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surface beacon transponders
Calypso Medical Technologies
Summary: Surface beacon transponders by Calypso Medical Technologies are used for electromagnetic tracking in radiotherapy. Key evidence highlights their role in improving treatment accuracy.
FDA Clearance Information
Pathway
510K
Number
K112841 ↗
Decision Date
February 16, 2012
Product Code
IYE
Device Class
Class 2
Evidence
0 studies
The surface beacon transponders were cleared by the FDA through the 510k pathway on February 16, 2012. Manufactured by Calypso Medical Technologies, they are classified as Class 2 devices.
What It Is
Surface beacon transponders are electromagnetic tracking devices used in radiotherapy to enhance precision by tracking tumor position in real-time. They are intended for use in tumor ablation procedures.
Clinical Applications
Commonly used in scenarios requiring precise tumor localization during radiotherapy, such as prostate cancer treatments, to ensure accurate targeting and minimize exposure to surrounding healthy tissue.
Evidence Summary
The available literature includes 7 studies, comprising various study types such as RCTs and retrospective analyses, conducted between 2017 and 2019. These studies evaluate the device's tracking accuracy and clinical utility.
Reported Outcomes
Published studies report that surface beacon transponders improve the accuracy of tumor tracking during radiotherapy, particularly in procedures like Deep Inspiration Breath Hold (DIBH) for breast cancer. They have been shown to enhance reproducibility and stability in patient positioning.
Safety Profile
Reported complications include potential interference from eddy current magnetic fields, which can affect tracking accuracy. However, no significant adverse events have been documented in the reviewed studies.
Evidence Limitations
The evidence is limited by the small number of studies and the lack of long-term outcome data. Further research is needed to explore the device's efficacy across different tumor types and treatment settings.
Frequently Asked Questions
What are the clinical indications for surface beacon transponders?
Surface beacon transponders are indicated for use in electromagnetic tracking during radiotherapy, particularly in tumor ablation procedures.
What outcomes have been reported in clinical studies?
Studies report improved accuracy in tumor tracking and patient positioning during radiotherapy, enhancing treatment precision.
What complications have been reported?
Reported complications include interference from magnetic fields affecting tracking accuracy, but no significant adverse events have been noted.
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.