BSD Medical moves closer to HDE for cervical cancer treatment
This article was originally published in The Gray Sheet
Executive Summary
BSD Medical's BSD-2000 hyperthermia system receives a humanitarian use device designation from FDA for use in conjunction with radiation therapy for cervical carcinoma patients ineligible for chemotherapy, the firm announces May 18. The HUD designation, which confirms a target population of fewer than 4,000 U.S. patients annually, is the first step toward seeking Humanitarian Device Exemption marketing approval (1"The Gray Sheet" March 16, 2009, p. 15)