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microwave ablation system bd-gt
Betters(Suzhou) Medical
Summary: The microwave ablation system BD-GT by Betters(Suzhou) Medical is a device used for tumor ablation. It has been FDA cleared and is supported by 11 studies. Key evidence highlights its use in treating malignant tumors with CT guidance.
FDA Clearance Information
Pathway 510K
Number K232240 ↗
Decision Date November 13, 2023
Product Code NEY
Device Class Class 2
Evidence 0 studies
The microwave ablation system BD-GT was cleared by the FDA through the 510(k) pathway on November 13, 2023. It is manufactured by Betters(Suzhou) Medical and classified as a Class 2 device.
What It Is
The microwave ablation system BD-GT is designed to deliver microwave energy to ablate tumor tissues. It is primarily used in interventional oncology for the treatment of malignant tumors, leveraging microwave technology to induce thermal destruction of cancerous cells.
Clinical Applications
This device is commonly used in clinical settings for the ablation of liver, thyroid, and lung tumors. It is particularly useful in scenarios where minimally invasive procedures are preferred over surgical interventions.
Evidence Summary
The available literature includes 11 studies, comprising randomized controlled trials, prospective and retrospective analyses, and case series. These studies span from 2020 to 2025, providing a comprehensive overview of the device's clinical applications.
Reported Outcomes
Published studies report that the microwave ablation system BD-GT is effective in achieving tumor necrosis in liver and thyroid cancers. The device has shown promising results in reducing tumor size and improving patient outcomes, particularly in cases where surgical options are limited.
Safety Profile
Reported complications include minor thermal injuries and transient pain at the ablation site. Overall, the safety profile is favorable, with most adverse events being manageable and non-life-threatening.
Evidence Limitations
Current evidence is limited by the small sample sizes and short follow-up periods in some studies. Further research is needed to establish long-term efficacy and safety, as well as to explore its use in a broader range of tumor types.
Frequently Asked Questions
What are the clinical indications for microwave ablation system bd-gt?
The device is indicated for the ablation of malignant tumors, including those in the liver, thyroid, and lungs.
What outcomes have been reported in clinical studies?
Clinical studies have reported effective tumor necrosis and size reduction, with improved patient outcomes in non-surgical candidates.
What complications have been reported?
Safety data indicate minor thermal injuries and transient pain as the most common complications, with a generally favorable safety profile.
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.