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CSC Offers Medicare Secondary Payer Reporting To Health Plans
CSC (NYSE: CSC) announced that it has expanded its FirstPortfolio solution"s business process outsourcing (BPO) capabilities to include fully integrated Medicare Secondary Payer (MSP) reporting for healthcare payers. FirstPortfolio provides users with a collection of applications hosted and maintained by CSC.
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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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Is It Time To Consider A Role For MRI Before Prostate Biopsy?
UroToday.com - The prevailing view is that MRI has a limited role in the management of prostate cancer. Currently, the threshold for requesting a pre-treatment staging MRI is variable with most advocating this for only those classified as high risk localized prostate cancer, although some also advocate men with intermediate risk disease.
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Which? Warns Consumers Against Costly Genetic Tests

As the Lords Science Committee publishes its report on genomic medicine, Which? scientific policy adviser, Dr Rob Reid, says: "It has to be made clear to consumers that these tests are no more useful in predicting disease than knowledge of their family history and lifestyle. People could end up spending a lot of money on information* that is currently of little medical use." Notes *Genetic susceptibility tests sold direct to the consumer. Which? welcomes the publication of the House of Lords Science and Technology Committee"s wide ranging and detailed report on Genomic Medicine. In particular Which? is delighted that the report acknowledges the potential for consumer detriment caused by direct-to-consumer genetic susceptibility testing. Which? supports the recommendations that a voluntary code for the industry be established and that the UK government should support tougher classification of the tests at EU level. Peer reviewed scientific research has demonstrated that there is currently not enough evidence to show that genetic susceptibility tests are useful in measuring genetic risk for common diseases. However, Which? research found that 86% of all adults asked said they would take or consider taking further action if a genetic susceptibility test suggested they were more likely to develop a disease. Despite these findings there is currently little regulation of the sale of genetic susceptibility tests direct-to-the-consumer. Which?


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