The US Food and Drug Administration (FDA) has granted a humanitarian device exemption (HDE) marketing approval to BSD Medical's BSD-2000 Hyperthermia System (BSD-2000).
The BSD-2000 Hyperthermia System applies radiofrequency (RF) energy and delivers localized therapeutic heat to solid tumors.
BSD Medical CEO Harold Wolcott said the HDE approval provides physicians a new clinical tool for cervical cancer patients who are candidates for radiation therapy but ineligible for chemotherapy due to patient related factors.
In order to optimize the deposition of heating energy into the targeted body tissues, BSD-2000 utilizes the adjustment of frequency, phase, and amplitude from multiple power sources, along with applicator selection and patient positioning.