Brainlab Elements BOLD MRI Mapping (1.0)

by Brainlab AG  · Based in Germany →Advanced functional brain mapping for neurosurgical precision.
Neurology Neurosurgery Radiology

Contact for pricing
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/CT Analysis
Analyzes task-based Blood Oxygen Level Dependent (BOLD) MRI data to visualize activation signals and correlations between brain areas, converting 2D scans into interactive 3D anatomical maps for surgical planning.
Epilepsy Planning Support
Utilizes BOLD MRI mapping to create detailed 3D brain maps, aiding in the localization of seizure foci for precise surgical planning in epilepsy cases.
AI-Powered Anomaly Detection
Leverages machine learning algorithms for anomaly detection and atlas-based automatic segmentation within the broader Brainlab Elements suite, enhancing image processing for planning.
Mobile Access for Review
Part of the Brainlab Elements suite, supporting clinicians with multi-platform flexibility, allowing planning and review on preferred devices including iPad and iPhone.
Physician Tip

Brainlab Elements BOLD MRI Mapping (1.0) is a powerful tool for functional neurosurgical planning, enabling visualization of eloquent brain areas. Physicians should note that this tool is specifically for *planning* and *not intended for diagnostic purposes*. It enhances the understanding of brain function in relation to surgical targets, particularly useful in cases like tumor resection near critical areas or epilepsy surgery. Integrating BOLD MRI data with other imaging modalities through the Elements suite provides a comprehensive view for patient-specific treatment strategies. Always correlate the software's output with clinical findings and other diagnostic information.

Brainlab Elements BOLD MRI Mapping (1.0) is a core module within the Brainlab Elements software suite, designed for seamless integration with other Brainlab applications such as Contouring, Image Fusion, and Fibertracking. This allows for a unified workflow from image processing and segmentation to advanced visualization and surgical planning. The suite supports DICOM data transfer and is built for interoperability within medical imaging environments, facilitating comprehensive pre-operative planning and intraoperative guidance. Future integrations are expected to further leverage AI and cloud computing for enhanced collaboration and automated features.

Details

Category Neurology AI, Radiology & Imaging AI, Surgical AI
Pricing Contact for pricing
  • Pricing is not publicly disclosed and is typically provided through direct consultation with Brainlab sales representatives
DeploymentOn-premise (workstation), Cloud-based, Mobile (iOS for review/planning)
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

Brainlab Elements BOLD MRI Mapping (1.0) is part of the Brainlab Elements suite, which has received FDA 510(k) clearance (K243633, K223106). It is indicated for planning cranial surgical treatments and provides tools to analyze BOLD MRI data to visualize activation signals, but it is not intended for diagnostic purposes.

Integrations
EHR Not specified
Specialties Neurology, Neurosurgery, Radiology

What the Web Says

Brainlab Elements BOLD MRI Mapping 1.0 is a software application designed for neurosurgical planning, specifically to analyze blood oxygen level dependent (BOLD) MRI data. It helps visualize activation signals and correlations between brain areas, aiding in the planning of cranial surgical treatments. The software is part of the broader Brainlab Elements suite, which provides a comprehensive set of tools for image-guided surgery and radiation treatment planning, converting 2D scans into interactive 3D anatomical maps.

Overall: Positive

Strengths

  • Provides tools to analyze BOLD MRI data to visualize activation signals and correlations between brain areas.
  • Aids in planning cranial surgical treatments by enhancing anatomical images with functional maps.
  • Offers an intuitive user interface for easy display and selection of functional areas and regions of interest.
  • Can be fused with other imaging modalities for comprehensive functional planning.
  • Part of a robust suite of tools that enhance accuracy, safety, and confidence in the operating room.
  • Helps surgeons map out the safest possible route to a tumor and visualize critical brain structures and neural pathways.

Limitations

  • Not intended for diagnostic purposes.
  • Requires proper hardware and user expertise for effective operation.
  • AI features depend heavily on input image quality and user-defined parameters.
  • The interpretation of BOLD signals can be complex, and some research challenges the canonical interpretation, indicating potential limitations in directly inferring neuronal activity.
  • The software itself does not have clinical indications, as it is a planning tool.
  • Older versions of the broader Brainlab Elements suite sometimes required manual iterations for optimal planning, though newer versions have improved automation.

Based on reviews from: FDA Radiology AI Device, Medical News Observer, AccessGUDID, accessdata.fda.gov, Brainlab Elements: The Software Revolutionizing Modern Surgery - YouTube, Functional Neurosurgery Planning Solutions - Brainlab, iPlanu00ae BOLD MRI Mapping - AADEE, Elements Fibertracking - Brainlab, Advancing technology for clinicians and patients - Brainlab, Evaluation of the ability of the Brainlab Elements Cranial Distortion Correction algorithm to correct clinically relevant MRI distortions for cranial SRT - PubMed, Elements - Brainlab - PDF Catalogs | Technical Documentation, How does the fMRI measure BOLD signals? : r/Neuropsychology - Reddit, BOLD signal changes can oppose oxygen metabolism across the human cortex - Reddit, Dosimetric Evaluation and Comparison of Brainlab Elements Version 2.0 and 3.0, r/neuroimaging - Reddit, Functional MRI (fMRI) Brainlab Processing Guide - YouTube, Use of virtual magnetic resonance imaging to compensate for brain shift during image-guided surgery: illustrative case - PMC

