Brainlab Elements BOLD MRI Mapping (1.0)

by Brainlab  · Based in Germany → — Innovating Medtech for Better Patient Outcomes
Neurology Neurosurgery Radiology

Regulatory Status Disclosed

Overview

Brainlab Elements BOLD MRI Mapping (1.0) is a specialized software application within the Brainlab Elements suite, designed to process and visualize Blood Oxygen Level Dependent (BOLD) functional MRI (fMRI) data. This tool allows medical professionals to generate functional maps that highlight perceptual, motoric, and cognitive areas of the brain. It plays a crucial role in enhancing anatomical images with functional information, which is vital for refining surgical approaches and improving patient outcomes in cranial procedures. The software is indicated for planning cranial surgical treatments and supports the alignment and manipulation of medical images through features like visualization of blood oxygen level data. It is not intended for diagnostic purposes but rather to aid in surgical intervention and treatment planning. The Brainlab Elements suite, including BOLD MRI Mapping, aims to streamline pre-planning workflows and bridge various clinical subspecialties such as neurosurgery and radiation oncology.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Analysis of Blood Oxygen Level Dependent (BOLD) MRI data
  • Visualization of brain activation signals and functional maps (perceptual, motoric, cognitive areas)
  • Integration with image-guided surgery systems
  • Support for cranial surgical treatment planning
  • Fusion with other imaging modalities (e.g., DTI, anatomical MRI)
  • Interactive selection and display of functional areas and regions of interest
  • Conversion of functional areas into 3D objects for navigation
  • Automated import of DICOM BOLD MRI data
  • Automatic detection of functional activations
  • Conjunction display for enhanced sensitivity in mapping crucial areas (e.g., language)

Use Cases

  • Pre-surgical planning for neurosurgery (e.g., brain tumors, AVMs, cortical dysplasias)
  • Mapping of eloquent brain areas (motor, sensory, language) to avoid functional deficits during surgery
  • Functional neurosurgery planning (e.g., for movement disorders, drug-resistant epilepsy)
  • Radiotherapy treatment planning (as part of the broader Elements suite)
  • Improving surgical approaches and patient outcomes in cranial procedures
  • Assisting in the interpretation and manipulation of medical image data for treatment planning

What Physicians Need to Know

Brain MRI Analysis
Brainlab Elements BOLD MRI Mapping (1.0) analyzes task-based blood oxygen level dependent (BOLD) MRI data to visualize activation signals in the brain. It re-implements existing tools and functionality for functional planning, including denoising, brain mask filtering, spatial smoothing, and motion correction. It can optionally use distortion correction from Brainlab Elements Image Fusion. The software is designed to process medical image data to support image-guided surgery and radiation treatment planning, offering modules for 2D & 3D image viewing, image processing, image co-registration, image segmentation, and 3D visualization. It also supports the visualization and analysis of brain white matter pathways using constrained spherical deconvolution (CSD) analysis and Diffusion Tensor Imaging (DTI)-based tractography for enhanced neurological understanding and patient care. This allows for patient-specific planning by integrating combined MRI and DWI data, and offers tracking templates for efficient and reproducible tracking of white matter tracts.
Mobile Notification System
Brainlab Elements supports collaboration across departments and locations, with compatibility for mobile devices and workstations, ensuring flexibility and accessibility for clinicians. It offers the freedom to work online on preferred devices, including iPad and iPhone, or offline on a workstation.
Physician Tip

Brainlab Elements BOLD MRI Mapping (1.0) is a powerful tool for functional neurosurgery, enabling precise localization of brain structures and visualization of activation signals. Leverage its advanced processing capabilities, including denoising and motion correction, to obtain high-quality functional maps. Utilize the Fibertracking module with CSD-based tractography for more accurate visualization of white matter pathways, which is critical for surgical planning to avoid damage to vital areas. The ability to integrate combined MRI and DWI data allows for highly patient-tailored planning. The mobile compatibility of the Brainlab Elements suite facilitates flexible planning and review, even for busy clinicians, and supports collaboration across different locations. For deep brain stimulation (DBS) procedures, the reliable fusion of MR and CT images, along with anatomical structure molding, assists in making informed judgments about DBS contact locations. The system's automatic image registration capabilities, especially with intraoperative MRI, can help compensate for brain shift during surgery, maintaining navigation accuracy and allowing for instant resection verification.

