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 July 21, 2008 Volume 34, Number 29 

GAO: Prior Authorization For Medicare Imaging Scans Should Be On The Table
The Government Accountability Office recommends that CMS consider adopting a gatekeeper "prior authorization" payment policy to curtail the rapid growth of Medicare spending on imaging services.    READ MORE>>
FzioMed Oxiplex Anti-Adhesion Gel Not Approvable For Spine Surgery – Panel
FzioMed's Oxiplex/SP anti-adhesion gel for spine surgery is "not approvable" due to its failure to adequately demonstrate a statistically significant treatment benefit in the sponsor's randomized, pivotal trial, according to FDA's Orthopaedic and Rehabilitation Devices Panel.    READ MORE>>
St. Jude Medical Gains Market Share, Increases Outlook On Strong ICD Sales
St. Jude Medical took another two to three points of global implantable cardioverter defibrillator market share in the first half of the year, on the back of 40 ICD and pacemaker product launches in the past two years, the company said July 16.    READ MORE>>
 
 
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    		•  Cross-Center CDRH Matrix Goes Live After Six Months Of Ground Work
     
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    		•  Quality System Reg Could Be Revised To Incorporate Customer Feedback
     
     
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    		•  Theragenics Gets Complementary Product Injection With NeedleTech Buy
     
     
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    		•  People In Brief
     
     
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    		•  Medicare Bill Becomes Law: Industry Focuses On What Didn’t Make the Cut
     
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    		•  Medicare Proposal Pours Cold Water On Heat-Based Back Pain Therapy

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    		•  Senate panel appropriates $2.04 billion for FDA
     
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    		•  Advanced Bionics/FDA settlement
     
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    		•  Bone density meters get easier path to market
     
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    		•  CT scan alert
     
     
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    		•  Financings In Brief
     
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    		•  Biomet Looks Abroad For Revenue Growth In Fiscal 2008
     
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    		•  Abbott Reports Xience Stent Launch Off To A Good Start
     
     
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    		•  Some Payments Permissible Under Foreign Corrupt Practices Act
     
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    		•  Chart: Global Harmonization Task Force Standardizes Regulatory Terms
     
     
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    		•  Chart: FDA's June 2008 Clearances of 510(k)s
     
     
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    		•  Chart: FDA Warning Letters Released the Weeks of June 30 - July 14
     
     
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    		•  Expectations For Artificial Disc Trials Challenge Market Hopefuls
     
     
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    		•  Featured Report: The Art Of Selecting Outsourcing Partners In China
     
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    		•  Featured Event: "Medical Device Investor Day" Symposium and Annual "Investment In Innovation (In3) East" Conference
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