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BSD answers FDA’s questions on MicroThermX

This article was originally published in Clinica

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Executive Summary

BSD Medical has provided further information on the 510(k) application for its Phase II MicroThermX microwave ablation system (MTX-180), as requested by the US FDA. The MTX-180 uses microwave energy to ablate soft tissue via a single-patient-use disposable antenna, and is designed to treat cancer. BSD originally filed the application in March, but the agency replied with questions earlier this month. Salt Lake City, Utah-based BSD described this as a “routine part” of the review process, and now says it is optimistic about the outcome of the application. The company’s Phase I MicroThermX Microwave Ablation System (MTX-100) received 510(k) approval in September 2008.

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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