Ansys Simpleware Medical
Clinical Image Processing

FDA 510(k) cleared and CE marked 3D image processing software that converts medical scan data into accurate, patient-specific models to support clinical decision-making.

Overview
Capabilities

CLINICAL IMAGING

Ansys Simpleware Medical Improves Clinical Decision-Making Through Accurate Models

Ansys Simpleware Medical provides a complete image-to-simulation workflow for clinical applications. Transform CT and MRI data into reliable 3D models for pre-surgical planning, patient-specific device design inputs, and anatomical analysis. Regulatory-ready workflows integrate directly with design, simulation, and medical 3D printing environments.

Import DICOM data directly from PACS
Process 3D and 4D medical imaging
Analyze and measure anatomies accurately
Improve surgical planning with reliable models
Comply with patient data privacy standards
Cutting-edge automation and advanced segmentation

Quick Specs

Simpleware Medical delivers comprehensive tools for segmentation, meshing, measurement, and 3D printing from medical imaging data. Automate workflows, ensure regulatory compliance, and export simulation-ready models with confidence.

DICOM Import

Advanced Meshing Tools

3D Printing Export

ISO 13485 Certified

3D/4D Visualization

Anatomical Measurements

FDA 510(k) Cleared

Cleared as a medical device in Australia and Japan

AI-Driven Segmentation*

CAD Integration

CE Marked

Python API Scripting

*Not part of the regulatory clearance

Applications

View All Ansys Applications

Cardiovascular

Create validated, multiphysics models of the heart, cardiac devices, and drug interactions, to design, optimize, and test safe cardiovascular treatments.

Learn More

Orthopedic

Develop innovative, durable orthopedic implants using validated multiphysics models of tissues, materials, patient-specific physiology, surgical procedures, and manufacturing processes.

Learn More

CLINICAL WORKFLOWS

Complete Medical Image Processing for Patient-Specific Modeling

Simpleware Medical enables engineers and clinical teams to create accurate, simulation-ready models from CT and MRI data through structured, automated workflows. Segmentation, automation, and industry-leading meshing capabilities reduce manual effort while improving consistency and reproducibility. Regulatory-ready processes support FDA 510(k), EEA CE marking requirements, and medical device workflows in Australia and Japan. Seamlessly integrate imaging, design, and simulation into a unified environment for faster insights and improved collaboration.

Key Features

Simpleware Medical delivers end-to-end capabilities from image import to patient-specific, clinically actionable model generation.

Patient-Specific Surgical Planning
Point-of-Care 3D Printing
Regulatory Compliance
Complete Image Processing Toolkit
AI Segmentation and Landmarking*
Image-to-Simulation Workflow
Scripting and Automation

Patient-Specific Surgical Planning

Improve confidence in clinical decision-making by generating 3D models from imaging data to visualize patient anatomies, perform measurements, and help plan surgical treatments.

Generate models from 3D image data to improve understanding of individual patient anatomies
Perform measurements on anatomical data to review surgical treatment options
Improve confidence in pre-surgical plans with patient-specific 3D models
Export models for further analysis in simulation and design environments
Improve clinical training and patient communication through patient-specific 3D models

Complete Image Processing Toolkit

Visualize and segment anatomies, perform advanced analyses using extensive measurement and statistics tools, and improve confidence through reliable anatomical models.

Easy-to-use intuitive interface with quick-and-easy access to all tools and features
Take advantage of exclusive features designed specifically for clinical applications
Streamline software resources with a complete medical image processing platform
Comply with privacy standards for handling patient data
Comprehensive tutorials, integrated help, and expert technical support
Customize workflows with fully documented API and macro recording functionality
Build scripts with Python, C#, and Java

AI Segmentation and Landmarking

Reduce manual effort and improve consistency for non-clinical applications with fully automated AI-based machine learning for anatomical segmentation and landmarking across multiple modalities.

Ankle CT segmentation and landmarking
Aorta CT segmentation and landmarking
CMF CT segmentation and landmarking
Heart CT segmentation and landmarking
Heart valve analysis
Hip CT segmentation and landmarking
Hip revision CT segmentation and landmarking
Knee CT segmentation and landmarking
Knee MRI segmentation and landmarking (including cartilage)
Shoulder CT segmentation and landmarking
Spine CT segmentation

Image-to-Simulation Workflow

Generate simulation-ready meshes directly from imaging data with conforming multi-part volume meshes, feature-based refinement, and native exports for major solvers.

Conforming multi-part volume meshes
Feature-based and user-defined mesh refinement
Per-part meshing controls
Define contacts and node sets
Hounsfield material mapping for FE exports
Boundary layer meshing
Dedicated native exports for all major solvers
Optimize element qualities against a choice of metrics
Import existing meshes and assign material properties
Segmentation checker to identify and fix problematic regions before meshing
Mesh quality histogram to inspect generated meshes

Regulatory Compliance

Simpleware Medical comes with FDA 510(k) clearance, CE marking, Australian and Japanese medical device clearances, and ISO 13485:2016 certification, ensuring traceable, reproducible workflows for clinical use.

Developed for biomedical engineers to inform clinical management
Speed up compliance processes by integrating certified software into your workflows
Trust in software that has gone through rigorous compliance processes
Use Simpleware Medical as a software interface and image segmentation system for medical imaging information transfer
Comply with privacy standards for handling patient data

Point-of-Care 3D Printing

Print accurate, patient-specific anatomical models to practice and help plan surgical procedures, improving anatomical understanding with realistic physical models.

Print accurate, patient-specific models to practice and review surgical procedures
Improve anatomical understanding with realistic physical models
Range of tools for preparing and reviewing models before export to 3D printing
Use 3D printed models for communication, training, and to inform diagnostic decisions
FDA-cleared for end-to-end diagnostic 3D printing with compatible printers

Scripting and Automation

Simpleware allows users to create the automates workflows through user driven macros, scripting and plug-ins through to customised end to end solutions. Incorporate image processing, landmarking, measurements and statistics, report generation, model generation and more…

Reduce manual input, freeing up engineering time
Efficiently process large numbes of datasets
Ensure consistent, repeatable results for repeated workflows
Convert expert, specialisist knowledge into usable tools
Customisable interface
Fully documented API supports macro recording, scipting and plug-in creating with Python and C#
Batch processing through command line

Ansys software is accessible

It's vital to Ansys that all users, including those with disabilities, can access our products. As such, we endeavor to follow accessibility requirements based on the US Access Board (Section 508), Web Content Accessibility Guidelines (WCAG), and the current format of the Voluntary Product Accessibility Template (VPAT).

View VPAT Reports

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Ansys Simpleware Medical Clinical Image Processing