Brainlab Elements Image Fusion (5.0)
Regulatory Status Disclosed
Overview
Brainlab Elements Image Fusion (5.0) is a sophisticated software application within the Brainlab Elements suite, designed for the co-registration and alignment of various medical image data sets. It utilizes rigid and deformable registration methods to accurately align anatomical structures, providing clinicians with enhanced insights for treatment planning. [13, 15, 21] This tool is integral to both cranial and extracranial surgical and radiotherapy planning, enabling the fusion of different image modalities such as MRA, CTA, DSA, MRI, and intraoperative CT (iCT). [13, 15, 16, 21, 24]
The software facilitates the integration of preoperative planning data into intraoperative scenarios, supporting precise navigation and visualization of patient anatomy. [16] It allows for region-of-interest definition for targeted data correlation and offers flexibility in contouring on various datasets. [25, 30] While not intended for diagnostic purposes, Brainlab Elements Image Fusion 5.0 plays a crucial role in improving the accuracy and consistency of medical treatments by providing a comprehensive and integrated view of patient data. [15, 21]
Reviewed by Pouyan Golshani, MD — Interventional Radiologist
Key Features
- Fully automated and highly accurate image fusion
- Rigid and deformable registration methods
- Co-registration of multiple image modalities (MRA, CTA, DSA, MRI, iCT)
- Region-of-interest (ROI) definition for targeted correlation
- Flexibility to contour on any datasets
- Integration with other Brainlab Elements modules (e.g., Contouring, Fibertracking, BOLD MRI Mapping)
- Support for intraoperative image updates (e.g., Ultrasound Snap to MRI)
- Advanced 2D and 3D visualization
- AI features for identification of previously diagnosed lesions or tumors (in Elements Image Fusion Angio, part of the cleared suite)
- Streamlined pre-planning workflow
Use Cases
- Cranial and extracranial surgical planning
- Pre-planning for radiotherapy treatments
- Functional neurosurgery (e.g., Deep Brain Stimulation, sEEG, biopsies)
- Intraoperative navigation updates with real-time imaging
- Spine surgery planning and navigation
- Pre-planning for tumor resection and assessment
What Physicians Need to Know
Key Capabilities
Brainlab Elements Image Fusion (5.0) is an application designed for the co-registration of image data within medical procedures, utilizing both rigid and deformable registration methods. It aims to align anatomical structures between different datasets. The software offers fully automated and highly accurate image fusion, employing a mutual information algorithm for rapid dataset correlation. It also allows for region-of-interest definition for dataset correlation on areas with similar anatomy and provides flexibility to contour on any datasets. The tool is part of the broader Brainlab Elements suite, which transforms 2D medical scans into interactive 3D anatomical maps for precise navigation. It can fuse various imaging modalities such as CT, MRI, PET, SPECT, and US. The software also includes features for 2D & 3D image viewing, image processing, image co-registration, image segmentation, and 3D visualization of medical image data for treatment planning. It can be used to visualize the skull base and tumor margins clearly, and color display of different datasets helps distinguish tumors and the skull base. The fused CT data in bone window mode provides additional information on the osseous skull base. The software also supports automated rigid fusion between preoperative MRI and intraoperative ultrasound images, allowing surgeons to update registration and navigate on updated patient anatomy.
Clinical Utility
Brainlab Elements Image Fusion (5.0) is indicated for processing medical image data to support image-guided surgery and radiation treatment planning. It enhances anatomical insights for vital definition and contouring throughout the body, streamlining pre-planning workflows. The software is used in various clinical subspecialties, including neurosurgery, spine surgery, orthopedics, and radiation oncology. It aids in pre-surgical planning and radiotherapy by providing accurate image correlation and contouring capabilities. The image fusion process can take as little as 5 minutes prior to surgery. The software's ability to fuse different imaging modalities helps in visualizing complex anatomical structures and pathologies, such as skull base tumors. It also supports advanced applications like functional neurosurgery by leveraging advanced imaging for deep brain stimulation procedures, from planning to intraoperative targeting and postoperative assessment.
Integration Options
Brainlab Elements Image Fusion (5.0) is available as an individual application for easy integration into clinical workflows. It is designed to integrate seamlessly with other Brainlab platforms, such as Curve™ Image Guided Surgery and Buzz® Digital O.R., to enhance workflow efficiency and reduce potential errors. The software supports collaboration across departments and locations, with compatibility for mobile devices and workstations, offering flexibility and accessibility for clinicians. It can transfer DICOM data to and from Picture Archiving and Communication Systems (PACS) and other storage media devices.
Compliance Status
Brainlab Elements Image Fusion (5.0) has received FDA 510(k) clearance. It is a medical device that meets safety and performance requirements. Brainlab is committed to high ethical standards and has an Integrity & Compliance Program to address legal requirements and support internal guidelines.
Pricing Model
Brainlab offers flexible business models for its Elements suite, ranging from simple, single licenses to multiple offerings across various departments. This allows facilities to access and utilize Elements according to their specific needs and evolving requirements.
