Women's Health Weekly
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Cancer Therapy
U.S. FDA grants IDE approval to enhance high-end cancer treatment system
January 13th, 2005
BSD Medical Corp. (BSDM) announced that the U.S. Food and Drug Administration (FDA) has granted an investigational device exemption (IDE) approval for several enhancements to the BSD-2000 cancer treatment system. BSD considers these enhancements crucial to the company's strategic marketing plan for future commercial introduction of the BSD-2000 product line. The approval includes software and hardware upgrades as well as modifications that will allow substantial cost reductions in producing the system. The phase III clinical trials that will be used to seek FDA premarketing approval for the BSD-2000 have already been concluded and the documentation...
Source: Women's Health Weekly (2005-01-13)
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