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November 21, 2012News for medical technology professionals

  Top Story 
  • HeartWare gains FDA approval for cardiac pump
    HeartWare has obtained approval from the FDA for its left ventricular assist device, a cardiac pump designed to aid blood flow in end-stage heart failure patients awaiting transplants. The life-saving benefits of the system have been shown in a clinical study to outweigh the risks, according to the FDA. Reuters (11/20) LinkedInFacebookTwitterEmail this Story
Why Warmth Is Critical to Your Career
If people think you have low interpersonal warmth, "you have something like a 1-in-2000 chance to make the top quartile of effectiveness as a leader," according to Kellogg School of Management Professor Loran Nordgren. Read more.
  Business & Market Trends 
  International Developments 
Eucomed represents the medical technology industry in Europe. Our mission is to make modern, innovative and reliable medical technology available to more people. AdvaMed and Eucomed partner on issues of mutual interest.
  • Imagine's eye imaging device wins approval in Europe
    Imagine Eyes has earned CE mark approval in Europe for its rtx1 retinal camera, which the firm says is the first adaptive optics platform technology cleared for clinical use. The device allows cellular imaging of the retina to help doctors view structures that are often tied to vision-degrading conditions. (Boston) (11/19) LinkedInFacebookTwitterEmail this Story
  • Blood cell preparation device lands wider EU approval
    European regulators have granted Harvest Technologies broader CE mark approval for its SmartPReP 2 Bone Marrow Aspiration Concentration System. The device is now approved for processing concentrated blood cells at the point of care to be used in patients with end-stage critical limb ischemia. Mass High Tech (Boston) (11/19) LinkedInFacebookTwitterEmail this Story
  Science & Health 
  • Components combine to create advanced prostheses
    Using a new combination of the BiOM ankle/foot from iWalk and Ottobock’s X2 knee, retired Marine William Gadsby successfully hikes mountain trails and sand dunes. The BiOM has an active push-off when climbing stairs, and the X2 knee is able to anticipate and adjust for the user’s next step. Both use microprocessor systems to offer real-time adaptation to the environment. Pairing the two devices is a relatively new development, so more study is needed, say VA clinical care providers Dr. Joseph Webster and Dr. Joseph Miller. Stars and Stripes (11/17) LinkedInFacebookTwitterEmail this Story
  Emerging Technologies 
  • Hitachi unveils fexible ultrasound scanner
    Noblus, an ultrasound scanning device designed to work in various clinical settings, has been launched by Hitachi Aloka Medical. The scanner, which is comprised of a laptop PC and an optional cart, comes with real-time tissue elastography technology and other advanced capabilities. (free registration) (11/20) LinkedInFacebookTwitterEmail this Story
  Government & Regulatory 
  • FDA changes timeline for some devices under ID proposal
    The FDA is altering its proposed rule for a unique device identification system to comply with the Food and Drug Administration Safety and Innovation Act. A change in timeline primarily will affect Class II implantable, life-sustaining or life-supporting devices. (11/19) LinkedInFacebookTwitterEmail this Story
AdvaMed News 
  • 510(k) Submissions Workshop
    Monday, Feb. 25 - Tuesday, Feb. 26
    Sheraton Crystal City, Arlington, Va.
    This interactive workshop, taught by industry experts and key personnel from the CDRH 510(k) staff, leads participants step by step through the regulatory guidelines, practical steps and strategic considerations for determining a product’s regulatory route to market, identifying a predicate device, planning and assembling a 510(k) submission, interacting with the FDA during the review process, and dealing with post-clearance issues. Visit MTLI online for more information. LinkedInFacebookTwitterEmail this Story
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    Stay updated on industry news and educational opportunities -– receive an intimate understanding of the key issues affecting innovation, access and the bottom line. Network with industry experts and leaders. Our Google+ page is interactive and incorporates updates from key stakeholders, influencers and industry thought leaders as well as regulatory and policy experts from the FDA and CMS. Follow us on Google+. LinkedInFacebookTwitterEmail this Story
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Associate Director, Regulatory AffairsAbbott LaboratoriesSanta Clara, CA
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  Editor's Note 
  • SmartBrief will not publish Thursday and Friday
    In observance of Thanksgiving in the U.S., SmartBrief will not be published Thursday and Friday. Publication will resume Monday. Enjoy the holiday! LinkedInFacebookTwitterEmail this Story
If the only prayer you said in your whole life was 'thank you,' that would suffice."
--Meister Eckhart,
German theologian and philosopher

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