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December 10, 2012News for medical technology professionals

  Top Story 
  • Devicor gets FDA OK for biopsy device
    The FDA has granted Devicor Medical Products approval for Mammotome revolve, which is used to obtain breast tissue biopsies. The device comes with the proprietary DualVac vacuum system to allow clinicians to obtain larger, contiguous breast tissue specimens, among other features. Medscape (free registration) (12/7) LinkedInFacebookTwitterEmail this 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 
  • Pa. maker of lymphedema device pulls in $3 million
    A Series B financing round has brought in $3 million for Wright Therapy Products. The Oakdale, Pa.-based company will use the money to boost sales of its compression therapy system and compliance program for patients with lymphedema, as well as market over the next 18 to 24 months two to three of its devices under development. (12/7) LinkedInFacebookTwitterEmail this Story
  International Developments 
  Science & Health 
  • Canadian patient becomes first to receive Sorin's heart implant
    Sorin has announced its Paradym RF system has been implanted for the first time in a patient at the Montreal Heart Institute in Canada. The implantable heart device incorporates the Smartview remote monitoring technology, which allows clinicians to receive crucial patient information from the system wirelessly and evaluate the data online. (Boston) (12/7) LinkedInFacebookTwitterEmail this Story
  Emerging Technologies 
  • CoreLab unveils imaging system for Alzheimer's diagnosis
    CoreLab Partners has introduced an imaging service designed for use of an independent central image review system for the diagnosis of early Alzheimer's disease. Michael Woehler, CoreLab's president and CEO, said the company plans to establish a team of health care providers equipped with the proper tools for improved evaluation of images from various advanced modalities, including PET and SPECT. (free registration) (12/6) LinkedInFacebookTwitterEmail this Story
  • Breast analysis software from Siemens makes debut
    Siemens Healthcare has announced the launch of its syngo.Ultrasound Breast Analysis tool, which allows offline evaluation of medical images, clips and volumes generated by the firm's Acuson S2000 ultrasound device and Acuson S2000 breast scanner. The software includes image reporting and processing tools for improved imaging quality and workflows. (free registration) (12/7) 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.
  Industry Service Providers 
  • Mich. cancer facility adopts GE's breast imaging device
    Barbara Ann Karmanos Cancer Institute in Detroit has deployed GE Healthcare's Discovery NM750b system, which is used for breast cancer screening in women with dense breast and others who are deemed high risk for the disease. This marks the third U.S. clinical site to provide the system, which was introduced by GE worldwide last year. (free registration) (12/7) LinkedInFacebookTwitterEmail this Story
  Government & Regulatory 
  • N.C. senator seeks "fiscally responsible" way to repeal device tax
    Sen. Kay Hagan, D-N.C., is in talks with state business leaders to find viable ways to compensate for the estimated $30 billion in revenue from the impending 2.3% medical device tax, which she hopes to get repealed. "My number one priority is getting North Carolina back to work, and I believe that increasing the number of these good-paying jobs will be essential to our state's economic security," she said. (Boston) (12/7) LinkedInFacebookTwitterEmail this Story
  • FDA panel sets review date for NeuroPace's epilepsy device
    An FDA panel will convene on Feb. 22 to evaluate NeuroPace's premarket approval application for the RNS System, an implantable device that uses neuromodulation to treat epilepsy patients. The meeting comes more than two years after the company submitted its PMA application for use of the device in minimizing seizures among patients who are at least 18 years old. (Boston) (12/7) 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
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Position TitleCompany NameLocation
Payer Relations DirectorSonitus Medical IncSan Mateo, CA
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Clinical DirectorStrykerFreemont, CA
Manager, Grassroots and Member Engagement, Government Affairs AdvaMedWashington, DC
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Senior Director, QualityAmerican Medical SystemsMinneapolis, MN
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Alas for those that never sing, But die with all their music in them."
--Oliver Wendell Holmes Sr.,
American physician, writer and poet

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