FDA approves BSD-2000 (BSD) for use with Cervical Cancer treatment

The FDA has given Humanitarian Device Exemption (HDE) marketing approval for the BSD-2000 Hyperthermia System, from BSD Medical Corporation, for use in conjunction with radiation therapy for the treatment of Cervical Cancer patients who normally would be treated with combined chemotherapy and radiation but are ineligible for chemotherapy due to patient related factors. The HDE approval authorizes the commercial sale of the BSD-2000. The BSD-2000 Hyperthermia System delivers localised therapeutic heating (hyperthermia) to solid tumors by applying radiofrequency (RF) energy. The BSD-2000 creates a central focusing of energy that can be electronically focused to target the shape, size, and location of the tumor, thus providing dynamic control of the heating delivered to the tumor region. This method of therapeutic heating utilizes the adjustment of frequency, phase, and amplitude from multiple power sources, along with applicator selection and patient positioning, to optimize the deposition of heating energy into the targeted body tissues.