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November 30, 2012News for medical technology professionals

  Top Story 
  • Edwards' mitral heart valve clears regulatory hurdle in China
    China's State Food and Drug Administration granted approval for Edwards Lifesciences to market its Carpentier-Edwards Perimount device, which offers a treatment option for patients in need of mitral heart valve replacement. The mitral valve, made from bovine pericardial tissue, already has been cleared in the U.S. and also has CE Mark approval in Europe. (Boston) (11/29) LinkedInFacebookTwitterEmail this Story
  Business & Market Trends 
  • Mitral heart valve maker CardiAQ obtains $37.3 million
    California-based CardiAQ Valve Technologies secured $37.3 million in an equity financing round headed by OrbiMed Advisors. The money will be used to finance studies intended to support the company's CE mark approval application for its implantable device used in mitral valve replacement. (Boston) (11/29) LinkedInFacebookTwitterEmail this Story
  • Tangent secures $8.6 million to bring IV catheter to market
    Tangent Medical Technologies, a spinoff of the University of Michigan's Medical Innovation Center, obtained $8.6 million from nine backers in a round of equity financing. The money is expected to be used to market the company's NovaCath system, an FDA-cleared intravenous catheter designed to promote patient comfort, avoid blood spatters and protect patients from pathogen exposure. (11/29) LinkedInFacebookTwitterEmail this Story
  International Developments 
  • European Commission gets new health leader
    The European Commission has confirmed Tonio Borg, Malta's deputy prime minister and foreign minister, as its new health commissioner, replacing John Dalli. Borg will oversee the commission's regulatory programs involving drugs, medical devices and other industries through Oct. 31, 2014. Clinica (subscription required) (11/29) LinkedInFacebookTwitterEmail this Story
  • Guidance aims to relax Class A device licensing rules in Singapore
    The Health Sciences Authority in Singapore released draft guidance on new standards for licensing Class A medical devices. The new rules, which are part of a revised quality management program set to go into effect in January, will no longer require wholesale dealers and importers of Class A devices to receive third-party audits or certification when licensing their products. Clinica (subscription required) (11/28) LinkedInFacebookTwitterEmail this Story
  Science & Health 
  • Exoskeleton is designed to increase mobility for paraplegics
    Therapists working with the prototype of a new robotic exoskeleton say it is light, easy to use and more affordable than other, similar devices. Developed at the Vanderbilt labs of Michael Goldfarb, the exoskeleton has built-in functional electrical stimulation and can navigate ramps, stairs and grass. “It takes natural signals and creates natural motions,” said Ryan Farris, co-designer of the exoskeleton, which manufacturer Parker Hannifin anticipates will be available in the U.S. by 2014. FastCoExist (11/28) LinkedInFacebookTwitterEmail this Story
  Emerging Technologies 
  • Siemens introduces mobile C-arm with more power
    Siemens introduced Cios Alpha, a mobile C-arm that features beam-shaping collimators that yield uncropped square images even when the X-ray tube is moved around. The device also offers a 25-kilowatt power output to accommodate bariatric patients and built-in cooling technology to prevent overheating during long procedures and allow fast patient turnaround. (11/29) LinkedInFacebookTwitterEmail this Story
  Industry Service Providers 
  Government & Regulatory 

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AdvaMed News 
  • Medical Device Reimbursement Workshop
    Tuesday, Feb. 26 – Wednesday, Feb. 27
    Sheraton Crystal City, Arlington, Va.
    AdvaMed MTLI’s workshop for medical technology reimbursement professionals will provide the road map to successfully navigate the many potential pitfalls. After an overview of reimbursement issues, the workshop will drill down to coding systems, technology assessments and differences in inpatient and outpatient payment systems. Hear from experts on how to negotiate CMS coverage. Learn how to plan for the new health care reform landscape, deal with comparative effectiveness and manage international reimbursement. Visit MTLI online for more information. LinkedInFacebookTwitterEmail this Story
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Position TitleCompany NameLocation
Director of Quality CEA Medical Manufacturing Colorado Springs, CO
Payer Relations DirectorSonitus Medical IncSan Mateo, CA
Clinical DirectorStrykerFreemont, CA
Clinical Education Manager, Vascular TherapiesCovidienMansfield, MA
Manager, Grassroots and Member Engagement, Government Affairs AdvaMedWashington, DC
Associate Vice President, Global Strategy and Analysis (Asian Region) AdvaMedWashington, DC
Manager, Regulatory Affairs Sequenom, Inc.San Diego, CA
Senior/Principal Mechanical EngineerChannel MedsystemsSan Francisco, CA
Director, Valve Testing - Transcatheter Heart Valve - 001221Edwards LifesciencesIrvine, CA
Senior Director, QualityAmerican Medical SystemsMinneapolis, MN
Strategic Sourcing Manager Alpha Source, Inc.Milwaukee, WI
Click here to view more job listings.

The robbed that smiles, steals something from the thief."
--William Shakespeare,
British playwright

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