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January 2, 2013News for medical technology professionals

  Top Story 
7 keys: Put real-world evidence into action
Life sciences organizations need to know how their therapies work in the real world once clinical trials end. And these seven key components to standardizing real-world data and analytics platforms are how they get started. Read the paper, Institutionalizing Real World Evidence.
  Business & Market Trends 
  • 3 things medical device firms should consider this year
    Although the current state of the medical device industry poses difficulties, the industry should start the new year looking past existing challenges, including those tied to the medical device tax, and focusing on long-term opportunities such as expanding into emerging markets, according to this article. The industry should also consider changing its business model and engaging patients more, this article notes. (Boston) (12/31) LinkedInFacebookTwitterEmail this Story
  • Access Genetics buys Quest Diagnostics unit
    Access Genetics has acquired almost all of the assets of OralDNA Labs, a Tennessee-based unit of Quest Diagnostics that supplies testing services based on saliva samples. The deal, whose terms were not disclosed, is part of Quest's strategy to concentrate on its core business related to diagnostic data services for hospitals and doctors. GenomeWeb Daily News (free registration) (12/31) LinkedInFacebookTwitterEmail this Story
  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.
  • Scottish firm mulls sale of polymer plant in Minn.
    AorTech is considering selling its polymer manufacturing plant in Rogers, Minn., which was established in 2011. St. Jude Medical, which employs the Scottish company's Elast-Eon technology to coat cardiac defibrillator leads, is said to be a possible buyer. (12/28) LinkedInFacebookTwitterEmail this Story
  Science & Health 
  • Technology from Biosensia allows point-of-care disease diagnosis
    Biosensia is working on technology, called the RapiPlex platform, which is intended to ease the way clinicians diagnose various medical conditions at the point of care. The company, which is based in Dublin, Ireland, is seeking initial CE mark approval for the system to be used in running a myoglobin test, after which it will file for 510(k) clearance with the FDA. Silicon Republic (Ireland) (12/31) LinkedInFacebookTwitterEmail this Story
  Emerging Technologies 
  • Virtual surgical planning tools from Medical Modeling get FDA OK
    The FDA has cleared Medical Modeling to market its VSP systems for use in maxillofacial and oral surgery. The portfolio includes VSP Orthognathics, which allows CAD/CAM surgical splints and virtual surgical planning to be applied to the orthognathic procedure site, and VSP Reconstruction, which involves the use of vascularized grafts to repair the mandible or maxilla. (free registration) (12/31) LinkedInFacebookTwitterEmail this Story
  Industry Service Providers 
  • BC Technical to acquire imaging services company
    BC Technical, which sells and services molecular imaging equipment and parts, is acquiring Genesis Medical Imaging, a provider of PET/CT, MRI and CT services. Genesis Medical President Robert Dakessian said the move is "a great decision for Genesis." (12/29) LinkedInFacebookTwitterEmail this Story
  Government & Regulatory 
  • Proposed device ID rule may result in changes to packaging lines
    The FDA's proposal to set up a unique device identifier system for medical technologies will compel firms to modify their packaging lines, which could be costly, according to this article. The FDA Safety and Innovation Act mandates that a final rule on the proposal be issued in the middle of May, not the middle of June as previously thought, but the agency "doesn't seem to be confident of meeting either possible deadline," said AdvaMed's Vice President of Technology and Regulatory Affairs Jeffrey Secunda. Packaging World online (12/31) LinkedInFacebookTwitterEmail this Story
  • FDA labels Zimmer recall as Class I
    Medical device developer Zimmer Holdings has been given Class I status from the FDA for a global recall of its PEEK Ardis Inserter instruments over concerns that the devices could lead to problems during surgery, including severe bleeding. The December recall came on the heels of reports that the inserters may put too much pressure on the Ardis Interbody Spacers. The recall covers specific lots distributed from June 2008 to December 2012. (Boston) (1/1) LinkedInFacebookTwitterEmail this Story
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Position TitleCompany NameLocation
IP Litigation Counsel - 001980Edwards LifesciencesIrvine, CA
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Physician Training Program ManagerEndologix, Inc.Irvine, CA
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Birds sing after a storm; why shouldn't people feel as free to delight in whatever remains to them."
--Rose Kennedy,
American philanthropist

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