RT Elements (4.5)

by Basal Ganglia — Precision Radiation Therapy Planning Powered by AI (Note: This tool, RT Elements (4.5), is developed by Brainlab AG, not a company named Basal Ganglia. 'Basal Ganglia' in the FDA clearance refers to an anatomical region for segmentation within the software's capabilities.)
Neurosurgery Oncology Radiology
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Regulatory Status Disclosed

Overview

RT Elements (4.5) is an advanced software platform for radiation therapy treatment planning, developed by Brainlab AG. It is designed to assist medical professionals, including radiation oncologists, medical physicists, and neurosurgeons, in creating precise and efficient treatment plans for various lesions. The system leverages AI and machine learning for tasks such as tumor segmentation, enhancing the accuracy and speed of contouring and dose optimization.

The software provides a comprehensive suite of applications, including tools for multiple brain metastases radiosurgery (SRS), cranial SRS, spine SRS, and a general RT Planning Platform. Key functionalities encompass dose review, retreatment review, and advanced segmentation capabilities for anatomical regions like cranial, basal ganglia, head & neck, pelvic, spine, and extracranial areas.

RT Elements (4.5) aims to streamline workflows, spare organs at risk, and deliver highly conformal radiation doses, ultimately improving patient outcomes in stereotactic, conformal, and Linac-based radiation treatments.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • AI Tumor Segmentation RT (Cranial tumors on contrast-enhanced T1-weighted MRI)
  • Multiple Brain Mets SRS planning
  • Cranial SRS planning
  • Spine SRS planning
  • RT Planning Platform
  • Dose Review (isodose lines, DVHs, dose comparison/summation)
  • Retreatment Review (overview of previous and new targets, dose overlays)
  • Elements Segmentation (Cranial, Basal Ganglia, Head & Neck, Pelvic, Spine, Thoracic & Spine, Extracranial)
  • SmartBrush (Angio, Spine) RT
  • Object Management RT

Use Cases

  • Stereotactic Radiosurgery (SRS) for brain and spine lesions
  • Fractionated Stereotactic Radiotherapy (SRT)
  • Stereotactic Ablative Radiotherapy (SABR) / Stereotactic Body Radiation Therapy (SBRT)
  • Automated template-based radiation treatment plan simulation for tumor boards
  • Patient-specific quality assurance (RT QA)
  • Retreatment planning for recurrent multiple metastases

What Physicians Need to Know

Key Capabilities
RT Elements (4.5) offers comprehensive radiation therapy treatment planning and dose optimization for linac-based conformal radiation treatments, including Stereotactic Radiosurgery (SRS), Fractionated Stereotactic Radiotherapy (SRT), and Stereotactic Ablative Radiotherapy (SABR/SBRT) for cranial, head and neck, and extracranial lesions. It features Elements Retreatment Review for a detailed overview of previous treatments and new lesions, aiding in the management of recurrent multiple metastases. The software incorporates AI-powered tumor segmentation for cranial tumors on contrast-enhanced T1-weighted MRI scans. It provides automated processes and standardized workflows for efficient radiosurgery treatment planning, supporting dynamic conformal arc (DCA) and VMAT with 4Pi trajectory optimization. Dose calculation is performed using Pencil Beam (PB) and Monte Carlo (MC) algorithms. Advanced optimization tools include jaw tracking, adaptive margin generation, and an improved packing algorithm.
Clinical Utility
This tool significantly aids clinicians in managing recurrent multiple metastases by providing a comprehensive, color-coded overview of prior treatments and current patient status, facilitating optimal retreatment strategies. It enhances treatment accuracy and can improve patient experience by potentially reducing treatment times and minimizing side effects. RT Elements (4.5) enables personalized decision-making and dose planning through indication-specific tools and streamlines the pre-planning workflow. Studies indicate that it can achieve clinically acceptable SRS plans in less time and with reduced planner involvement compared to previous versions. The system is capable of producing high-quality cranial SRS plans with superior dose conformality, dose gradient, and lower dose to normal organs while using fewer Monitor Units (MUs).
Integration Options
RT Elements (4.5) integrates seamlessly with Brainlab's ExacTrac System for image-guided radiotherapy, ensuring accurate patient positioning and a smooth end-to-end workflow. It offers an interface to the cloud-based 3rd party contouring system 'Art-Plan' by TheraPanacea for auto-segmentation of extracranial structures. The software is designed to work with other Brainlab platforms, such as Curveu2122 Image Guided Surgery and Buzzu00ae Digital O.R. It supports the DICOM standard for exchanging medical images and related information, accepting co-registered DICOM image sets as input and generating DICOM RT dose plans as output. An Anatomical Patient Model (APM) component provides a gRPC API for medical image data processing, allowing access by client applications.
Compliance Status
RT Elements (4.5) received CE approval in May 2023 and is FDA cleared for roll-out in the US as of July 2023. It is classified as a Class II medical device. The device complies with general control provisions of the Act, including requirements for annual registration, device listing, good manufacturing practice, labeling, medical device reporting, and the Unique Device Identification (UDI) Rule.
Pricing Model
Brainlab offers flexible and scalable business models for RT Elements, allowing facilities to access the software based on their evolving needs. Specific pricing details are not publicly disclosed; interested parties are advised to contact a sales representative.
User Experience
The software aims for a positive customer experience, streamlining the pre-planning workflow with intuitive 'Automate, Merge, Contour, View' capabilities accessible via mouse or keyboard. It offers multi-platform flexibility, enabling clinicians to work online or offline on various devices, including workstations, iPads, and iPhones. The latest versions are noted for reducing planner involvement and the time required to achieve clinically acceptable plans.
Support Quality
Brainlab emphasizes providing timely access to Elements and corresponding technical support.
Implementation Complexity
While Brainlab suggests 'easy setup and usage on any device', professional implementation is expected given its integration with existing hospital IT infrastructure and linear accelerators. Hardware requirements for an RT Workstation include Windows 10, a minimum of 6 physical cores, 48GB RAM, and a DirectX 12 compatible graphics card. An RT Server/Virtual Machine requires Windows Server 2016, a minimum of 12 physical cores, and 64GB RAM (plus 16GB per additional user).
Evidence Base
RT Elements (4.5) has undergone verification and validation according to Brainlab's product design and development processes, including performance data verifying accurate dose computation for various linear accelerators. Formative usability evaluations have been conducted. The AI/ML-based Cranial Tumor Segmentation algorithm was trained on MRI data from multiple clinical sites. Clinical studies and presentations at conferences, such as the International Stereotactic Radiosurgery Society Congress (ISRS), support its efficacy. Comparative studies have shown that Elements can offer comparable or superior plan quality, reduced planning/treatment time, and improved dose conformality compared to other planning systems.
Physician Tip