Brainlab Elements BOLD MRI Mapping (1.0) is part of the broader Brainlab Elements suite, which is designed for seamless integration within clinical workflows. It integrates with other Brainlab Elements modules such as Image Fusion and Fibertracking. The suite is compatible with platforms like Curve™ Image Guided Surgery and Buzz® Digital O.R. for enhanced workflow efficiency. It supports automatic registration with intraoperative MRI (iMRI) and other imaging devices like iCT, rotational angiographs, and cone-beam CT, ensuring seamless integration with image-guided surgery. The system also integrates with the Boston Scientific DBS portfolio for advanced deep brain stimulation workflows, offering customized 3D lead geometry visualization and automated lead detection. Data handling and documentation are facilitated through direct HIS and PACS connections. The open platform philosophy of Brainlab aims to connect every step of the treatment pathway and bridge existing gaps, allowing for integration of various technologies.

Details

Category Neurology AI, Radiology & Imaging AI, Surgical AI
Pricing Unknown
DeploymentOn-premise, Cloud
Mobile AppYes
Data Export Yes
Training Yes
Compliance
BAA Available Yes AI-estimated
HIPAA Compliant Yes AI-estimated
FDA Status Cleared AI-estimated
SOC 2 Yes AI-estimated
GDPR Yes AI-estimated
Integrations
EHR Not specified
Specialties Neurology, Neurosurgery, Radiology

Support & Reliability

Training Provided Yes

What the Web Says

Brainlab Elements BOLD MRI Mapping (1.0) is a software application designed to analyze task-based blood oxygen level dependent (BOLD) MRI data to visualize brain activation signals. It is part of the broader Brainlab Elements suite, which offers various pre-planning solutions for radiotherapy and surgery, aiming to enhance planning accuracy and efficiency. The software is intended for use by medical professionals to process image data for surgical interventions and treatment planning, particularly in neurosurgery for mapping critical brain functions like language and motor areas prior to surgery.

Overall: Positive

Strengths

  • Enhances anatomical MRI images with functional maps, highlighting critical brain areas.
  • Aids in pre-surgical planning by mapping brain activity, helping to avoid damage to vital functions during procedures.
  • Provides tools to analyze task-based BOLD MRI data to visualize activation signals.
  • Integrates with other Brainlab platforms like Curve™ Image Guided Surgery and Buzz® Digital O.R. for optimized utilization.
  • Streamlines pre-planning workflow with intuitive modules.
  • Can significantly reduce planning time, making advanced treatments more accessible.

Limitations

  • Requires specific hardware criteria and trained personnel for effective operation.
  • AI features are dependent on the quality of input images and user-defined parameters.
  • Not intended for direct diagnosis or creating physical replicas from image data for diagnostic purposes.
  • Interpretation of fMRI results can be complicated by neurovascular uncoupling in patients with existing brain pathology.
  • Previous Brainlab cranial navigation systems (pre-version 3.0) faced recalls due to inaccuracies in real-time display.
  • Mapping multiple functional domains with task-based fMRI can be time-consuming.

Based on reviews from: medicalexpo.com, nih.gov, capterra.com, lensa.com, fda.gov, medicalnewsobserver.com, youtube.com, innolitics.com, brainlab.com, learnneuroradiology.com, researchgate.net, slideshare.net, searcylaw.com, g2.com

