Elements Segmentation [Cranial

by Brainlab  · Based in Germany → — Automating and standardizing cranial segmentation for precision surgery and radiotherapy.
Neurosurgery Oncology Radiology
Website
Claim this tool
Is this the maker? Claim the company →

Contact for pricing
Regulatory Status Disclosed

Overview

Elements Segmentation [Cranial] is an advanced AI-powered software application developed by Brainlab, designed to provide highly accurate and patient-specific anatomical segmentation of cranial structures. This tool is a key component of Brainlab’s broader Elements suite, which digitizes, automates, and optimizes clinical workflows for various medical specialties, including neurosurgery and radiation oncology.

The application leverages a patented Synthetic Tissue Model and a voxel-based tissue classification feature from the Brainlab Universal Atlas to automatically generate detailed anatomical segmentations. This allows clinicians to account for individual patient variability, asymmetry, and anomalies, and to make fine adjustments using intuitive editing tools like SmartShaper™.

Elements Segmentation [Cranial] streamlines the time-consuming contouring process, enhancing efficiency and consistency in treatment planning. It processes DICOM image sets and outputs 3D DICOM segmentation objects, which are crucial for further processing and the creation of radiation therapy dose plans.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Automated, patient-specific anatomical segmentation
  • Leverages voxel-based tissue classification from Brainlab Universal Atlas
  • Accounts for anatomical variability, asymmetry, and anomalies
  • Fine adjustment tools (e.g., SmartShaperu2122)
  • Thorough and automated anatomical mapping via patented Synthetic Tissue Model
  • Efficient and consistent automation of contouring processes
  • Supports various cranial indications for planning
  • Integration into surgical and radiotherapy workflows
  • DICOM image set processing and 3D DICOM segmentation object output
  • AI Tumor Segmentation (available for some Elements products)

Use Cases

  • Preoperative planning for neurosurgery
  • Radiosurgery treatment planning (e.g., AVMs, pituitary adenomas, vestibular schwannomas, gliomas, meningiomas, brain metastases)
  • Radiotherapy treatment planning
  • Deep Brain Stimulation (DBS) planning
  • Image-guided surgery
  • Research and troubleshooting in neurosurgical applications

What Physicians Need to Know

Brain MRI/CT Analysis
Elements Segmentation [Cranial] provides patient-specific anatomy segmentation, automatically generating accurate anatomical structures by leveraging multiple datasets and voxel-based tissue classification from the Brainlab Universal Atlas. Users can fine-tune segmented anatomy using tools like SmartShaperu2122. The software includes Elements Distortion Correction Cranial for significant reduction of MRI distortions and Elements Image Fusion for fast, automatic, and accurate co-registration between various image modalities. It supports automatic segmentation of skin, bone, cortical vessels, and cerebrum, crucial for detailed pre-operative planning.
AI-Powered Tumor Segmentation
Elements AI Tumor Segmentation integrates artificial intelligence for fast and easy delineation of supported cranial tumors on contrast-enhanced T1-weighted MRI scans, enhancing workflows for multiple brain metastases and retreatment review.
Mobile Access for Planning & Review
Brainlab Elements supports clinicians with multi-platform flexibility, allowing access to full software functionality for planning and review on preferred devices, including iPad and iPhone.
Physician Tip

Leverage the automated, patient-specific anatomical segmentation for highly accurate pre-operative planning and intraoperative guidance. Utilize the MRI distortion correction and multi-modality image fusion capabilities to enhance the precision of surgical targeting and reduce potential inaccuracies. The AI-powered tumor segmentation can significantly streamline the delineation of cranial tumors, improving efficiency in radiosurgery and retreatment planning. For functional neurosurgery, the fibertracking capabilities provide critical insights into white matter pathways, aiding in trajectory planning and avoidance of critical structures. Regularly review and, if necessary, manually adjust automated segmentations to ensure optimal patient-specific outcomes.

Elements Segmentation [Cranial] is part of the broader Brainlab Elements suite, designed for seamless integration within various surgical planning and treatment delivery platforms. It integrates with other Elements modules like Image Fusion, Distortion Correction Cranial, Fibertracking, and Trajectory Planning Cranial. The system supports automatic registration with intraoperative MRI (iMRI), iCT, and other imaging devices, optimizing workflow by incorporating intraoperatively acquired data into the surgical navigation system. It is also compatible with mobile devices for flexible access and review.

Details

Category Neurology AI, Oncology AI, Surgical AI
Pricing Contact for pricing
  • Pricing is not publicly available
  • Brainlab offers flexible business models, from single licenses to multiple offerings across departments
DeploymentOn-premise (workstation-based) with cloud-enabled services for data storage and collaboration.
Compliance
BAA AvailableUnknown AI-estimated
HIPAA Compliant Yes AI-estimated
FDA Status Yes AI-estimated

The device, including "Elements Segmentation [Cranial , Basal Ganglia, Head & Neck, Pelvic, Spine, Thoracic & Spine, Extracranial] RT", received FDA 510(k) clearance (K250440) on June 17, 2025. It is intended for radiation treatment planning in stereotactic, conformal, computer-planned, Linac-based radiation treatments for cranial, head and neck, and extracranial lesions. It is a software-only device.
Integrations
EHR Not specified
Specialties Neurosurgery, Oncology, Radiology

What the Web Says

Brainlab Elements Segmentation [Cranial] is an AI-powered software designed for automated, knowledge-based anatomical segmentation of cranial structures for surgical and radiotherapy planning. It aims to provide efficient and consistent automation of time-consuming contouring processes, adapting to various anatomies and modalities. The software is intended for pre-, intra-, and postoperative image-based planning and review of neurosurgical and neurological procedures, and it is not intended for diagnostic purposes.

