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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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Washington Post Details Six Senators To Watch On Health Care; Politics Of Fear Gain Prominence
The battle over health care reform will happen in the Senate, even though President Obama keeps getting all the attention, The Washington Post"s The Fix reports.
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Can Virtual Humans And Micro-lungs Bring The End Of Animal Research?
Science fact meets science fiction as experts imagine a future without animal research and how we might get there - at this year"s Cheltenham Science Festival.
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Preventing Spread Of Infectious Diseases Is Everyone's Responsibility

According to a report published recently, we must all share responsibility for preventing the spread of diseases such as swine flu, SARS, avian influenza, diarrhoeal and skin diseases, and even the common cold. The swine flu scare has prompted some to say that we are over-reacting but it is important to look at the bigger picture - because the next new pathogens are always just around the corner. The regular emergence of new pathogenic strains, and their unpredictable behaviour, means that sustained investment in effective strategies of mitigation and containment make absolute sense. But if infections are to be kept in check, there needs to be a fundamental change in our approach to hygiene, with more emphasis being placed on empowering families to take on this responsibility. Professor Sally Bloomfield of the London School of Hygiene & Tropical Medicine and one of the report"s authors, comments: "Although antibiotics and vaccines have given us unprecedented ability to prevent and treat killer diseases, hygiene is still fundamental to winning the battle against infectious disease in both developed and developing countries - and that"s a job for all of us. This is not about shifting responsibility, it"s about facing reality". The report, published by an expert group for the International Scientific Forum of Home Hygiene, indicates that a significant proportion of global infectious disease could be prevented through improved hygiene practice coupled with the provision of adequate water and sanitation. One of its key conclusions is that, if the burden of these diseases is to be contained in a manner which is economically sustainable, it must be a responsibility which is shared by all of us. Information around hygiene is still too fragmented and confusing, however. For example, advice on preventing spread of colds and flu is very different from that on preventing diarrhoeal diseases. What is needed, argue the authors, is a less agency-centred approach, and one that is more family-centred, empowering parents to better protect themselves and their families against infection. Dr Elizabeth A Scott, also a co-author comments: "The key to getting people to change their behaviour is to find a way to make hygiene behaviour more appealing and relevant by realigning it with other aspects of healthy living such as diet and exercise. People also need to understand that they can be proactive in protecting themselves and reducing their risk of acquiring an infection in their everyday lives". If we can prevent infections through good hygiene, we can also reduce the amount of antibiotics we need to prescribe, according to co-author Professor Martin Exner . Overprescription of antibiotics is the main cause of antibiotic resistance, which is threatening our ability to treat infections effectively when they occur. In developing countries, the huge burden of hygiene and sanitation-related infectious diseases continue to be the most critical public health threat. Says co-author Professor KJ Nath: "Much of the focus in developing countries is on investment in community water supply and sanitation in order to meet the Millennium Development Goals, but if the health benefits are to be realised, programmes of hygiene promotion must be implemented in conjunction with improvements in water and sanitation". Last week"s report on the state of the NHS called for greater emphasis on "disease prevention strategies" as a means to reduce pressure on NHS budgets. Infection prevention will be particularly important for the ever-increasing ageing population, for whom infectious diseases can have much more serious consequences which require hospitalisation. All of these trends underline the need for greater collective effort in better standards of hygiene. Says Professor Bloomfield: "In the current climate where infectious disease agents and our immunity to these agents are constantly changing, we need to return to the "not-so-good old days" when our parents and grandparents knew that protecting themselves and their families against infectious diseases was part of their responsibility and an important part of daily life". Gemma Howe London School of Hygiene & Tropical Medicine


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