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BSD Receives FDA Humanitarian Use Designation For The BSD-2000 Hyperthermia System
BSD Medical Corporation (NASDAQ:BSDM) announced that the U.S. Food and Drug Administration (FDA) has granted Humanitarian Use Device (HUD) designation for the company"s BSD-2000 Hyperthermia System for use in conjunction with radiation therapy for the treatment of cervical carcinoma patients who are ineligible for chemotherapy. This is the first of the two steps required to obtain Humanitarian Device Exemption (HDE) marketing approval, which requires BSD Medical to demonstrate the device"s safety and probable benefit in treating a disease or condition that affects fewer than 4,000 individuals in the United States per year. Now that FDA has granted the Humanitarian Use Designation for the BSD-2000, which confirms that the intended use population is fewer than 4,000 patients per year, BSD can file an HDE submission with the FDA. FDA has 75 days from the date of receipt of the HDE submission to grant or deny an HDE application. This period includes a 30-day filing period during which FDA determines whether the HDE application is sufficiently complete to permit substantive review. During this review, FDA may refine the indications for use which received HUD designation to finalize the indications for use for which HDE approval will be granted. This decision will be based on the data that are available to support the device"s HDE application. The company believes that the data previously submitted to FDA and reviewed by the agency in the company"s pending PMA application can be used to support the HDE approval, and that this previous review may expedite marketing approval for the BSD-2000.

Mice With Parkinson's Disease Gene May Point The Way To New Treatments
Scientists at Weill Cornell Medical College have developed a new mouse model of Parkinson"s disease (PD) that successfully reproduces the impairments of movement and the degenerative brain changes that occur in the human disease. Their research, performed in collaboration with investigators at Columbia University Medical Center, appears in the June 7 issue of the journal Nature Neuroscience.
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Scientists Identify Genetic Links To High Blood Pressure
An international scientific study involving researchers from the University of Glasgow has identified eight common genetic differences which may increase the risk of high blood pressure.
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Wiley-Blackwell Publishes Inaugural Issue Of LUTS (Lower Urinary Tract Symptoms)

Wiley-Blackwell, the scientific, technical, medical and scholarly publishing business of John Wiley & Sons, Inc (NYSE: JWa), (NYSE: JWb), has announced that the inaugural issue of its new journal, LUTS (Lower Urinary Tract Symptoms), is now live online. A new journal providing the latest clinical and basic science information in the field of neurourology, urodynamics, and urogynecology, LUTS is published for the Japanese Neurogenic Bladder Society, Korean Continence Society, and Taiwanese Continence Society. The journal features full color on its website, review articles, original articles, case reports, video articles on surgical techniques, ultrasound diagnosis, and videourodynamics. Editor-in-Chief of LUTS, Professor Osamu Yamaguchi said, "The journal seeks to provide timely communication to physicians and researchers. Helmed by an international editorial board, the journal will address the full spectrum of lower urinary tract dysfunctions." This first issue features an editorial by Professor Yamaguchi; as well as original papers in clinical and basic research, and a number of review articles. Wiley-Blackwell


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