Life Sciences Newsbriefs: Week Of June 20, 2011
Mondaq Business Briefing › United States Law Articles in English (2011)
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Life Sciences Newsbriefs: Week Of June 20, 2011
CONTENTS:
Medical Devices Drugs & Biologics Food & Dietary Tobacco Medical Devices Critics say analyses of 510(k) process aren't science-driven As the FDA considers changes to the 510(k) process for clearing medical devices, several analyses of the process have been released. Some critics say conclusions of such studies are being driven by bias rather than science. Ralph Hall, a med-tech executive and 510(k) process study author, said questions regarding the analyses are "a surrogate for the philosophical debate about the balance FDA must strike" and that the agency "has to balance safety versus access to new products and innovation." Data indicate high rates of double CT scans in many U.S. hospitals Federal data indicate that hospitals performed 76,781 double chest scans on Medicare patients in 2008. Of 3,094 hospitals, 618 administered double scans on at least 10% of Medicare recipients while 94 did on at least 50% of the beneficiaries, according to federal data. Current industry guidelines say a double scan is appropriate only when diagnosing a tear in the wall of the aorta or examining arterial plaque buildup. Chinese university to send medical tech to U. of Minnesota for evaluation The University of Minnesota's Carlson School of Management has signed a deal that will allow university students at Medical Industry Valuation Laboratory to evaluate medical technologies from the University of Shanghai for Science and Technology based on intellectual property and user valu...See the full content of this document
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