes workflows for analyzing echocardiographic images, including 3D TTE/TEE data. It offers conventional measurements such as distances, angles, and Doppler gradients. Furthermore, it can assist in the optimal planning of TEE views based on CT data, integrating multiple imaging modalities for comprehensive assessment.
Coronary Artery Assessment
3mensio Structural Heart facilitates pre-operative planning for coronary procedures. It supports the quantification of dimensions and calcifications (calcium scoring) in coronary arteries, aiding in the diagnosis and planning of interventions. The software allows for precise measurements of the distance of coronary orifices from the aortic valve and assessment of coronary vessel dimensions.
AHA/ACC Guideline Alignment
While not explicitly stating direct AHA/ACC guideline alignment, the 3mensio Workstation's comprehensive pre-operative planning for Transcatheter Aortic Valve Implantation (TAVI) and other structural heart interventions aligns with recommendations from committees like ESC/EACTS/EAPCI for patient selection based on multiple imaging modalities. Its detailed assessment tools support data-driven decisions crucial for guideline-compliant procedures.
AI Features (Automation)
The workstation incorporates advanced automation features, including automatic segmentation of cardiovascular structures and automatic centerline detection, which streamline the analysis workflow. While often described as 'semi-automated,' these capabilities leverage intelligent algorithms to reduce analysis time and improve reproducibility, contributing to efficient pre-operative planning.
Physician Tip

For optimal utilization of 3mensio Workstation, physicians should prioritize high-quality, ECG-gated CT data for comprehensive structural heart and vascular planning. Leverage the semi-automated segmentation and measurement tools to standardize pre-operative assessments for procedures like TAVI, TMVR, and LAAO. The multimodality support allows for integrated analysis of CT, echocardiography, and angiography, providing a holistic view for complex cases. Remember that while the software offers significant automation, expert clinical judgment remains crucial for confirming segmentations and interpreting measurements in the context of individual patient anatomy.

3mensio Workstation is designed for seamless integration into existing hospital workflows. It supports DICOM-compliant medical images and can access data from PACS servers, DICOM CDs, USB drives, and across networks. The software also offers full integration capabilities with third-party systems, including cathlabs and MRI systems, facilitating efficient data exchange and multidisciplinary collaboration. Customizable reporting tools and the ability to export images and measurements further enhance communication within healthcare teams.

Details

Category Cardiology AI, Surgical AI
Pricing Unknown
DeploymentOn-premise (Windows PC), Network, Cloud
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

The 3mensio Workstation has received multiple FDA 510(k) clearances, including K120367 (cleared April 17, 2012), K153736 (predicate device), and K250330 (cleared January 6, 2026). It is intended to provide cardiologists, radiologists, and clinical specialists with additional information to aid in reading and interpreting DICOM compliant medical images of the heart and vessels for pre-operational planning, sizing, and postoperative evaluation.

Integrations
EHR Not specified
Specialties Cardiology, Cardiothoracic Surgery, Vascular Surgery

What the Web Says

3mensio Workstation is a medical imaging software developed by Pie Medical Imaging, designed for pre-operative sizing and planning, particularly for structural heart and vascular procedures. It offers advanced 3D visualization and analysis tools for cardiologists, vascular surgeons, and radiologists. The software aims to improve the quality and efficiency of cardiovascular image analysis, ultimately optimizing patient treatment.

Overall: Positive

Strengths

  • Provides precise and reproducible measurements for pre-procedural planning.
  • Offers a structured approach to analysis, simplifying complex workflows.
  • Includes automatic functionalities like nadir point detection, calcium volume scoring, and polygon measurements, with flexibility for manual adjustments.
  • Features a 'Virtual Valve' function for device visualization and comparison, aiding in optimal device selection.
  • Reduces procedure time and radiation exposure through simulated angio view and automatic cusp overlap view.
  • Runs on standard PCs with powerful graphics processing units, potentially saving hardware costs.

Limitations

  • Requires multiple practices to get accurate measurements.
  • Customer service received a low rating (0.0 out of 5) on Capterra.
  • Advanced 3D workstations can be complex, expensive, and time-consuming to learn.
  • Conventional evaluation of MSCT data with 3mensio Workstation may require expertise not always available outside of radiology departments.
  • Some alternatives are praised for better ease of use and integrations.