Overall: Positive

Strengths

  • Automated and consistent anatomical segmentation.
  • Adapts to various anatomies and imaging modalities.
  • Efficient automation of time-consuming contouring.
  • High precision, recall, and Dice similarity coefficients in performance testing.
  • Intuitive, easy-to-use review and editing tools.
  • Enhances precision of radiotherapy delivery and improves tumor control rates.

Limitations

  • Requires specific hardware requirements to run on Windows platforms.
  • Not intended for diagnostic purposes.
  • Limited information available from independent review platforms like G2, Capterra, or Reddit in the search results.

Based on reviews from: Brainlab, FDA Radiology AI Device, VA.gov, X-ray Interpreter, BEUDAMED, LA Vascular, FDA.report, accessdata.fda.gov

Last updated: 2026-07-17

Ratings & Reviews

No reviews yet. Be the first to review this tool!

Rate Elements Segmentation [Cranial

Clinical Value
Ease of Use
Integration
Support & Docs
Value for Money

Press & Coverage

FDA
510(k) Premarket Notification - Elements Segmentation [Cranial
Brainlab AG received 510(k) premarket notification for Elements Segmentation [Cranial, Basal Ganglia, Head & Neck, Pelvic, Spine, Thoracic & Spine, Extracranial] RT, among other Elements software. This regulatory announcement indicates the device can be marketed for its intended use in radiation treatment planning.
2026-06
Brainlab
Functional Neurosurgery Planning Solutions - Brainlab
Brainlab highlights its Elements Segmentation Cranial as a key component for patient-specific planning in functional neurosurgery, leveraging automated, knowledge-based anatomical segmentation. The article emphasizes its role in generating accurate anatomy by factoring in multiple datasets and utilizing the voxel-based tissue classification feature from the Brainlab Universal Atlas.
2026-05
SAM.gov
6525--Combined Synopsis: Intent to Compete - BrainLab NODE
A government announcement indicates an intent to compete for BrainLab Elements Segmentation Cranial, highlighting its role in automatic segmentation of anatomical brain structures on MR and CT data sets. This suggests ongoing procurement and utilization of the technology within government healthcare systems.
2026-07
PubMed Central (PMC)
Connectivity-based segmentation of the thalamic motor region for deep brain stimulation in essential tremor: A comparison of deterministic and probabilistic tractography - PMC
This peer-reviewed article details a study where Brainlab Elements Segmentation Cranial (version 5.0.0.72) was used for automatic segmentation of thalamus and precentral gyrus ROIs for deep brain stimulation planning in essential tremor patients. The research compares deterministic and probabilistic tractography methods.
2024-02
X-ray Interpreter
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
This article from a healthcare IT publication mentions Brainlab Elements Segmentation [Cranial, Basal Ganglia, Head & Neck, Pelvic, Spine, Thoracic & Spine, Extracranial] RT as part of the Brainlab Elements suite, which processes and analyzes medical image data for surgical and radiation treatment planning. It highlights the incorporation of AI via a convolutional neural network for tumor segmentation.
2023-07
EBRAINS
EBRAINS Multilevel Human Brain Atlas A Market Analysis of the Technology
A market analysis report from EBRAINS in 2020 references Brainlab Elements Segmentation Cranial as a software for fully automated, knowledge-based anatomical segmentation based on a patented Synthetic Tissue Model. It notes its relevance to neuronavigation and neurosurgical planning.
2020-01
VA.gov
Brainlab Elements - VA.gov
The VA.gov website describes Brainlab Elements Segmentation Cranial as fundamental to treatment planning, offering automated, knowledge-based anatomical segmentation that adapts to various anatomies and modalities. It emphasizes its unique technology based on a patented Synthetic Tissue Model for consistent and efficient contouring.
unknown
Therapeutic Goods Administration (TGA) Australia
DEVICE DETAILS
This regulatory document from the TGA lists 'Elements Segmentation Cranial' as a Brainlab device for image processing of medical images, specifically for automatic, atlas-based segmentation of anatomical structures based on CT and MR imaging modalities. It highlights its role in providing segmentation, contouring, fusion, and data transfer functionalities.
2018-09

Videos

Product demos, reviews, and walkthroughs for Elements Segmentation [Cranial.

