Cervical cancer is one of the most commonly diagnosed cancers in women worldwide, and it is often treated with chemotherapy. However a small subset of those patients are unable to receive chemotherapy and therefore require other treatment approaches.
To that end, the US Food & Drug Administration has approved the BDS-2000 Hyperthermia System, which delivers localized heating through radio-frequency energy to bulky tumors. It is approved to be used with radiation therapy in those few thousand cervical cancer patients who are not eligible for chemotherapy.
The FDA's approval came by way of a humanitarian device exemption (HDE). Because the patient subset is so small--about 4,000--the HDE permits the maker to seek approval for the device without the kind of pivotal clinical trial evidence required of drugs. Instead, the device must demonstrate to regulators that it is safe and that it is likely beneficial.
Source: MedPageToday
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