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February 13, 2013News for medical technology professionals

  Top Story 
 
The odds of receiving an Inspectional Observation (483) or a subsequent Warning Letter have been sharply on the rise, and the seriousness of each remains high. How do you respond?
  Business & Market Trends 
 
  • Boston Scientific could pay about $75M for device tax this year
    The 2.3% medical device tax will cost Boston Scientific about $75 million this year, President and CEO Michael Mahoney said at a meeting with analysts Tuesday. The company hopes to overcome this and other challenges by streamlining its operations, building its worldwide presence and increasing its foothold in fast-growing technology markets, he said. MassDevice.com (Boston) (2/12) LinkedInFacebookTwitterEmail this Story
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  International Developments 
  
Eucomed represents the medical technology industry in Europe. Our mission is to make modern, innovative and reliable medical technology available to more people. AdvaMed and Eucomed partner on issues of mutual interest.
  • CurveBeam gains EU approval for foot and ankle CT scanner
    European regulators have granted CurveBeam approval to market its PedCAT CT scanner, which is used to generate 3D foot and ankle images during weight- and nonweight-bearing evaluations for preoperative planning and other applications. The device uses cone-beam technology, which allows it to deliver a lower radiation dose than conventional CT systems and be small enough to fit in a doctor's office. MedGadget.com (2/12) LinkedInFacebookTwitterEmail this Story
  • Sweden aligns medtech software policies with EU rules
    The Swedish Medical Products Agency has released new guidance outlining its process for regulating standalone software classified as medical devices in the country. The revised guidance is intended to clear up "remaining ambiguities" involving the regulation of such products as well as align it with the European Commission's rules on medtech software. Clinica (subscription required) (2/11) LinkedInFacebookTwitterEmail this Story
  Science & Health 
  Emerging Technologies 
  • Advanced heart stent from Boston Scientific debuts in Europe
    Boston Scientific is launching its Promus PREMIER coronary stent, which is made of platinum chromium alloy, in Europe. The device, which is not yet available commercially in the U.S. and Japan, releases the drug everolimus and is coated with a fluorinated co-polymer to give it flexibility. MedGadget.com (2/12) LinkedInFacebookTwitterEmail this Story
  Industry Service Providers 
  Government & Regulatory 
  • IVD payment bills top AdvaMedDx's agenda
    The new AdvaMedDx board headed by BD CEO Vincent Forlenza is setting its sights on two House bills that would promote changes in the payment systems for diagnostics in the U.S. The bills are the MODDERN Cures Act and the Improving Diagnostic Innovations Act, or HR 6446. Clinica (subscription required) (2/12) LinkedInFacebookTwitterEmail this Story
AdvaMed News 
  • Medical Device Tax Workshop
    Wednesday, March 13 -- Thursday, March 14
    Sheraton Crystal City, Arlington, Va.

    Join tax professionals in discussing how to implement the new medical device 2.3% excise tax. Medical device tax experts discuss how to implement these tax changes. Interact in educational sessions and collaborative lessons, and discuss with other industry affiliates concerns with the medical device excise tax. Medical device tax leaders navigate you through these tax changes by identifying key issues such as: identifying taxable medical devices; taxable and non-taxable uses; combination products; bundled services; exemptions; reporting; exclusions; rebates; payment; penalties; accounting systems; and ruling guidance. Visit MTLI online for more information. LinkedInFacebookTwitterEmail this Story
  • Join the AdvaMed-MTLI LinkedIn group!
    Build close relationships with member companies, both small and large, and receive an intimate understanding of the key issues affecting innovation, access and the bottom line. Interact in discussions that leverage the leadership and expertise of the medical technology industry. This social group is full of key stakeholders, influencers and industry thought leaders as well as regulatory and policy experts from the FDA and CMS. Aside from practical learning opportunities, this LinkedIn group provides the premier opportunity to network with key players from virtually every aspect of the industry. Link to the AdvaMed MTLI LinkedIn group page. LinkedInFacebookTwitterEmail this Story
 
Learn more about AdvaMed ->About AdvaMed | Join | Courses | Events | Newsroom

 
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Engineer, Process DevelopmentArthroCare CorporationIrvine, CA
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Legal Counsel IIMedtronic, Inc.Minneapolis, MN or Washington, DC, United States
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  SmartQuote 
Several excuses are always less convincing than one."
--Aldous Huxley,
British author


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