Leverage the AI-powered tumor segmentation for rapid and consistent contouring, especially in complex cases like multiple brain metastases, to save significant planning time. Utilize the Retreatment Review feature to thoroughly assess prior treatment doses and new lesions, enabling informed decision-making for optimal adaptive treatment strategies. Explore the 4Pi trajectory optimization for cranial SRS to achieve highly conformal plans with reduced dose to organs at risk and potentially lower treatment times. Integrate with ExacTrac for enhanced patient positioning and monitoring accuracy during treatment delivery.

RT Elements (4.5) is designed for a highly integrated radiotherapy ecosystem. Its seamless connection with Brainlab's ExacTrac system is crucial for precise image-guided radiation therapy. The DICOM standard support ensures broad compatibility with imaging modalities and other radiotherapy systems. Furthermore, the ability to interface with third-party contouring solutions like Art-Plan and its API for medical image processing highlight its open architecture for expanded workflow integration within a clinical environment.

Details

Category Oncology AI, Surgical AI
Pricing Contact for pricing
  • Pricing is highly variable and depends on specific needs and configurations; contact Brainlab sales representative for a quote
DeploymentSoftware-only, computer-based system, can be integrated with existing Brainlab IGS platforms and PACS systems.
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

RT Elements (4.5) received FDA 510(k) clearance (K250440) on June 17, 2025, for radiation therapy treatment planning, including stereotactic radiosurgery (SRS), fractionated stereotactic radiotherapy (SRT), or stereotactic ablative radiotherapy (SABR) for cranial, head and neck, and extracranial lesions.
Integrations
EHR Not specified
Specialties Neurosurgery, Oncology, Radiology

What the Web Says

Brainlab RT Elements (4.5) is a radiotherapy planning platform designed for stereotactic radiosurgery (SRS) applications, particularly for multiple brain metastases, cranial, and spine treatments. It utilizes advanced AI for tumor segmentation and precise dose planning, aiming to enhance the precision of radiotherapy delivery and improve tumor control rates. The software is noted for its automated processes and standardized workflows, which allow for swift and effective generation and adaptation of treatment plans. It received FDA clearance on June 17, 2025, as a Class 2 medical device.

Overall: Positive

Strengths

  • Enhances precision of radiotherapy delivery and improves tumor control rates.
  • Utilizes advanced AI for tumor segmentation and precise dose planning.
  • Automated processes and standardized workflows for efficient treatment planning.
  • Offers consistency during the treatment planning phase with indication-specific tools.
  • Seamless integration with other Brainlab platforms like Curveu2122 Image Guided Surgery and Buzzu00ae Digital O.R.
  • Multi-platform flexibility for planning and review on various devices.

