BSD Medical has received FDA Humanitarian Device Exemption (HDE) marketing approval for its BSD-2000 Hyperthermia System for the treatment of cervical cancer.
The system uses focused electromagnetic energy to apply therapeutic heating to deep-seated tumors that are located more than 3 cm under the skin surface.
From the press release:
The BSD-2000 Hyperthermia System — developed and patented exclusively by BSD — delivers localized 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.
The BSD-2000 is approved 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. An HDE approval is obtained after a company has demonstrated the product’s safety and probable benefit for the treatment of a disease affecting fewer than 4,000 people in the United States every year.
The HDE only applies to the BSD-2000. The more advanced BSD-2000/3D and BSD-2000/3D/MR systems are not yet approved by the FDA for any kind of use within the United States.
Product page: The BSD-2000…
Flashback: BSD-2000 Hyperthermia System