User Experience
The Brainlab Elements suite is described as user-friendly, providing an intuitive interface with modules that streamline pre-planning workflows. It offers flexibility for clinicians to work online on preferred devices, including iPads and iPhones, or offline on a workstation. The software is designed for easy setup and usage on any device, allowing full software functionality.
Support Quality
Brainlab provides comprehensive service and support, including professional project management, healthcare IT, and third-party integration, to ensure seamless integration and smooth operation of its solutions. They offer tailored support for their technology, including services for surgery, radiosurgery, and digital O.R.s. Education and training tools are also available to help users maximize their Brainlab solutions.
Implementation Complexity
The Brainlab Elements suite is designed to be easily integrated into clinical workflows. While the software is powerful and flexible, its effective operation depends on proper hardware and user expertise. Brainlab provides support for implementation and training to ensure smooth integration and usage.
Evidence Base
Clinical validation of Brainlab Elements has demonstrated its effectiveness in pre-planning for surgeries and radiotherapy. Studies have evaluated the accuracy of image fusion methods, including semi-elastic fusion, showing high precision in landmark accuracy. Research has also been conducted on the accuracy of dose calculation algorithms within the Brainlab Elements planning system. The software meets safety and performance requirements, with verification processes ensuring it performs as intended and risk management measures in place.
Physician Tip
Leverage the automated co-registration for enhanced anatomical insights and efficient contouring across various body regions. Utilize the flexibility to contour on any dataset, which can be particularly beneficial for complex cases. Explore the mobile device compatibility for planning and reviewing, enabling greater flexibility in your workflow. For spinal surgeries, consider the benefits of semi-elastic fusion for improved accuracy, especially in the lumbar area, as it can be more precise than rigid fusion and more efficient for multi-segmental screw placement.
Brainlab Elements Image Fusion (5.0) is designed for easy integration into existing clinical workflows and seamlessly connects with other Brainlab platforms like Curve™ Image Guided Surgery and Buzz® Digital O.R. It supports DICOM data transfer to and from PACS and other storage media, facilitating a connected and efficient digital ecosystem within the hospital. The software also integrates with Fujifilm's ARIETTA Precision for streamlined system setup in cranial imaging.
Details
| Category | Oncology AI, Radiology & Imaging AI, Surgical AI |
| Pricing | Unknown |
| Deployment | On-premise and cloud-based options are available. Brainlab Elements can be used online on various devices, including iPad and iPhone, or offline on a workstation. |
| Mobile App | Yes |
| API Available | Yes |
| Training | Yes |
| Compliance | |
| BAA Available | Yes AI-estimated |
| HIPAA Compliant | Yes AI-estimated |
| FDA Status | Cleared AI-estimated |
| Integrations | |
| EHR | Not specified |
| Specialties | Neurosurgery, Oncology, Radiology |
Support & Reliability
| Training Provided | Yes |
What the Web Says
Brainlab Elements Image Fusion (5.0) is a software application designed for co-registration of medical image data using rigid and deformable registration methods, aiming to align anatomical structures between different datasets. It is part of the broader Brainlab Elements suite, which provides various tools for image-guided surgery and radiation treatment planning. The software is praised for its accuracy and reliability in multi-modality image fusion, offering physicians enhanced anatomical insights for contouring and definition.
Overall: PositiveStrengths
- Automated and accurate image fusion for precise dataset correlation and contouring.
- Enhances anatomical insights for vital definition and contouring.
- Supports multi-platform flexibility, allowing access on various devices including mobile.
- Streamlines pre-planning workflow in radiotherapy.
- Integrates seamlessly with other Brainlab platforms like Curve™ Image Guided Surgery and Buzz® Digital O.R.
- Offers customizable solutions for diverse departmental needs and scalable business models.
Limitations
- Dependency on proper hardware and user expertise for effective operation.
- AI features rely heavily on input image quality and user-set parameters.
- No specific contraindications, but usage is limited to interpretation and manipulation of image data, not direct diagnosis.
- Limited information available from independent tech reviewers, G2, Capterra, and Reddit specifically for version 5.0 of Image Fusion.
Based on reviews from: frontiersin.org, capterra.com, youtube.com, slashdot.org, innolitics.com, medicalnewsobserver.com, gitnux.org, medicalexpo.com, fda.gov, brainlab.com, slideshare.net, g2.com, reddit.com
Last updated: 2026-10-29
Ratings & Reviews
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Press & Coverage
appliedradiology.com
FUJIFILM Healthcare Americas Corporation and Brainlab Announce Collaboration to Enhance Neurosurgical Workflows
Brainlab is collaborating with FUJIFILM Healthcare Americas Corporation to be the exclusive U.S. distributor of ARIETTA Precision Ultrasound for neurosurgery, integrating with Brainlab's surgical navigation systems. This collaboration includes the use of Elements 'Ultrasound Snap to MRI' software, also known as Brainlab Elements Image Fusion, for automated rigid fusion between preoperative MRI and intraoperative ultrasound images, allowing surgeons to navigate on updated patient anatomy.
