Brainlab Elements (7.0)

by Brainlab  · Based in Germany → — Innovating Medtech for Better Patient Outcomes
Neurosurgery Oncology Radiology
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Regulatory Status Disclosed

Overview

Brainlab Elements is a comprehensive suite of advanced software applications designed for medical image processing, surgical planning, and radiation treatment planning. It transforms traditional 2D medical scans, such as MRIs and CTs, into interactive 3D anatomical maps, providing surgeons with high-precision navigation capabilities. The platform supports a wide array of clinical subspecialties, including neurosurgery, spine surgery, orthopedics, and radiation oncology. By offering tools for accurate image fusion, patient-specific planning, and automated workflows, Brainlab Elements aims to enhance documentation, communication, and integration within the operating room and treatment planning processes, ultimately improving patient outcomes. The software integrates artificial intelligence features, such as AI Tumor Segmentation, to streamline complex tasks and further improve planning accuracy and efficiency.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • 3D Visualization and Interactive Anatomical Maps
  • Image Fusion (CT/MR, DWI, BOLD MRI)
  • Patient-Specific Planning
  • Advanced Segmentation Tools (e.g., Basal Ganglia, Cranial, AI Tumor Segmentation)
  • Trajectory Planning (Cranial, Stereotaxy)
  • Fibertracking for Neural Pathways Visualization
  • Automated Radiosurgery Planning (e.g., Multiple Brain Metastases SRS, Cranial SRS, Spine SRS)
  • Intraoperative Structure Update
  • Retreatment Review and Planning
  • DICOM Data Transfer and Processing

Use Cases

  • Preoperative planning for neurosurgery (e.g., tumor removal, DBS, sEEG, biopsies)
  • Radiation treatment planning (radiosurgery, radiotherapy)
  • Spine surgery planning and navigation
  • Orthopedic surgery planning
  • Craniomaxillofacial and ENT surgery planning
  • Postoperative verification and assessment

What Physicians Need to Know

Brain MRI/CT Analysis
Brainlab Elements converts traditional 2D medical scans, such as MRIs and CTs, into interactive 3D anatomical maps for surgical planning. It offers advanced 3D visualization for enhanced spatial anatomical orientation and supports the processing of medical image data for image-guided surgery and radiation treatment planning. The software includes modules for 2D & 3D image viewing, image processing, image co-registration, image segmentation, and 3D visualization. It also features automated rigid fusion between preoperative MRI images and intraoperative ultrasound images, allowing surgeons to update registration and navigate on updated patient anatomy. Brainlab Elements can also visualize and analyze brain white matter pathways using Diffusion Tensor Imaging (DTI) and constrained spherical deconvolution (CSD) analysis, which can identify multiple fiber directions, including crossing and fanning fibers, and fibers in edema. It also provides tools to analyze task-based blood oxygen level dependent data (BOLD MRI Data) to visualize activation signals. The software also includes AI features for identifying previously diagnosed lesions or tumors in T1-Weighted Contrast-Enhanced Magnetic Resonance (T1+C MR) volumetric images, utilizing a Convolutional Neural Network (CNN) developed with a supervised learning approach. Additionally, Brainlab Elements offers automated knowledge-based anatomical segmentation for accurate structure labeling and editing.
Neurodegenerative Disease Screening
While the provided information does not explicitly state direct neurodegenerative disease screening capabilities, Brainlab Elements' advanced MRI/CT analysis, including BOLD MRI Mapping and Fibertracking, can provide detailed insights into brain function and white matter integrity, which are relevant for understanding and potentially identifying aspects related to neurodegenerative conditions. The software's ability to visualize neural pathways and analyze brain activity could indirectly support the assessment of neurodegenerative diseases.
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. AI-based capabilities within the integrated operating room environment can help surface relevant information and support workflow coordination through automated coordination, notifications, and next-step support.
Physician Tip

Brainlab Elements provides a comprehensive suite of tools for neurosurgeons and radiation oncologists, enabling highly precise planning and execution of treatments. The advanced 3D visualization and image fusion capabilities are crucial for understanding complex anatomies and planning optimal surgical approaches or radiation delivery. Utilizing the Fibertracking module can significantly enhance surgical safety by visualizing critical neural pathways and aiding in their preservation during tumor removal or other interventions. The automated segmentation and planning features can drastically reduce planning time, allowing for more efficient workflows and potentially increasing patient access to advanced treatments. Leveraging the mobile compatibility allows for flexible review and collaboration, even outside the operating room. For radiosurgery, the ability to generate complex radiation plans for multiple brain metastases in minutes, rather than hours, is a significant advantage. The AI-powered tumor segmentation can further streamline contouring processes. The integration with intraoperative imaging and robotics can provide real-time updates and enhance accuracy during procedures.

Brainlab Elements is designed for seamless integration within various clinical subspecialties, including neurosurgery, spine surgery, orthopedics, and radiation oncology. It integrates with other Brainlab platforms like Curve™ Image Guided Surgery and Buzz® Digital O.R. for optimized utilization. The software is compatible with PACS for accessing patient data and can transfer DICOM data. It also supports integration with robotic systems like Cirq® for precise sEEG electrode placement and Loop-X® for intraoperative imaging. The system is built on an open, scalable, and modular foundation, allowing for vendor-agnostic integration and connection to third-party technologies.

Details

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

Support & Reliability

Training Provided Yes

What the Web Says

Brainlab Elements (7.0) is a suite of software applications designed to enhance surgical planning and radiation treatment, particularly in neurosurgery, spine surgery, and radiation oncology. It transforms traditional 2D medical scans into interactive 3D anatomical maps, offering "GPS-level precision" for surgeons. The software aims to streamline workflows, improve accuracy, and facilitate patient-tailored planning through various modules like Fibertracking, Cranial Planning, and Multiple Brain Metastases SRS.

