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November 5, 2012News for medical technology professionals

  Top Story 
  Business & Market Trends 
  • Carestream announces Genesis Digital acquisition
    Carestream Health has agreed to buy Genesis Digital Imaging, which develops imaging software and supplies diagnostic imaging devices, for undisclosed terms. The deal will allow Carestream to add Genesis to its medical division and help broaden its footprint in the U.S. "value-tier" segment. (11/2), (11/2) LinkedInFacebookTwitterEmail this Story
  • Former HemoSphere exec takes the helm of CardioInsight
    Patrick Wethington has been tapped to serve as president and CEO of CardioInsight Technologies, which specializes in noninvasive electrocardiographic mapping systems. Wethington, who most recently worked at HemoSphere as president and CEO, replaces Steve Arless, who stepped down in April. (Boston) (11/2) LinkedInFacebookTwitterEmail this Story
  International Developments 
  • Group IDs 10 areas for harmonizing medtech regulations in Asia
    A list has been issued by the Asian Harmonization Working Party of 10 areas it views as having the "most potential for success" in promoting medtech regulatory convergence among its 23 member countries, starting with using a common definition for what is deemed a "medical device." The list is part of the group's proposed "Strategic Framework Towards 2020." Clinica (subscription required) (11/1) LinkedInFacebookTwitterEmail this Story
  Science & Health 
  • Direct Flow reports positive trial results for aortic valve
    More than 95% of patients in a study of Direct Flow Medical's Transcatheter Aortic Valve System saw minimal or mild aortic regurgitation, while no patients had vascular complications. The device, which consists of bovine pericardium leaflets, a polymer frame and two inflatable rings, can be repositioned easily for improved fit or extracted if complications arise. (11/2) LinkedInFacebookTwitterEmail this Story
  Emerging Technologies 
  • Accuray scores FDA clearance for next-gen CyberKnife device
    The FDA has cleared Accuray to market the CyberKnife M6 Series, a next-generation line of the company's radiosurgery system. The company also secured 510(k) clearance for the InCise Multileaf Collimator, which is used to tailor an X-ray beam to the dimensions of a tumor, and is designed to work with the new FM and FIM CyberKnife models. (11/2) LinkedInFacebookTwitterEmail this Story

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

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  Industry Service Providers 
  Government & Regulatory 
  • CMS seeks comments on new molecular Dx reimbursement scheme
    The new codes for molecular diagnostic tests released by the American Medical Association will be reimbursed under the CMS' clinical laboratory fee schedule starting Jan. 1, according to a final ruling, which is up for comment for 60 days. That portion pertaining to certain tests that need physician interpretation, however, will be covered under the physician fee schedule. GenomeWeb Daily News (free registration) (11/2) LinkedInFacebookTwitterEmail this Story
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    Learn how to communicate your value without overstepping legal and regulatory boundaries. FDA staff, medical technology company leaders, legal experts and public affairs professionals will clarify the boundaries and the best practices for navigating these challenges. Our dialogue will include FDA and FTC regulations, risk management, the limits on label and advertising content, off-label use information, social media opportunities and challenges, promotion to providers and direct-to-consumer communications. Register for the workshop. LinkedInFacebookTwitterEmail this Story
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Whoever is winning at the moment will always seem to be invincible."
--George Orwell,
British novelist and journalist

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