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BSD Medical submissions update

This article was originally published in The Gray Sheet

Executive Summary

BSD Medical will submit data on about 400 additional patients treated with its BSD-2000 hyperthermia system for cancer treatment as part of a formal response to FDA's request for more information on a PMA application submitted in May 2006, the firm says June 30. Most of the data supporting the original PMA submission came from European clinical studies (1"The Gray Sheet" Jan. 9, 2006, p. 15)
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