Last updated: 2026-10-29

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Press & Coverage

fda.gov
Brainlab Elements BOLD MRI Mapping (1.0) 510(k) Premarket Notification
Brainlab Elements BOLD MRI Mapping (1.0) received 510(k) clearance from the FDA on July 14, 2023, as part of the Brainlab Elements suite, which includes software for processing medical image data to support image-guided surgery and radiation treatment planning.
2023-07
fda.gov
Brainlab Elements (7.0); Brainlab Elements Image Fusion (5.0); Brainlab Elements Image Fusion Angio (1.0); Brainlab Elements Contouring (5.0); Brainlab Elements Fibertracking (3.0); Brainlab Elements BOLD MRI Mapping (1.0)
This FDA 510(k) premarket notification, with a decision date of June 13, 2025, lists Brainlab Elements BOLD MRI Mapping (1.0) as part of an updated Brainlab Elements suite (version 7.0).
2025-06
slideshare.net
iPlan BOLD MRI Mapping Clinical White Paper
This clinical white paper discusses iPlan BOLD MRI Mapping, which enhances anatomical MRI images with functional maps to highlight brain areas critical for motoric and cognitive functions, detailing the technical processes for data import, preprocessing, and statistical analysis.
unknown
medicalnewsobserver.com
Brainlab Elements Suite: Transforming Healthcare with Software-Based Technology
This article from April 2024 highlights the Brainlab Elements suite, including BOLD MRI Mapping (1.0), as a software-based technology that transforms healthcare by providing tools for contouring, image fusion, and visualization of neurological and vascular structures for pre-surgical planning and radiotherapy.
2024-04
youtube.com
Brainlab Elements: Software Transforming Modern Medicine | The Future of Surgical Precision
A video from November 2025 discusses Brainlab Elements as a groundbreaking suite of medical software that redefines how surgeons plan and operate by converting 2D medical scans into interactive 3D anatomical maps, aiding in cranial planning and fibertracking.
2025-11
brainlab.com
Clinical Literature Library
Brainlab's clinical literature library, updated in October 2026, lists several publications that reference Brainlab Elements BOLD MRI Mapping, often in the context of surgical planning and neuroimaging.
2026-10
brainlab.com
Brainlab Press Releases
Brainlab's press release section, last updated in September 2026, provides a chronological list of company news, though specific mentions of 'Elements BOLD MRI Mapping (1.0)' are not immediately apparent in the provided snippets.
2026-09
learnneuroradiology.com
BOLD fMRI for Language Localization
This article from June 2019 explains BOLD fMRI as an advanced MRI technique used to map brain activation during specific tasks, particularly for language localization in surgical planning, and mentions Brainlab as one of the processing suites for fMRI data.
2019-06

Videos

Product demos, reviews, and walkthroughs for Brainlab Elements BOLD MRI Mapping (1.0).

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Frequently Asked Questions

Brainlab Elements BOLD MRI Mapping (1.0) is a software application that analyzes task-based blood oxygen level dependent (BOLD) MRI data to visualize activation signals in the brain. This tool is used in neurology for functional planning, particularly for mapping language areas to help avoid critical regions during complex surgical procedures. It processes fMRI data, which measures changes in blood oxygenation to identify activated brain regions during specific tasks.
While Brainlab Elements BOLD MRI Mapping (1.0) utilizes advanced features, its effectiveness relies on proper hardware and user expertise. The AI's performance is highly dependent on the quality of the input images and the parameters set by the user. It's crucial for clinicians to verify AI-generated plans and segmentations, as these tools are intended to assist, not replace, independent surgical judgment.
Brainlab Elements BOLD MRI Mapping (1.0) is part of the Brainlab Elements suite, which has received 510(k) premarket notification clearance from the FDA. This indicates that the device has demonstrated substantial equivalence to a legally marketed predicate device. The software is intended for processing medical image data to support image-guided surgery and radiation treatment planning.
Yes, there are other processing suites available for fMRI data. While Brainlab is a prominent option, other software packages exist, and the general principles of fMRI data processing remain similar across different platforms. Some examples of general medical imaging software that offer advanced visualization and processing capabilities include 3D Slicer, Materialise Mimics, and Fujifilm's Synapse 3D.
BOLD fMRI, in general, has several limitations. These include susceptibility to geometric distortions, especially with EPI sequences, and the potential for venous effects where hemodynamic changes can propagate to large draining veins, leading to uncertainty in localizing neural activity. Signal loss in certain brain regions and the challenge of interpreting results due to noise and the high number of images can also be limitations. The software's AI features are also dependent on input image quality and user-defined parameters.

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Suggest an Edit → | Report an issue | Last Verified: 2026-04-17 | First Added: 2026-04-17
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