(Elements) Retreatment Review

by Brainlab AG  · Based in Germany → — Innovation for healthcare.
Neurosurgery Oncology Radiology
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Not publicly disclosed
Regulatory Status Disclosed

Overview

Elements Retreatment Review, part of Brainlab’s Elements Solutions for Retreatment Analysis, is an AI-powered software tool designed to support follow-up and decision-making processes, and facilitate retreatment planning for patients with multiple brain metastases. It provides a comprehensive, color-coded overview of new and previously treated metastases, integrating prior treatment information with new follow-up scans to assess current patient status. The solution aids in planning optimal retreatment strategies by automatically considering previous Planning Target Volumes (PTVs) during new arc placement in the dose plan. It also features advanced AI-powered tumor segmentation for fast and easy delineation of recurring or new lesions on contrast-enhanced T1-weighted MRI scans.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Comprehensive overview of prior and current treatments for brain metastases
  • Color-coded display of previous and new targets
  • Dose overlays of all previously delivered doses with optional weighting for potential cell repair
  • Dose-volume histograms (DVHs)
  • Automatic calculation of maximum doses to all organs at risk (OARs)
  • Advanced AI-powered tumor segmentation for cranial tumors on contrast-enhanced T1-weighted MRI scans
  • Automatic consideration of previous PTVs during new arc placement
  • Supports follow-up and decision-making processes
  • Facilitates retreatment planning
  • Software-only device, controlled via mouse and keyboard

Use Cases

  • Retreatment planning for patients with multiple brain metastases
  • Assessing current patient status by aligning prior treatment information with new follow-up scans
  • Delineation of recurring or new lesions using AI-powered segmentation
  • Optimizing radiation treatment strategies for new and recurring lesions
  • Reviewing and analyzing dose distribution for radiation therapy

What Physicians Need to Know

Brain MRI/CT Analysis
Elements Retreatment Review leverages advanced AI-powered tumor segmentation for fast and easy delineation of recurring or new lesions on contrast-enhanced T1-weighted MRI scans. It aligns all prior treatment information with new follow-up scans, providing a comprehensive, color-coded 3D overview of new and previously treated metastases. The software also generates dose overlays of all previously delivered doses, dose-volume histograms (DVHs), and automatically calculates maximum doses to organs at risk (OARs).
Neurodegenerative Disease Screening
While primarily focused on retreatment planning for brain metastases, the underlying 'Elements AI Tumor Segmentation' technology can delineate cranial tumors. The broader Brainlab Elements suite, of which Retreatment Review is a part, includes applications like Fibertracking for visualizing white matter tracts based on Diffusion Weighted Imaging (DWI) and BOLD MRI Mapping for analyzing blood oxygen level dependent data, which are relevant for comprehensive neurological assessment.
ASPECTS Score Automation
The tool provides detailed dose review features, including the analysis of isodose lines, dose-volume histograms, and dose comparison and summation. It automatically calculates maximum doses to all organs at risk (OARs), supporting critical decision-making for retreatment planning by explicitly considering cumulative dose and constraining previously treated foci as OARs. This level of detailed analysis for critical brain structures aligns with the principles of assessing neurological impact, similar to ASPECTS for stroke.
Mobile Notification System
Brainlab Elements offers multi-platform flexibility, allowing clinicians to work online on preferred devices, including iPad and iPhone, or offline on a workstation. This enables planning and review on mobile devices, supporting clinicians in various settings such as meetings, tumor boards, and home offices.
Physician Tip

Elements Retreatment Review streamlines the complex follow-up and decision-making process for patients with multiple brain metastases by providing a comprehensive, color-coded overview of prior treatments and current patient status. Physicians can benefit from advanced AI-powered tumor segmentation for efficient delineation of new or recurring lesions and the automatic consideration of previous planning target volumes (PTVs) during new arc placement, facilitating optimal retreatment strategies and minimizing unexpected dose escalation in adjacent high-dose regions.

The software automatically aligns all prior treatment information created within RT Elements or imported from third-party systems. It is a key application within the broader Brainlab Elements suite, which includes modules for image fusion, contouring, and advanced visualization, ensuring seamless integration into existing radiotherapy workflows and connecting various clinical subspecialties.

Details

Category Neurology AI, Oncology AI, Radiology & Imaging AI
Pricing Not publicly disclosed — Contact vendor for pricing information.
DeploymentOn-premise (software-only device)
Compliance
BAA AvailableUnknown AI-estimated
HIPAA Compliant Yes AI-estimated
FDA Status 1 AI-estimated

The device, K250440, received 510(k) clearance on June 17, 2025, for use in radiation treatment planning for stereotactic, conformal, computer-planned, Linac-based radiation treatment for cranial, head and neck, and extracranial lesions.
Integrations
EHR Not specified
Specialties Neurosurgery, Oncology, Radiology

What the Web Says

Brainlab's (Elements) Retreatment Review is a software application designed to assist clinicians in managing recurrent multiple metastases, particularly in the brain. It provides a comprehensive overview of previous treatments and new lesions, supporting complex follow-up and decision-making processes for re-treatment planning. The software aims to streamline workflows, enhance planning accuracy, and improve patient care by offering advanced visualization and dose summation capabilities.

