(Elements) Cranial SRS w/ Cones

by Brainlab  · Based in Germany → — Pioneering digital medical technology for enhanced patient outcomes.
Neurosurgery Oncology
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Regulatory Status Disclosed

Overview

Brainlab Elements Cranial SRS w/ Cones is a sophisticated software application designed for stereotactic radiosurgery (SRS) planning for cranial indications. It streamlines workflows for complex procedures by integrating automation at every step, including image fusion, distortion correction, object outlining, and segmentation, ensuring submillimetric accuracy and consistency. The tool provides planning and display capabilities for functional diseases, such as trigeminal neuralgia, and various cranial lesions. It leverages a patented 4Pi arc setup optimization and a volumetric modulated arc therapy (VMAT) algorithm to achieve high plan quality, delivering highly conformal doses while minimizing radiation to critical structures. The software supports comprehensive plan calculation and review, including isodose lines, conformity index, and dose-volume histograms, and facilitates the saving and exporting of DICOM RT dose plans. It is utilized by radiation oncology and radiology teams for 3D visualization, case preparation, and decision support around brain SRS cases.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Automated radiation treatment planning for cranial lesions and functional diseases
  • Image fusion and distortion correction
  • Automatic organ at risk (OAR) detection
  • Intuitive and automatic treatment plan creation
  • Patented 4Pi arc setup optimization algorithm
  • Volumetric Modulated Arc Therapy (VMAT) algorithm
  • Comprehensive plan calculation and review (isodose lines, conformity index, min/max doses)
  • Saving and exporting DICOM RT dose plans
  • 3D visualization of cranial anatomy and structures
  • Supports retreatment planning by integrating prior PTV information
  • AI-powered tumor segmentation (part of the broader RT Elements suite)

Use Cases

  • Stereotactic radiosurgery (SRS) planning for cranial indications
  • Treatment planning for functional diseases (e.g., trigeminal neuralgia)
  • Treatment planning for cranial lesions (e.g., AVMs, pituitary adenomas, vestibular schwannomas, brain metastases)
  • Image review, target/structure visualization, and plan-related evaluation
  • Retreatment planning for recurrent multiple brain metastases
  • Quality assurance for radiation treatment plans

What Physicians Need to Know

Brain MRI/CT Analysis
Elements Cranial SRS w/ Cones utilizes CT, MRI, and PET image data for comprehensive treatment planning. It supports advanced image fusion, including data from Contrast Clearance Element analysis for dynamic contrast-enhanced MRI. The system features RT Contouring for precise outlining and manipulation of structures, along with AI-driven tools like Elements AI Tumor Segmentation RT and Elements SmartBrush for automated segmentation. It provides robust 3D visualization of cranial anatomy and structures, essential for reviewing spatial relationships and assessing contours and targets. Furthermore, the Elements Cranial Distortion Correction algorithm significantly ameliorates MRI distortions, enhancing the accuracy of lesion delineation for cranial stereotactic radiotherapy (SRT).
Triage Prioritization Speed
While not a diagnostic triage tool, Elements Cranial SRS w/ Cones significantly enhances workflow efficiency in stereotactic radiosurgery (SRS) planning. It can rapidly and automatically generate SRS plans for complex indications, facilitating faster planning and treatment delivery. The software incorporates indication-specific, intelligent workflows that automate various procedures, allowing clinical staff to dedicate more time to patient care. Preplanning solutions, when integrated, can substantially reduce the time required for treatment planning on the day of treatment. The automatic 4Pi trajectory optimization algorithm contributes to streamlining the planning process by producing collision-free, clinically deliverable plans with improved dose conformality and reduced monitor units (MUs).
Mobile Notification System
As part of the Brainlab Elements suite, Cranial SRS w/ Cones supports flexible access for clinicians, enabling planning and review on various devices, including iPads and iPhones. The platform, through tools like Quentryu00ae, facilitates efficient departmental, cross-functional, and external expert collaboration, suggesting capabilities for information sharing and potentially notifications across the care team.
Physician Tip

Leverage the automated planning and optimization algorithms within Elements Cranial SRS w/ Cones to streamline your SRS workflow, ensuring high-quality, patient-tailored treatment plans with efficient dose delivery. Utilize the advanced MRI distortion correction and 3D visualization capabilities for precise target and organ-at-risk delineation. Consider integrating preplanning strategies to further reduce on-treatment-day planning time and enhance overall patient comfort and throughput. The mobile access features allow for flexible review and collaboration, supporting multidisciplinary team discussions.

Brainlab Elements Cranial SRS w/ Cones is designed to integrate seamlessly within existing radiation oncology ecosystems. It processes DICOM image sets from various modalities (CT, MRI, PET) and generates DICOM RT dose plans for further processing and control of linear accelerators. It complements Picture Archiving and Communication Systems (PACS) and Oncology Information Systems (OIS) by providing specialized SRS planning capabilities while allowing these core departmental systems to maintain records and manage patient administration.

