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BSD Medical approvals

This article was originally published in The Gray Sheet

Executive Summary

Firm will submit PMA in 2004 for BSD-2000 deep cancer hyperthermia treatment system currently undergoing IDE clinicals for treatment of multiple cancers, including those in the pelvic region. Upgraded versions of the firm's BSD-500 systems received approval Oct. 10 to supplement an initial PMA approval for superficial and interstitial treatment of near-surface cancers. Priced at $175,000-$250,000, the new models' touch-screen displays allows better control and operation, according to the firm. BSD primarily will market the BSD-500 as a complement to installed interstitial brachytherapy systems...

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