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Chain Restaurants Making Americans Fatter And Sicker Says Consumer Watchdog
America"s chain restaurants are making Americans fatter and sicker say consumer watchdog Center for Science in the Public Interest (CSPI) who
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Study To Follow Pregnant Women To Better Understand Causes, Early Signs Of Autism
NIH and the advocacy group Autism Speaks are enrolling 1,200 pregnant women who have other children with autism spectrum disorders to participate in a large study that aims to identify early signs of the condition and its possible causes, the Wall Street Journal reports. Women who participate in the study -- known as the Early Autism Risk Longitudinal Investigation, or EARLI, study -- will be monitored throughout their pregnancies, and their infants will be monitored until age three. The Centers for Disease Control and Prevention estimates that one in 150 children in the U.S. has an autism spectrum disorder, which includes autism, Asperger"s syndrome and pervasive developmental disorders. The study will focus on women who already have one child with an autism spectrum disorder because such women have a higher chance of having another child with the condition. Craig Newschaffer, the study"s lead investigator and a department chair at Philadelphia"s Drexel University School of Public Health, said, "By studying families who are already affected by autism, we feel we have the best chance at learning how genetics and environmental factors could work together to cause autism." Autism usually is characterized by social interaction and communication impairments, as well as unusual interests or behaviors. Although there is no cure for autism, its symptoms can be improved through therapy and medication, the Journal reports.According to Newschaffer, researchers throughout the study will collect blood and urine for DNA analysis. Samples also will be collected from the umbilical cord, placenta and meconium -- the infant"s first stool -- after birth. Infants born during the study will be provided with a series of developmental assessments, and older siblings with autism also could receive assessments to confirm their diagnosis (Corbett Dooren, Wall Street Journal, 6/9).
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Talecris Presents New Data From Phase III Studies Of A More Concentrated Formulation Of Prolastin(R) To Treat AAT Deficiency
Talecris Biotherapeutics presented results last week from two phase III studies assessing the safety, tolerability and pharmacokinetic comparability of a more concentrated formulation of Prolastin® (Alpha1-Proteinase Inhibitor [Human]) produced via a modification of the current manufacturing process that incorporates technological changes.
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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. 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 recommended that BSD pursue a Humanitarian Device Exemption (HDE) marketing approval and BSD followed FDA"s recommendation. The HDE approval of the BSD-2000 Hyperthermia System will authorize the commercial sale of the BSD-2000 in the United States. In addition, a product can have multiple HDE approvals and the company may decide to pursue additional HDE approvals for the BSD-2000 in the future. Cervical cancer is the second-most common cancer in women worldwide and a leading cause of death. It is the leading cause of death from cancer among women in developing countries. Researchers have predicted that developing countries could face a 75% increase in the number of cervical cancer cases in the next two decades due to growth and aging of the population. BSD is increasing the company"s representation in countries throughout the world, including the developing countries. BSD Medical


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