Taiwanese Approval Sought For BSD-2000 Hyperthermia System
BSD Medical has reported that Linden Bioscience, the company's exclusive Taiwan distributor, has submitted an MAA for the BSD-2000 hyperthermia cancer treatment system (BSD-2000) to the Taiwan FDA. Approval of BSD-2000 in Taiwan could occur as early as November 2013.
The BSD-2000 system, developed and patented exclusively by BSD, delivers localised therapeutic heating by applying radiofrequency energy. The system creates a central focusing of energy that can be electronically focused to target the shape, size and location of the tumour, thus providing dynamic control of the heating delivered to the tumour region. The device has humanitarian device exemption marketing approval from the US FDA for use in conjunction with radiation therapy for the treatment of cervical cancer patients who are ineligible for chemotherapy. The system also has CE mark approval for commercial sale in Europe.