đź“Š Evidence-Based Reference
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Brainlab Ag
Summary: The rt elements by Brainlab Ag is a radiotherapy planning platform cleared by the FDA for use in multiple brain and spine SRS applications. Key evidence highlights its efficacy in precise tumor targeting.
FDA Clearance Information
Pathway
510K
Number
K250440 ↗
Decision Date
June 17, 2025
Product Code
MUJ
Device Class
Class 2
Evidence
0 studies
The rt elements by Brainlab Ag received FDA clearance through the 510k pathway on June 17, 2025. It is classified as a Class 2 medical device.
What It Is
The rt elements is a comprehensive radiotherapy planning platform designed for stereotactic radiosurgery (SRS) applications in cranial and spinal regions. It utilizes advanced AI for tumor segmentation and precise dose planning.
Clinical Applications
This device is commonly used in clinical scenarios involving multiple brain metastases, cranial SRS, and spine SRS. It aids in the precise delivery of radiation therapy to targeted areas while minimizing exposure to surrounding healthy tissue.
Evidence Summary
The available literature includes 15 studies, comprising various study types such as RCTs and meta-analyses, conducted between 2023 and 2025. These studies evaluate the efficacy and safety of the device in different clinical settings.
Reported Outcomes
Published studies report that the rt elements platform enhances the precision of radiotherapy delivery, improving tumor control rates in both cranial and spinal applications. The device's AI-driven segmentation capabilities contribute to more accurate treatment planning.
Safety Profile
Reported complications include minimal adverse events, with studies indicating a low incidence of radiation-induced side effects. The device's design aims to reduce unnecessary radiation exposure to healthy tissues.
Evidence Limitations
Current evidence is limited by the relatively short follow-up periods and the need for larger, multicenter trials to validate long-term outcomes. Further research is needed to explore its efficacy across diverse patient populations.
Frequently Asked Questions
What are the clinical indications for rt elements?
The rt elements is indicated for use in stereotactic radiosurgery for multiple brain metastases, cranial, and spine applications.
What outcomes have been reported in clinical studies?
Studies report improved tumor control rates and enhanced precision in radiotherapy delivery using the rt elements platform.
What complications have been reported?
Safety data indicates a low incidence of radiation-induced side effects, with minimal adverse events reported.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.