SALT LAKE CITY, March 5, 2009 (GLOBE NEWSWIRE) -- BSD Medical Corporation (Nasdaq:BSDM) announced today that the company has filed a Humanitarian Use Device Petition for the BSD-2000 Hyperthermia System with the U.S. Food and Drug Administration (FDA). BSD Medical currently has a submission under review by the FDA seeking Pre-Market (PMA) approval for the BSD-2000. Due to the lengthy nature of the PMA review process, the length of time that the submission has been under review by the FDA, and the company's strong desire to bring the BSD-2000 to market as quickly as possible, the company has been working closely with FDA to seek the most expeditious pathway that can lead to marketing approval for the BSD-2000. FDA has recommended that BSD pursue a Humanitarian Device Exemption (HDE) marketing approval. BSD has evaluated FDA's recommendation and consequently filed the Humanitarian Use petition.
