BSD sets sights on US 510(k) for MicroThermX:
This article was originally published in Clinica
Executive Summary
BSD Medical has begun preparations to gain US FDA 510(k) clearance for its MicroThermX 100 system for treating cancer via precision-guided microwave thermal ablation. The Salt Lake City, Utah company, which already sells precision-guided radiofrequency (RF) and microwave systems for use in conjunction with chemotherapy and/or radiotherapy, said that the new product is intended to broadly expand its market by also targeting cancers that can be treated by heat alone. Another of the firm's RF/microwave heating cancer treatment systems, BSD-2000, is pending premarket approval (PMA) clearance in the US.