Limitations

  • Current evidence is limited by relatively short follow-up periods and the need for larger, multicenter trials.
  • Some studies noted that conformity and gradient indices were not calculated for all targets, indicating a software limitation.
  • May result in increased volume of normal brain receiving radiation compared to older planning systems in some cases.
  • Formative usability evaluation was performed, but no summative usability evaluation has been conducted for RT Elements 4.5.

Based on reviews from: LA Vascular, accessdata.fda.gov, Life Healthcare, Novalis Circle, Brainlab, Capterra, Frontiers

Last updated: 2026-07-18

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Press & Coverage

FDA
RT Elements (4.5) FDA 510(k) Premarket Notification
Brainlab AG received FDA 510(k) clearance for RT Elements (4.5) on June 17, 2025, for radiation therapy treatment planning and dose optimization for various cranial and extracranial lesions. The software includes AI-based cranial tumor segmentation and supports multiple stereotactic radiosurgery applications.
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 article details the FDA approval of Brainlab Elements, a suite of software applications including version 4.5, which processes and analyzes medical image data to assist clinicians in planning surgeries and radiation treatments. It offers tools for image registration, segmentation, fibertracking, BOLD MRI mapping, and cerebrovascular image fusion, incorporating AI for tumor segmentation.
2023-07
MDPI (Cancers)
High-Dose Stereotactic Re-Irradiation of Recurrent High-Grade Gliomas: Clinical Outcome and Experience with AI-Based Target Volume Simulation
A study published in Cancers (Basel) in October 2025 evaluated the potential of AI in SRS planning using RT Elements 4.5 for generating GTVs in recurrent high-grade gliomas. The study concluded that high-dose SRS is a feasible salvage treatment and AI-based tumor segmentation shows promise for well-defined satellite recurrences.
2025-10
FlippingBook (ESTRO Abstract Book)
ESTRO 2026 - Abstract Book PART II
The ESTRO 2026 Abstract Book includes a study that retrospectively analyzed contrast-enhanced T1-weighted MRIs of patients treated with robotic SRS for brain metastases in 2024, utilizing the AI-based Cranial Tumor Segmentation algorithm from RT Elements 4.5. The study compared AI-generated Gross Tumor Volumes (GTVs) to reference Planning Target Volumes (PTVs).
2026-06
Brainlab
DICOM Conformance Statement RT Elements 4.5
Brainlab provides a DICOM Conformance Statement for RT Elements 4.5, detailing the image format and protocol for exchanging medical images and related information. This document is crucial for understanding the interoperability of RT Elements 4.5 within a healthcare IT environment.
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Videos

Product demos, reviews, and walkthroughs for RT Elements (4.5).

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Frequently Asked Questions

RT Elements (4.5) is designed as a computed-based software application for radiation therapy treatment planning and dose optimization, integrating into workflows that utilize linear accelerators (linacs). It processes co-registered DICOM image sets with segmented objects to create 3D structures and generate DICOM RT dose plans, which then control radiation delivery.
RT Elements (4.5) includes AI/ML features, notably for Cranial Tumor Segmentation, which assists in outlining and refining structures in patient image data for cranial and extracranial radiotherapy treatments. This AI algorithm was trained on MRI data from various clinical sites to support accurate target definition.
RT Elements (4.5) has received FDA 510(k) clearance (K250440) and CE marking, indicating its compliance with medical device regulations in the US and Europe. While specific HIPAA details aren't provided in the public FDA summary, as a medical device handling patient data, it must adhere to general controls provisions of the Act, including requirements for labeling and good manufacturing practice, which implicitly cover data handling standards.
While RT Elements (4.5) offers advanced automation for treatment planning, it is a software application intended to assist medical professionals, not replace them. The system's use is ultimately at the discretion of the user, such as radiation oncologists or medical physicists, who are responsible for clinical decision-making and ensuring the accuracy of the generated plans.
RT Elements (4.5) is part of Brainlab's suite of radiosurgery solutions, offering indication-specific tools for consistent and precise plan generation, including features like elastic image fusion and dose planning. It aims to provide automated processes and standardized workflows, and has shown comparable plan quality to previous versions like iPlan RT, sometimes with reduced total monitor units.
Specific pricing models for RT Elements (4.5) are not publicly disclosed and typically involve direct consultation with Brainlab sales representatives. However, similar to other specialized medical software, it is generally offered through licensing agreements or subscriptions, often bundled with support and integration services.

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