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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.
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Both Phase III Pivotal Trials Begin Enrollment In May 2009; Reinforces Lilly's Commitment To Alzheimer's Disease And Biotech Product Research
Eli Lilly and Company (NYSE: LLY) announced it will begin enrolling
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Discovery Of Gene Mutation Responsible For Hereditary Neuroendocrine Tumor
University of Utah researchers and their colleagues have identified the gene that is mutated in a hereditary form of a rare neuroendocrine tumor called paraganglioma (PGL). The gene, called hSDH5, is required for activation of an enzyme complex that plays a critical role in the chemical reactions that take place within cells to convert biochemical energy into usable energy. This study is published in the journal Science
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More Progress Still To Be Made On Mental Health

Commenting on the final biennial report from the Mental Health Act Commission released by the Care Quality Commission, Mental Health Network director Steve Shrubb said: "While the Commission rightly acknowledges that often very vulnerable people are looked after effectively and with care, we know there is more to do to make this the norm across all services. "The commission is also right to highlight the high number of community treatment orders and we agree that we need a more detailed understanding of how they are being used. "The Mental Health Network has been calling for some time for the mandatory training and accreditation scheme for all staff who may be engaged in restraint practices to be set up as soon as possible. "We are also working with the department of health among others to develop an acute pathway declaration which will set out the kind of support people can expect along with a national plan to implement it." Notes The Mental Health Network represents the majority of mental health trusts. It was launched in spring 2007 to provide a distinct voice for providers of NHS mental health services. The NHS Confederation


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