Last updated: 2026-07-17

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Press & Coverage

RadAI Slice
Brainlab Elements Image Fusion, Contouring (4.5);Image Fusion (4.5);Fibertracking (2.0);BOLD MRI Mapping (1.0);Image Fusion Angio (1.0) | FDA Radiology AI Device
Brainlab Elements, including BOLD MRI Mapping (1.0), is a suite of software applications that process and analyze medical image data to assist clinicians in planning surgeries and radiation treatments. It incorporates AI for tumor segmentation and supports various modalities.
2023-07
FDA
K243633 - 510(k) Premarket Notification - FDA
This is a 510(k) Premarket Notification for Brainlab Elements (7.0), which includes Brainlab Elements BOLD MRI Mapping (1.0), submitted by Brainlab AG. The FDA approval date for this suite of devices is June 13, 2025.
2025-06
RadAI Slice
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) | FDA Radiology AI Device
Brainlab Elements (7.0) is a medical imaging software suite that aids clinicians in planning cranial and extracranial surgical and radiotherapy treatments, offering tools for image fusion, contouring, fibertracking, and BOLD MRI activation analysis.
2025-06
Innolitics
QIH u00b7 Automated Radiological Image Processing Software u2014 FDA Product Code | Innolitics
This page lists Brainlab Elements BOLD MRI Mapping (1.0) as a cleared traditional device under the FDA product code QIH for Automated Radiological Image Processing Software, with a clearance date of June 13, 2025.
2025-06
FDA
June 13, 2025 Brainlab AG Sadwini Suresh QM Consultant Olof-Palme-Str.9 Munich, 81829 Germany Re: K243633 Trade/Device Name - accessdata.fda.gov
This FDA document details the 510(k) premarket notification for Brainlab Elements (7.0), including BOLD MRI Mapping (1.0), which is indicated for planning cranial surgical treatments and provides tools to analyze blood oxygen level dependent data to visualize activation signals.
2025-06
RadAI Slice
Mixed Reality Spine Navigation | FDA Radiology AI Device - X-ray Interpreter
Brainlab Elements BOLD MRI Mapping (1.0) is listed among other Brainlab AG devices with a 510K approval expected in 2025, indicating its role in the broader Brainlab portfolio of medical imaging and navigation solutions.
2025-05
Brainlab
CE marking - Brainlab
Brainlab Elements BOLD MRI Mapping 1.0 has received CE 0123 marking from Tu00dcV Su00dcD Product Service GmbH, signifying its conformity with European health, safety, and environmental protection standards.
unknown
FDA.report
K243633: Brainlab Elements (7.0); Brainlab Elements Image Fusion ...
This entry confirms the FDA decision date of June 13, 2025, for Brainlab Elements (7.0), which includes Brainlab Elements BOLD MRI Mapping (1.0), under product code QIH.
2025-06

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Frequently Asked Questions

Brainlab Elements BOLD MRI Mapping (1.0) provides tools to analyze blood oxygen level dependent (BOLD) data, visualizing activation signals and correlations between brain areas to aid in planning cranial surgical treatments. While it incorporates advanced AI features, its effectiveness relies significantly on the quality of input images and user-defined parameters. The software is specifically indicated for processing medical image data to support image-guided surgery and radiation treatment planning, rather than direct diagnosis.
Brainlab Elements BOLD MRI Mapping (1.0) is part of the Brainlab Elements Suite, which has received 510(k) Premarket Notification from the FDA (e.g., K223106 in 2023 and K243633 in 2025 for updated versions). For data privacy, Brainlab Cloud Services, likely used with the suite, employs SSL encryption, AES 256-bit key encryption, and stores patient data on ISO 27001, SOC 1/SSAE 16/ISAE 3402, and FISMA certified data centers. It also offers pseudonymization options and stores US patient data on US servers and EU data on EU servers.
The primary limitations include its dependency on proper hardware and user expertise, as the AI features are highly sensitive to input image quality and user-set parameters. Furthermore, BOLD fMRI itself has inherent technical challenges such as susceptibility artifacts, which can lead to reduced sensitivity in certain brain regions, and a general need for standardized acquisition and analysis methods. The software is intended for planning, not for diagnostic purposes.
Competitors in the broader medical technology space include ClaroNav, Synaptive, and XION. For functional MRI analysis specifically, alternatives include Olea Medical's fMRI analysis solution, MIStar, and open-source platforms like 3D Slicer, FSL, FreeSurfer, SPM, and OsiriX.
While specific pricing for BOLD MRI Mapping (1.0) is not publicly detailed, Brainlab navigation systems, which often include such modules, can range from $400,000 to $800,000+, with costs varying significantly based on specific needs. The total cost typically includes a one-year licensing support agreement, with subsequent annual payments required for both licensing and service contracts after the initial warranty period.
Effective operation of the Brainlab Elements suite, including BOLD MRI Mapping (1.0), requires a computing environment that meets specific hardware criteria and trained personnel. The system is designed to be compatible with state-of-the-art MRI scanners and operating room tables from various manufacturers, offering flexibility in integration.

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