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November 7, 2012News 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 
  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.
  • 5 U.K. medtech firms gain a share of Biomedical Catalyst fund
    A group of 22 small and medium enterprises received about $36.7 million in financing from the Biomedical Catalyst, a $288 million fund that the U.K. government introduced earlier this year to fuel growth in the biotech sector. Five of those SMEs are focused on medical devices: Ixico, OJ-Bio, Glide Pharmaceutical Technologies, QuantuMDx and ELISHA Systems. Clinica (subscription required) (11/6) LinkedInFacebookTwitterEmail this Story
  Science & Health 
  Emerging Technologies 
  • Testing is under way for Aeris' emphysema device
    The AeriSeal System designed to treat emphysema is undergoing a late-stage clinical study in the U.S., and has been used for the first time in this country at the University of Alabama in Birmingham. The device, created by Aeris, offers a less invasive way to shrink lung volume by delivering foam to diseased parts of the lungs. (11/5) LinkedInFacebookTwitterEmail this Story
  Industry Service Providers 
  Government & Regulatory 
  • Paragonix seeks 510(k) clearance for cardiac transport device
    Paragonix Technologies has filed an application with the FDA seeking 510(k) clearance for the Sherpa Pak Cardiac Transport System. The disposable device, which is used to store donor hearts in transit, releases oxygenated blood to organs and is designed to extend the preservation time for donor hearts from the current four hours to 12 hours. Mass High Tech (Boston) (11/6) LinkedInFacebookTwitterEmail this Story
AdvaMed News 
  • Physician Payment Sunshine Act Seminar for Medical Devices
    Wednesday, Nov. 14
    AdvaMed headquarters, Washington, D.C.
    Discuss the implementation issues and challenges of interacting with customers during the statutory review period. Achieve a better understanding of identifying and tracking payments to covered recipients. Obtain step-by-step guidance on classifying payment types such as education expenses, consultant fees, and meals and travel. Learn more about disclosure reporting. Network with industry experts and leaders who will be available to discuss your tracking systems, reporting methods and review processes, and who will provide guidance on potential solutions to your compliance challenges. Register for the seminar. 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
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Position TitleCompany NameLocation
Director of Quality CEA Medical Manufacturing Colorado Springs, CO
Compliance Manager, Global DistributionCooperVision, Inc.Rochester, NY or Pleasanton, CA, NY
Associate Director, Regulatory AffairsAbbott LaboratoriesSanta Clara, CA
Senior Marketing Communications Manager - Cardiac Surgery Systems - 001558Edwards LifesciencesIrvine, CA
Packaging Engineer/Project LeaderEndologix, Inc.Irvine, CA
Sr. Manager R & D, Systems Integration EngineeringAbbott LaboratoriesSanta Ana, CA
Regulatory Affairs Associate DirectorAbbott LaboratoriesSanta Clara, CA
Physician Training Program ManagerEndologix, Inc.Irvine, CA
Director Clinical Research - CapnographyCovidienBoulder, CO
Field Service Engineer IRIS International, IncSacramento, CA
Quality EngineerIRIS International, IncChatsworth, CA
Medical and Clinical Laboratory TechnologistIRIS International, IncChatsworth, CA
Senior Mechanical EngineerIRIS International, IncChatsworth, CA
Clinical & Customer Care SpecialistIRIS International, IncLos Angeles, CA
Developmental Cell Biologist/BiochemistIRIS International, IncCarlsbad, CA
Principal Systems Engineer IRIS International, IncChatsworth, CA
Field Service Engineer IRIS International, IncProvidence, RI
Director Professional Medical Education CovidienBoulder, CO
Click here to view more job listings.

Success is often just an idea away."
--Frank Tyger,
American cartoonist, columnist and humorist

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