2024-04
fda.gov
Brainlab Elements Image Fusion, Contouring (4.5);Image Fusion (4.5);Fibertracking (2.0);BOLD MRI Mapping (1.0);Image Fusion Angio (1.0)
The FDA granted 510(k) clearance to Brainlab Elements Image Fusion, Contouring (4.5); Image Fusion (4.5); Fibertracking (2.0); BOLD MRI Mapping (1.0); Image Fusion Angio (1.0) on July 14, 2023. This regulatory announcement details the clearance of Brainlab Elements 6.0, which includes Image Fusion as an application for co-registration of medical image data using rigid and deformable registration methods.
2023-07
youtube.com
Brainlab Elements: Software Transforming Modern Medicine | The Future of Surgical Precision
This video highlights Brainlab Elements as a suite of medical software that converts 2D medical scans into interactive 3D anatomical maps, providing GPS-like precision for surgeons. It emphasizes how the software, including modules like Fibertracking, enhances accuracy and safety in the operating room by visualizing critical structures and neural pathways.
2025-11
medicalnewsobserver.com
Brainlab Elements 6.0: Advancing Image-Guided Surgery and Radiotherapy
Brainlab Elements 6.0, which includes Brainlab Elements Image Fusion, is a software suite designed to process medical image data for image-guided surgery and radiation treatment planning. It offers tools for contouring, image fusion, and visualization, demonstrating compliance with safety and performance standards.
2024-04
brainlab.com
Elements Spine Planning now FDA 510(k) cleared | Brainlab
Brainlab announced that Elements Spine Planning, a component of the Elements suite, received FDA 510(k) clearance. This software assists clinicians in analyzing patient-specific spinopelvic parameters and planning sagittal alignment of the spine, utilizing AI algorithms for routine planning steps.
2026-10
novaliscircle.org
Elements AI Tumor Segmentation is now live in clinical use
Brainlab has integrated AI Tumor Segmentation into its Elements software, which is now live in clinical use. This advancement aims to enhance multiple brain metastases and retreatment review workflows in radiosurgery.
2025-07
medicalexpo.com
Brainlab Elements
Brainlab Elements offers a suite of radiotherapy pre-planning solutions that streamline the planning process for clinicians across various clinical subspecialties. Key features include automated, accurate image fusion for precise dataset correlation and contouring, as well as advanced 3D visualization.
unknown
frontiersin.org
Brainlab Elements' Monte Carlo dose calculation algorithm provides reliable accuracy across clinically relevant heterogenous and small field conditions
This peer-reviewed article evaluates the Monte Carlo and pencil beam dose calculation algorithms within Brainlab Elements Treatment Planning System (TPS) using a reference beam model. The study concludes that Brainlab Elements' Monte Carlo dose calculation algorithm provides reliable accuracy for stereotactic radiosurgery.
unknown
Videos
Product demos, reviews, and walkthroughs for Brainlab Elements Image Fusion (5.0).
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Frequently Asked Questions
Brainlab Elements Image Fusion (5.0) uses AI for automated, accurate image fusion, which is crucial for precise dataset correlation and contouring in radiotherapy planning. This helps streamline the pre-planning workflow by transforming image preprocessing into actionable treatment plans. While the Image Fusion module itself focuses on automated co-registration, other Brainlab Elements modules, like Elements AI Tumor Segmentation, directly integrate AI for tasks such as segmenting supported cranial tumors, enhancing workflows for multiple brain metastases and retreatment review.
Brainlab Elements Image Fusion (5.0) is part of the broader Brainlab Elements suite, which is intended for radiation treatment planning and image-guided surgery. The software is subject to regulatory requirements, including FDA 510(k) clearance, and must comply with the Unique Device Identification System (UDI) Rule. The suite demonstrates compliance with safety and performance standards, with verification processes in place to ensure it performs as intended and mitigates potential risks.
A primary limitation of the Brainlab Elements suite, including Image Fusion, is its dependency on proper hardware and user expertise. Effective operation requires a computing environment that meets specific hardware criteria and trained personnel to correctly interpret and utilize the processed images. Additionally, while advanced, the software's AI features are heavily reliant on the quality of the input images and the parameters set by the user.
Several alternatives exist for oncology image processing. Some examples include other modules within the Brainlab Elements suite like Elements Cranial SRS and Elements Multiple Brain Metastases SRS, which offer advanced features for specific oncology planning. Other software solutions in the market that provide 3D modeling, image processing, and visualization capabilities for medical images include 3D-DOCTOR, OsiriX, Elucis, Synapse 3D, Materialise Mimics, and Fovia's XStream HDVR SDK Suite.
Brainlab Elements Image Fusion (5.0) is designed for seamless integration within clinical workflows, supporting collaboration across departments and locations. It is compatible with mobile devices and workstations, and integrates with platforms like Curve™ Image Guided Surgery and Buzz® Digital O.R. The software also processes and transfers DICOM data to and from PACS and other storage media devices, facilitating comprehensive treatment planning.
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| Last Verified: 2026-04-17 | First Added: 2026-04-17