Based on reviews from: G2, Capterra, SourceForge, AuntMinnie, EuroIntervention, Pie Medical Imaging, Veterans Affairs, 3mensio Workstation Download, SoftwareWorld, App Store, accessdata.fda.gov, Meghav Shah

Last updated: 2026-07-20

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Press & Coverage

Pie Medical Imaging
Release of 3mensio 10.0!
Pie Medical Imaging announced the launch of 3mensio Workstation version 10.0, evolving from TAVR planning software to a multimodality Structural Heart imaging platform. New features include optimal planning of TEE views based on CT data and a dedicated workflow for planning and sizing on 3D TTE/TEE data.
2022-05
FDA
Class 2 Device Recall 3mensio Workstation
The FDA issued a Class 2 device recall for 3mensio Workstation software versions 10.6 and 10.7 due to an issue where adjusting the 12h position for clock measurements in fenestrated analysis does not update other clock measurements, potentially leading to incorrect stent graft fenestration placement.
2025-08
GOV.UK (MHRA)
Field Safety Notices: 4 to 8 May 2026
The Medicines and Healthcare products Regulatory Agency (MHRA) published a field safety notice for Pie Medical Imaging B.V.'s 3mensio Workstation, Model 10.7, including service packs 1-5, in April 2026.
2026-05
GOV.UK (MHRA)
Field Safety Notices: 30 June to 4 July 2025
The MHRA also issued a field safety notice in June 2025 for Pie Medical's 3mensio Workstation, models 10.6 and 10.7 (including service packs), related to radiology DICOM image processing application software.
2025-07
BfArM
Urgent Field Safety Notice for 3mensio Workstation by Pie Medical Imaging B.V.
The German Federal Institute for Drugs and Medical Devices (BfArM) published an urgent field safety notice for 3mensio Workstation by Pie Medical Imaging B.V. in July 2025, concerning medical data processing software.
2025-07
Canada.ca
3mensio Workstation - Canada.ca - Recalls and Safety Alerts
Health Canada issued a recall for 3mensio Workstation (version 10.6) in July 2025 due to incorrect visualization of clock positions in the fenestration diagram, which could potentially harm patients.
2025-07
MDPI
Evaluation of Prospective ECG-Triggered CT Scan as a Practical Alternative to Standard Retrospective ECG-Gated Scan for Pre-TAVI Patients
A study published in January 2025 utilized 3mensio Workstation for reviewing aortic root anatomy and aorta-iliofemoral vasculature in pre-TAVI patients, comparing prospective ECG-triggered CT scans to retrospective ECG-gated scans.
2025-01
MDPI
Quantification of Aortic Valve Calcification in Contrast-Enhanced Computed Tomography
Research published in April 2024 used 3mensio Workstation Version 10.1 for image processing and analysis, including quantification of aortic valve calcification using the Agatston score, in contrast-enhanced computed tomography.
2024-04

Videos

Product demos, reviews, and walkthroughs for 3mensio Workstation.

View all on YouTube

Frequently Asked Questions

The AI in 3mensio Workstation is designed to automate and enhance various measurement and analysis tasks, particularly in cardiovascular imaging. It can streamline pre-procedural planning for complex cases like TAVI/TEVAR by providing automated segmentations and measurements, potentially reducing manual effort and variability.
3mensio Workstation, including its AI-powered features, is FDA 510(k) cleared and CE marked for clinical use. Regarding data privacy, it adheres to industry standards and regulations like GDPR, with the company adopting organizational and technical procedures to ensure personal data security and confidentiality.
While highly accurate, AI algorithms can have limitations, especially with atypical anatomies or image artifacts, and may not replace clinical judgment. Physicians should always review and validate AI-generated results against raw imaging data and their clinical expertise to ensure accuracy and patient safety. The user manual emphasizes the importance of qualified operators and the software's limitations in clinical decision-making.
Several other platforms offer AI-driven cardiovascular imaging analysis, such as solutions from vendors like GE HealthCare, Siemens Healthineers, and Arterys MICA. 3mensio is often recognized for its specialized focus on structural heart and vascular interventions, offering deep, procedure-specific AI tools for planning procedures like TAVI, TEVAR, and EVAR.
Pricing for AI features in 3mensio Workstation can vary, often bundled with software licenses or offered as modular add-ons, sometimes with subscription models. The expected return on investment comes from increased efficiency in planning, reduced procedure times, and potentially improved patient outcomes due to more precise pre-procedural assessment.
3mensio Workstation is designed for integration with existing PACS and EMR systems, typically using standard protocols like DICOM for image transfer. It can run on modern desktop computers with specific hardware configurations, including a suitable CPU, SSD, RAM, and GPU, and supports Windows 10 and 11 operating systems.
Comprehensive training is typically provided by the vendor, including in-person training, web-ex sessions, and e-learning through the PMI Academy, which offers 24/7 accessibility and self-paced modules. Ongoing technical support and clinical application specialists are also usually available to assist with any questions or issues that arise during use.

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