Overall: Positive

Strengths

  • Revolutionizes neurosurgery with advanced visualization and analysis of brain white matter pathways, enhancing neurological understanding and patient care.
  • Streamlines patient-specific planning by integrating combined MRI and DWI data with an intuitive user interface and instant updates.
  • Offers advanced tracking capabilities, including research-grade probabilistic tractography, to identify multiple fiber directions and fibers in edema.
  • Automates various pre-planning steps like image fusion, distortion correction, object outlining, and segmentation, leading to increased accuracy and efficiency.
  • Provides multi-platform flexibility, allowing clinicians to work online or offline on preferred devices, including iPads and iPhones.
  • Reduces planning time significantly, potentially by up to 80%, making advanced treatments more accessible to smaller clinics.

Limitations

  • Requires proper hardware and user expertise for effective operation.
  • AI features are highly dependent on the quality of input images and user-defined parameters.
  • Not intended for direct diagnosis or creating physical replicas for diagnostic purposes.

Based on reviews from: medicalexpo.com, brainlab.com, fda.gov, medicalnewsobserver.com, slashdot.org, innolitics.com, healthcareaiops.com, youtube.com, sourceforge.net, reddit.com, expertini.com

Last updated: 2026-10-29

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Press & Coverage

FDA
Brainlab Elements (7.0) 510(k) Premarket Notification
Brainlab Elements (7.0) received 510(k) premarket notification clearance from the FDA on June 13, 2025, indicating it is substantially equivalent to a predicate device. The submission includes various components like Image Fusion, Contouring, Fibertracking, and BOLD MRI Mapping.
2025-06
The Healthcare AI Institute
Brainlab Elements (7.0) on Healthcare AI Institute Transparency Registry
Brainlab Elements (7.0) is listed on The Healthcare AI Institute's Transparency Registry under K243633, noting that a peer-reviewed validation publication is not yet available.
unknown
Brainlab
Brainlab Receives CE Mark for Elements Spine Planning
Brainlab announced the CE marking and market launch of its Elements Spine Planning solution in the EU on May 21, 2026. This AI-based software is designed to standardize and enhance preoperative planning for spine surgery, particularly for sagittal spinal alignment.
2026-05
Brainlab
Elements Spine Planning now FDA 510(k) cleared
Brainlab's Elements Spine Planning has received FDA 510(k) clearance, enabling clinicians to analyze patient-specific spinopelvic parameters and plan sagittal alignment for spine conditions. The software utilizes AI algorithms to assist with planning steps and provides real-time measurement updates with a patient-specific spine avatar.
2026-10
Innolitics
Brainlab Elements (7.0) on Innolitics FDA Device List
Innolitics lists Brainlab Elements (7.0) as a cleared traditional device with a clearance date of June 13, 2025, alongside other Brainlab Elements components. The entry specifies that the software provides automated radiological image processing and analysis tools, including nonadaptive machine learning algorithms.
2025-06
medecine.ai
Brainlab Elements (7.0) on medecine.ai
Brainlab Elements (7.0) is listed as a radiology device cleared in 2025, according to the official FDA list of AI-based medical devices. It is part of a suite of Brainlab Elements products for image fusion, contouring, fibertracking, and BOLD MRI mapping.
2025
medtekki.no
Brainlab Elements (7.0) on medtekki.no
Brainlab Elements (7.0) is sourced from the FDA AI list for radiology, indicating its regulatory clearance. It is mentioned alongside other Brainlab Elements for image fusion.
unknown
mordorintelligence.com
Brainlab's Elements 7.0 suite received FDA clearance
Brainlab's Elements 7.0 suite received FDA clearance, as noted in a market analysis report. This clearance is a significant step for the product in the medical imaging and AI market.
2026-09

Videos

Product demos, reviews, and walkthroughs for Brainlab Elements (7.0).

View all on YouTube

Frequently Asked Questions

Brainlab Elements (7.0) incorporates AI for tasks such as tumor segmentation, assisting in cranial planning and visualization tools for neurosurgery. It also uses AI algorithms to help with time-consuming planning steps in spine surgery, such as analyzing patient-specific spinopelvic parameters and planning sagittal alignment.
Brainlab Elements (7.0) and its modules, such as Image Fusion, Contouring, Fibertracking, and BOLD MRI Mapping, are FDA 510(k) cleared as software applications for processing medical image data to support image-guided surgery and radiation treatment planning. These tools are intended to assist the user group in performing these procedures and are not for direct diagnosis or creating physical replicas for diagnostic purposes.
While Brainlab Elements offers specific AI-powered tools for neurosurgical planning and radiotherapy, other AI tools in neurology focus on different aspects. Alternatives include AI for acute stroke imaging and communication workflows (e.g., Viz.ai, RapidAI), AI scribes for clinical documentation (e.g., DeepCura AI, Freed AI), and clinical decision support systems (e.g., EvidenceMD, MedLink AI).
The primary limitations of the Brainlab Elements suite include its dependence on appropriate 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, the software's AI features, while advanced, are heavily reliant on the quality of the input images and the parameters set by the user.
Brainlab Elements (7.0) enhances neurosurgical planning by converting 2D medical scans into interactive 3D anatomical maps, providing GPS-like precision for brain and spinal surgeries. It visualizes neural pathways for safer operations, improves radiation targeting, and streamlines pre-planning workflows, ultimately aiming to amplify surgeons' skills and improve patient outcomes.

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