Overall: Positive

Strengths

  • Provides a comprehensive overview of previous treatments and new lesions for recurrent metastases.
  • Supports complex follow-up and decision-making for re-treatment planning.
  • Offers 3D visualization of previously treated and new metastases, along with review options for summed doses of prior treatment plans.
  • Helps document repeated courses of radiosurgery, allowing matching of different treatments within one picture and integration of new MRI data.
  • Clinically validated for effectiveness in pre-planning for surgeries and radiotherapy, meeting safety and performance requirements.
  • Can reduce planning time significantly, potentially democratizing advanced treatments for smaller clinics.

Limitations

  • Effectiveness is dependent on proper hardware and user expertise.
  • AI features rely heavily on input image quality and user-defined parameters.
  • No specific contraindications, but usage is limited to situations where medical professionals need to interpret and manipulate image data, not for direct diagnosis or creating physical replicas.
  • Limited public reviews from independent sources like G2, Capterra, or Reddit, making it difficult to gauge widespread user sentiment outside of clinical studies and company-provided information.

Based on reviews from: Brainlab, accessdata.fda.gov, PMC, Medical News Observer, YouTube, Frontiers, PubMed

Last updated: 2026-07-18

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Press & Coverage

Brainlab
The latest version of RT Elements is now ready for roll-out in the US - Brainlab
Brainlab announced the FDA clearance and US rollout of its newest RT Elements version, featuring the 'Elements Retreatment Review' application for managing recurrent multiple metastases. This follows CE approval and initial European installations in May 2023.
2023-07
FDA
K250440 - 510(k) Premarket Notification - FDA
This FDA premarket notification details the clearance of Brainlab AG's RT Elements, which includes the (Elements) Retreatment Review, Elements Segmentation, Elements AI Tumor Segmentation, Elements SmartBrush, and Elements Object Management RT.
2026-06
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 entry lists Brainlab Elements as a suite of software applications for processing and analyzing medical image data to assist clinicians in planning surgeries and radiation treatments, including the (Elements) Retreatment Review.
2023-07
Novalis Circle
Interview with Professor Cordula Petersen on Elements Retreatment Workflow
Professor Cordula Petersen discusses how Brainlab Elements Retreatment Review software aids clinicians in managing recurrent multiple brain metastases by providing a comprehensive overview of previous treatments and new lesions.
2024-02
RadMag
Pru00e4zise, individuell, schonend - RadMag
This German article highlights how Brainlab's Elements Retreatment Review software provides physicians with an overview of all previous radiosurgical treatments for brain metastases and the current patient status, supporting decision-making for necessary follow-up treatments.
2025-03
Constat
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 & - Constat
This entry details the FDA 510(k) clearance K250440 for Brainlab's RT Elements, which includes the (Elements) Retreatment Review, and provides information on the software's components and AI/ML algorithm for cranial tumor segmentation.
2026-07
accessdata.fda.gov
June 17, 2025 Brainlab AG Sadwini Suresh QM Consultant Olof-Palme-Str. 9 Munich, 81829 Germany Re: K250440 Trade/Device Name: R - accessdata.fda.gov
This FDA document confirms the 510(k) clearance for Brainlab's RT Elements, which are computer-based software applications for radiation therapy treatment planning, including the Retreatment Review feature, for various lesions.
2025-06
BEUDAMED
Brainlab Elements Guide XT, Guide 3.0 - BEUDAMED
This regulatory entry from BEUDAMED lists Brainlab Elements Guide XT and Guide 3.0, and mentions the (Elements) Retreatment Review as part of the Brainlab Elements suite, with a decision of 'Substantially Equivalent'.
2022-04

Videos

Product demos, reviews, and walkthroughs for (Elements) Retreatment Review.

View all on YouTube

Frequently Asked Questions

AI can rapidly analyze vast amounts of patient data, including historical treatments, imaging, and genomic information, to identify patterns and predict potential outcomes for retreatment. This accelerates the review process and provides physicians with data-driven insights to inform their decisions.
The AI system is designed with robust data anonymization and encryption protocols to protect patient health information (PHI). It operates within a secure, compliant framework, adhering to all relevant healthcare data privacy regulations like HIPAA.
AI offers unparalleled speed and consistency in data analysis, reducing the time spent on manual chart review and minimizing human error. While human expertise remains crucial, AI can process and synthesize information from thousands of similar cases, providing a broader evidence base than a single physician might access.
Pricing models often vary, ranging from subscription-based fees per review or per user, to tiered pricing based on the volume of cases processed. It's important to consider the total cost of ownership, including integration, training, and ongoing support, when evaluating the investment.
AI's recommendations are based on the data it was trained on and may not account for highly unusual or novel patient presentations not present in its dataset. Physicians should always exercise their clinical judgment, especially in ambiguous cases, as AI lacks the ability to understand complex human nuances or ethical considerations.

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