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Virus Filters For Medical Diagnosis
Providing reliable evidence of viruses in human blood presently requires time- and labor-intensive molecular-biological procedures. Established methods are particularly hard pushed to produce evidence when the viral burden is very low, for example during a phase of therapy. This could soon change. While developing new types of micro-pumps without movable parts, scientists from the Fraunhofer Institute for Biomedical Engineering IBMT came across an unexpected phenomenon: stable turbulence structures formed in the microscale pump channels. The nano- and microparticles actually intended to verify the pump effect accumulated in large quantities in the channels. The vortex patterns completely filled the whole microchannel, creating a virtually 100% trap for the particles that followed the generated flow profile, although there is a very large cross-section to flow through. "The development of flow vortices is nothing unusual on the macroscopic scale. However, in microchannels the flow lines almost run in parallel," explains Richard Stein from the IBMT. "The question, therefore, was, how is it possible for vortices to be formed from this which were sufficiently stable and effective for the concentration of nanoparticles?"
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MOC-Etomidate: Retaining Beneficial Anesthetic Properties, Reducing Dangerous Side Effects
Researchers at Massachusetts General Hospital (MGH) have developed a new anesthetic agent, which they think could be a breakthrough in the quest to discover drugs that retain beneficial anesthetic properties while reducing unwanted and occasionally dangerous side effects.
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Physicians Wait For Health IT Guidelines, Officials Want 'Every Doctor's Office' Online
Physicians are still waiting for clear cut rules for how they must use health information technology in order to be eligible for economic stimulus-funded incentives, American Medical News, a publication of the American Medical Association, reports. The publication notes that (the $2 billion) "incentive money will directly address the use of EMRs, not the purchase of the systems." The sole, ambiguous requirement - that doctors must make "meaningful use" of the technology - will be defined by year"s end. But, industry consultants say doctors can and should get a head start on the governments expectation that they"ll be able to adopt the technology by 2011. Practices can expect requirements to include e-prescribing, certification through a government-approved certifying body, quality reporting, and the ability of one system to exchange information with others (Dolan, 6/15).
Medical Devices

European Medicines Agency Recommends First Marketing Authorisation For Cell-Based Medicine That Repairs Femoral Condyle Cartilage Defects

The European Medicines Agency has recommended the first marketing authorisation for an advanced therapy medicinal product, following a positive opinion from the Agency"s Committee for Advanced Therapies (CAT) and the Committee for Medicinal Products for Human Use (CHMP). ChondroCelect, from TiGenix NV, is a cell-based medicine that is used to repair defects in the cartilage of the femoral condyle (the end of the thighbone) in the knee. It consists of chondrocytes (cartilage-forming cells) that are taken from a healthy region of the patient"s cartilage, grown outside the body, and then re-implanted during surgery. ChondroCelect is the first product to benefit from the new legal and regulatory framework for advanced therapy medicinal products (Regulation (EC) No 1394/2007). This framework is designed to ensure the free movement of advanced medicines within the European Union (EU), to facilitate their access to the EU market, and to foster the competitiveness of European pharmaceutical companies in the field, while guaranteeing the highest level of health protection for patients. The CAT, a multidisciplinary committee bringing together some of the best available experts in gene therapy, somatic cell therapy and tissue engineering, assessed the scientific data provided to support the marketing authorisation application for ChondroCelect. In line with the procedure set out by the Regulation on advanced therapy medicinal products, the CAT prepared a draft opinion, which was forwarded to the CHMP. On the basis of this opinion, the CHMP adopted its recommendation that ChondroCelect be granted marketing authorisation on 25 June 2009. As part of the application, the CAT and the CHMP have required the company to submit a risk management plan with a series of measures, including further studies to ensure that the medicine"s efficacy and safety are followed up in a robust manner once it is on the market. The scientific recommendation will now be forwarded to the European Commission for the adoption of a legally binding marketing authorisation decision. Notes 1. A summary of opinion for ChondroCelect with the full indication is available here. 2. The European Public Assessment Report (EPAR) for ChondroCelect with detailed information on the scientific assessment of the medicine will be published once the European Commission has adopted a marketing authorisation decision. 3. More information about the Agency"s work in the field of advanced therapy medicinal products can be found here. 4. A question-and-answer document on the regulation of advanced therapy medicinal products is available here. EMEA


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