Details

Category Neurology AI, Oncology AI, Surgical AI
Pricing Contact for pricing — No public pricing information available; contact Brainlab for details.
DeploymentWorkstation-based software with cloud-connected features and mobile access.
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

Cleared under 510(k) Premarket Notification K250440 on June 17, 2025. It is a Class II medical device (Regulation Number: 21 CFR 892.5050, Product Code: MUJ, QIH) intended for radiation treatment planning for stereotactic, conformal, computer-planned, Linac-based radiation treatment of cranial, head and neck, and extracranial lesions.
Integrations
EHR Not specified
Specialties Neurosurgery, Oncology

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Press & Coverage

FDA
510(k) Premarket Notification - K250440
Brainlab AG received 510(k) premarket notification for its RT Elements (4.5) system, which includes (Elements) Cranial SRS w/ Cones, on June 17, 2025. This regulatory clearance allows Brainlab to market the device for radiation treatment planning.
2025-06
FDA Radiology AI Device
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 FDA listing from July 14, 2023, details Brainlab Elements software, including (Elements) Cranial SRS w/ Cones, highlighting its AI integration for tumor segmentation and support for various imaging modalities. The software is intended for treatment planning in cranial and ENT surgeries and radiotherapy.
2023-07
Brainlab
Functional Radiosurgery Masterclass 2026 - Brainlab
Brainlab is hosting a Functional Radiosurgery Masterclass in 2026, which will feature Elements Cranial SRS w/ Cones for functional treatment planning using conical collimators to generate steep dose gradients. The masterclass will provide expert insights into managing clinical and technical complexities of functional treatments.
2026-XX
FDA.report
System, Planning, Radiation Therapy Treatment MUJ - FDA.report
This report lists Brainlab AG's RT Elements (4.5) system, including (Elements) Cranial SRS w/ Cones, as a Class II medical device with product code MUJ, cleared by the FDA on June 17, 2025. It is categorized under 'System, Planning, Radiation Therapy Treatment'.
2025-06
Brainlab
Cranial 4Pi Immobilization - Brainlab
Brainlab's Cranial 4Pi Immobilization system is designed to optimize radiosurgery immobilization for cranial SRS treatments, ensuring precise treatment delivery. It is related to Elements Solutions for Cranial Functional SRS and uses conical collimators to generate plans with steep dose gradients.
unknown
Brainlab
CE marking - Brainlab
Brainlab's RT Elements u2013 Cranial SRS w/ Cones 3.0 has received CE 0123 marking from Tu00dcV Su00dcD Product Service GmbH, indicating its conformity with European health, safety, and environmental protection standards.
unknown
LA Vascular
rt elements 4 5 elements multiple brain mets srs elements cranial srs elements spine srs elements cranial srs w cones elements rt planning platform elements dose review elements retreatment review elements segmentation cranial basal ganglia head neck pelvic spine thoracic spine extracranial rt elements ai tumor segmentation rt elements smartbrush angio spine rt elements object management rt - LA Vascular
This article highlights the FDA clearance of Brainlab AG's RT Elements platform, including (Elements) Cranial SRS w/ Cones, on June 17, 2025, as a Class 2 medical device. It emphasizes the platform's efficacy in precise tumor targeting for multiple brain and spine SRS applications, utilizing advanced AI for segmentation and dose planning.
2025-06

Videos

Product demos, reviews, and walkthroughs for (Elements) Cranial SRS w/ Cones.

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Frequently Asked Questions

AI can significantly enhance Cranial SRS by automating and improving the precision of tasks like tumor segmentation and contouring of organs at risk, which are traditionally time-consuming and prone to variability. It can also optimize cone selection and placement, refine dose distribution, and assist in quality assurance checks, potentially leading to more efficient and accurate treatment plans.
Integrating AI tools requires rigorous validation and often necessitates FDA clearance as medical devices to ensure safety and efficacy. Compliance also involves adhering to data privacy regulations like HIPAA and GDPR, ensuring secure handling and anonymization of sensitive patient information used by AI algorithms. Furthermore, providers must evaluate AI systems for bias and document mitigation efforts to comply with regulations like ACA Section 1557.
Traditional manual planning by experienced medical physicists and radiation oncologists remains a robust alternative, relying on their expertise and established protocols. These methods might be preferred for highly unusual or complex cases not adequately represented in AI training data, or when AI system validation is still nascent. Additionally, resource-limited settings might opt for traditional methods if AI infrastructure is not readily available or cost-prohibitive.
The cost structure for AI solutions in Cranial SRS can include initial software licensing, hardware upgrades, integration services, and ongoing maintenance and support fees. While AI can offer cost savings through increased efficiency and reduced planning time, these upfront and recurring expenses need to be carefully weighed against potential gains in efficiency and improved patient outcomes, which may influence departmental budgets and patient billing models.
AI models are limited by the diversity and quality of the data they are trained on, potentially struggling with highly atypical cases, rare pathologies, or patient populations not well-represented in their datasets. They may also lack the nuanced clinical judgment required for complex decision-making, interpreting unforeseen patient responses, or adapting to anatomical variations that deviate significantly from learned patterns.
Ensuring patient data privacy and security involves robust data encryption, anonymization techniques, and secure access protocols, especially for sensitive medical information. Compliance with regulations like HIPAA and GDPR, along with strict vendor agreements and continuous monitoring, are essential to protect patient data from unauthorized access or breaches.
Validation of AI algorithms typically involves extensive testing against ground truth data, clinical trials, and comparison with expert human performance. Ongoing monitoring includes regular performance audits, recalibration, and human oversight to detect any drift or errors in the AI's recommendations over time, ensuring continued accuracy and reliability in diverse clinical settings.

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

Investors who backed (Elements) Cranial SRS w/ Cones

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
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