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December 31, 2012News 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 
  • O'Brien Medical advances diabetic neuropathy detection device
    O'Brien Medical has created a prototype of a device, called NeuroCheck, which is inspired by the tuning fork to detect diabetic neuropathy in the feet early. The digital device, which uses vibrations to detect the condition, already has been tested in a small clinical study and will soon be developed into a model that could be mass-produced, said company founder Todd O'Brien, who plans to pursue 510(k) clearance this winter. (12/28) LinkedInFacebookTwitterEmail this Story
  International Developments 
  • Cardica distributes cutting/stapling device in Europe
    DACH Medical, which distributes medical supplies for Cardica in several European countries, is receiving the first shipment of the MicroCutter XCHANGE 30 device, which will go to hospitals in Switzerland and Austria. Cardica plans to launch wider sales throughout Europe for the device, which is used for cutting and stapling during laparoscopic and thoracoscopic surgeries, and also plans to apply for regulatory clearance in the U.S. Medical Devices Business Review (U.K.) (12/27) LinkedInFacebookTwitterEmail this Story
  Science & Health 
  • Foundation offers $9M for studies on gut disease biomarkers
    The Mayo Clinic and six other groups received $9 million from the Bill and Melinda Gates Foundation to finance efforts to identify biomarkers tied to gut function and disease. The Mayo Clinic will use its share of the funds to create a biomarker-based assay to detect an intestinal condition called environmental enteropathy, which inflicts 146 million children in developing countries. GenomeWeb Daily News (free registration) (12/27) LinkedInFacebookTwitterEmail this Story
  Emerging Technologies 
  • Amputee to climb Mt. Washington with prosthetic leg
    Amputee Keith Zeier will use a custom-made prosthesis to climb New Hampshire’s Mt. Washington in January. The trek is intended to raise money and awareness for the Special Operations Warrior Foundation, which aids families of soldiers injured or killed in combat. Zeier lost his leg from injuries he received as an elite Marine in Iraq. New York Post (12/24) LinkedInFacebookTwitterEmail this Story
  Hot Topics 

Top five news stories selected by AdvaMed SmartBrief readers in the past week.

  • Results based on number of times each story was clicked by readers.
  Government & Regulatory 
  • Coaxia's NeuroFlo catheter undergoes FDA panel review
    An FDA panel recently met to consider CoAxia's de novo application for use of its NeuroFlo catheter within 14 hours after symptoms begin to show in ischemic stroke patients who aren't fit to receive thrombectomy or tissue plasminogen activator. The device, which already has 510(k) clearance, is used to control or halt the flow of blood in peripheral vessels. Medscape (free registration) (12/28) LinkedInFacebookTwitterEmail this Story
AdvaMed News 
  • Premarket Approval (PMA) Submissions Workshop
    Thursday, Feb. 28 – Friday, March 1
    Sheraton Crystal City, Arlington, Va.
    Completing the MTLI set of interactive submissions workshops, senior industry experts and members of the CDRH device evaluation and bioresearch monitoring staffs lead participants through the strategic considerations and practical steps of filing a PMA, illustrated with real-world case studies. Topics include strategy development and evidence requirements, productive meetings with the FDA, the mechanics of submission development, advisory panels, inspectional activity, conditions of approval studies, and the care and feeding of approved PMAs. 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
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IP Litigation Counsel III - 001980Edwards LifesciencesIrvine, CA
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  Editor's Note 
  • SmartBrief will not publish Tuesday
    In observance of New Year's Day, SmartBrief will not publish Tuesday. Publication will resume Wednesday. Enjoy the holiday! LinkedInFacebookTwitterEmail this Story
Never tell your resolution beforehand, or it's twice as onerous a duty."
--John Selden,
English jurist and scholar

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