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Emergo Group can help you start selling your medical device in Brazil. ANVISA approvals, BGMP.
February 26, 2013News for medical technology professionals

  Top Story 
 
  • Biotronik wins FDA nod for single-lead, atrial-sensing ICD
    The FDA has granted Biotronik approval for its implantable cardioverter defibrillator that uses advanced sensors and the company's LinoxsmartS DX lead to allow doctors to monitor and detect atrial arrhythmias with just one lead. The device, called Lumax 740 DX System, is targeted for implantation in the U.S. starting late this month or early next month. Healio (2/25), CNET (2/25) LinkedInFacebookTwitterEmail this Story
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  Business & Market Trends 
  • Tornier names new CEO, reports sales and revenue growth
    Tornier has appointed David Mowry, its chief operating officer, as interim president and CEO, and Kevin O'Boyle as interim vice chairman. The Dutch orthopedic extremity device firm also announced 14% growth in revenue during its fourth fiscal quarter, with its recent purchase of OrthoHelix Surgical Designs driving up its sales. Clinica (subscription required) (2/25) LinkedInFacebookTwitterEmail this Story
  International Developments 
  • Medtech innovation soars in Brazil thanks to Conitec
    Brazil's national health system has doubled the average adoption rate of new health technology products and quadrupled the average technology appraisal rate since the establishment of its health technology assessment body, the National Commission for the Incorporation of New Technologies, or Conitec, in 2011. Conitec approved 29 medical products in 2012 and is evaluating 45 more, Brazil's health ministry said. Clinica (subscription required) (2/21) LinkedInFacebookTwitterEmail this Story
  Science & Health 
  Emerging Technologies 
  • Additional sizes of Medtronic's heart stent get FDA OK
    Medtronic has received approval from the FDA for the new 34-millimeter and 38-millimeter lengths of its Resolute Integrity stent. The new sizes are approved for use in treating coronary artery disease among diabetes patients, the same indication approved last year for core sizes of the drug-eluting stent. Healio (2/25), MassDevice.com (Boston) (2/25) LinkedInFacebookTwitterEmail this Story
  Industry Service Providers 
  • Medical plastics producers see applications in O&P
    Producers of thermoplastic elastomers welcomed recent guidance from the FDA that take into account usability engineering and human factors intended to improve medical device design. Producers have ideas to improve orthoses, prostheses and other devices, including using styrenic block copolymers to provide comfort and control in orthotic braces and using TPEs that offer grip properties and softness in prosthetic fingers. PlasticsToday.com (2/22) LinkedInFacebookTwitterEmail this Story
  Government & Regulatory 
AdvaMed News 
  • Investigational Device Exemption (IDE) Submissions Workshop
    Wednesday, Feb. 27
    Sheraton Crystal City, Arlington, Va.
    FDA staff leaders and industry experts at this interactive workshop will lead professionals through the regulatory and practical guidelines governing when an investigational device exemption is required; how to compile effective investigational device exemption applications; the eCopy Program for Medical Device Submissions; the rules governing clinical studies and human subject protection; Institutional Review Boards; types of pre- investigational device exemption meetings and communications; early/expanded access; foreign studies and export; and reimbursement for investigational devices. Visit MTLI online for more information. LinkedInFacebookTwitterEmail this Story
  • Premarket Approval (PMA) Submissions Workshop
    Thursday, Feb. 28 – Friday, March 1
    Sheraton Crystal City, Arlington, Va.
    Senior industry experts and members of the CDRH device evaluation and bioresearch monitoring staffs lead professionals through the strategic considerations and practical steps of filing a premarket approval, illustrated with real-world case studies. Topics include: the new acceptance and filing review guidance document; the eCopy Program for Medical Device Submissions; strategy development and evidence requirements; productive meetings with the FDA; the mechanics of premarket approval submission development; advisory panels; inspectional activity; and conditions of approval studies. Visit MTLI online for more information. LinkedInFacebookTwitterEmail this Story
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