BSD Medical Plans To File PMA For Cancer Therapy, Prepares Japanese Strategy
This article was originally published in The Gray Sheet
Executive Summary
BSD Medical plans to submit a PMA application by the end of the quarter for its non-invasive BSD-2000 tumor hyperthermia therapy system to treat cancer
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BSD Medical submissions update
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)
BSD Medical submissions update
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)
Hyperthermia payment boost
CMS proposes to raise reimbursement for procedure codes applicable to BSD Medical's cancer treatment systems by 86% in the 2008 hospital outpatient payment 1proposal released July 16, according to the firm. CMS will finalize the rates in November, to be effective Jan. 1. BSD markets hyperthermia systems, which kill cancer cells with focused heat and may improve the effectiveness of radiation and chemotherapy by increasing blood flow. The firm filed a response July 30 to questions FDA had on its March PMA submission for the BSD-2000 deep hyperthermia system, providing new data from a Dutch study with 12-year follow-up of patients treated with advanced cervical cancer (2"The Gray Sheet" Jan. 9, 2006, p. 15)...