BSD Medical Submits 510(k) Premarket Notification for MicroThermX®-100 Microwave Ablation System

SALT LAKE CITY--(BUSINESS WIRE)--BSD Medical Corporation (AMEX:BSM) today announced that the company has provided its 510(k) Premarket Notification submission to the Food and Drug Administration (FDA) for the MicroThermX-100 Microwave Ablation System. The MicroThermX-100 Microwave Ablation System represents a major step into another market for BSD’s products. Clearance from the FDA of the 510(k) Premarket Notification submission is required before a Class II product can be sold commercially in the United States.
A 510(k) Premarket Notification includes documentation regarding compliance to applicable standards (UL, IEC, EMC, EMI, etc.), demonstration of substantial equivalence to predicate devices, documentation of required testing—including biocompatibility, shelf life, sterilization, software, hardware, and other required performance testing and documentation. The company’s 510(k) submission involves 1,251 pages.
BSD Medical’s product line includes systems that have been designed strategically to offer a complete range of thermal treatment products using microwave and RF (radiofrequency) technology. BSD is the leading developer of hyperthermia systems. Hyperthermia is used to treat certain types of cancer using heat to increase the effectiveness of companion radiation therapy. The MicroThermX-100 Microwave Ablation System represents an expansion of BSD’s products into new applications, as the MicroThermX-100 is designed as a stand-alone therapy that is used to ablate diseased tissue using heat alone.

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