The US Food and Drug Administration (FDA) has granted humanitarian device exemption marketing approval to BSD Medical’s BSD-2000 hyperthermia system
The BSD-2000 is approved for use along with radiation therapy for the treatment of cervical cancer patients.
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The hyperthermia system generates localised therapeutic heating by applying radiofrequency energy.
BSD Medical CEO Harold Wolcott said the approval provides clinicians with a new device for cervical cancer patients who are candidates for radiation therapy but ineligible for chemotherapy.
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