BSD Medical's premarket application accepted for filing by FDA

By Elaine Rigoli

Tampa, Fla., May 22 - BSD Medical Corp.'s premarket approval application for the BSD-2000 cancer treatment system has been accepted for filing and review by the Food and Drug Administration.

Acceptance for filing indicates that the FDA considers the company's application to be complete and warrants full review of the data needed to assess the safety and efficacy of the BSD-2000.

The BSD-2000 is used to focus therapeutic radiofrequency/microwave heating in cancerous tumors in an effort to kill cancer cells and improve the response of radiation therapy, the company said in a news release.

Applying principles also used in deep-space radio telescopes and advanced phased-array communications, the BSD-2000 delivers precision-directed RF energy into cancerous tumors, the release said.

Salt Lake City-based BSD Medical produces systems that deliver precision-guided heat into diseased sites in the body for the treatment of cancer and other conditions.

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