View all on YouTube

Frequently Asked Questions

Elements Segmentation [Cranial] integrates by automating critical steps in the planning workflow, including image fusion, distortion correction, object outlining, and segmentation. This streamlines the pre-planning process for cranial surgeries and radiation therapy, providing efficient data preprocessing and 3D visualizations for clinicians.
Brainlab's RT Elements, which includes Elements Segmentation [Cranial], has received FDA clearance (e.g., K250440, K243633) for radiation treatment planning. While specific HIPAA details are not publicly detailed for this product, as a medical device software, it is expected to adhere to stringent data privacy and security regulations for patient information.
Elements Segmentation [Cranial] offers automated, AI-driven segmentation, significantly reducing the time and inter-operator variability associated with traditional manual methods. Compared to other AI solutions, it is specifically designed for cranial stereotactic radiosurgery and treatment planning, incorporating features like 4Pi arc setup optimization and protocol-driven treatment plans.
Publicly available information indicates 'No price information available' or mentions 'Free Trial' and 'Free Version' for Elements Cranial SRS. Pricing for professional medical software like this is typically enterprise-based and negotiated directly with Brainlab sales representatives, with options likely tailored to the specific needs and scale of a healthcare institution.
Potential limitations of AI segmentation can include sensitivity to image quality issues like noise or artifacts, and challenges with anatomical deviations or complex pathologies not well-represented in training data. While the software aims for high accuracy, users should be aware that segmentation results can be influenced by contrast and spatial resolution, and manual review is often part of the clinical workflow.
Elements Cranial SRS aims for submillimeter accuracy and reliability through its automated workflow. The AI tumor segmentation feature has undergone quantitative validation against ground-truth annotations and was trained on MRI image data with contrast-enhancing tumors from multiple clinical sites, encompassing a wide variety of scanner models and patient characteristics.
Brainlab provides training documentation for its Elements software. While specific details on comprehensive training programs are not extensively detailed in public search results, as a sophisticated medical device, ongoing support and training are typically part of the vendor agreement to ensure proper and effective utilization by clinical staff.

Related Tools

Cercare Medical Oncology Virtual Expert
Cercare Medical
Neurology AI
Cercare Medical's Oncology Virtual Expert is an AI-powered brain tumor segmentation module that provides fast, consistent, and semi-automated tumor analysis from standard MRI data, designed for on-premise deployment within existing clinical radiology workflows.
CoLumbo C-Spine
Smart Soft Healthcare AD
Clinical Decision Support & Reference
CoLumbo C-Spine is an AI-powered software that processes and analyzes cervical spine MRI exams, assisting clinicians in diagnosis and assessment.
MeRT System
Wave Neuroscience
Mental & Behavioral Health AI
MeRT (Magnetic e-Resonance Therapy) is an advanced, personalized form of TMS that uses your own brainwave data to guide treatment. It's a non-invasive, drug-free option designed to help the brain communicate more efficiently so symptoms of conditions like depression, anxiety, PTSD, TBI, autism, and more can improve.
Paid
Brainomix 360 Hyperdensity
Brainomix Limited
Neurology AI
Brainomix 360 Hyperdensity is an AI-powered neuroimaging software tool that detects and quantifies brain hyperdensities on CT scans, forming a crucial part of the Brainomix 360 Stroke platform for rapid and accurate stroke assessment.
SOMNUM
HoneyNaps
Clinical Decision Support & Reference
SOMNUM is an AI-enabled medical software tool by Honeynaps Co., Ltd. that provides comprehensive sleep analysis to aid in the diagnosis and management of sleep disorders.
DETECT-ME/CFS project
DETECT-ME/CFS project (ME/CFS Research Foundation)
Clinical Decision Support & Reference
The DETECT-ME/CFS project is developing an AI-supported clinical decision support system to improve the rapid and reliable diagnosis of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome.

See all Neurology AI tools →

More from Brainlab

(Elements) Cranial SRS w/ Cones
Brainlab
Neurology AI
Brainlab Elements Cranial SRS w/ Cones is an AI-powered software for precise stereotactic radiosurgery planning, offering automated workflows for cranial lesions and functional diseases.
Contact for pricing
(Elements) RT Planning Platform
Brainlab
Oncology AI
The Brainlab Elements RT Planning Platform is a comprehensive suite of software applications for streamlined and enhanced radiation therapy and radiosurgery treatment planning, offering advanced capabilities and automated workflows for various clinical indications. [9, 11, 12, 27]
Contact sales
TraumaCad Neo (1.1)
Brainlab
Radiology & Imaging AI
TraumaCad Neo (1.1) is an FDA-cleared, cloud-based orthopedic templating software by Brainlab, offering comprehensive tools for preoperative planning, including digital template libraries, automated measurements, and post-operative review for various orthopedic procedures.
Contact vendor

View company profile →

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

Investors who backed Elements Segmentation [Cranial

Funded through the company that built this tool.

Prosus Ventures
VC AI T1
Amsterdam, Netherlands
$25M+
Prosus Ventures is the venture arm of one of the largest global technology investment groups, with deep roots in consumer internet, marketplaces,…
Care Delivery / Tech-Enabled Services Digital Health
AI Tool Finder
AI-powered search. Results may not be comprehensive.