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February 20, 2013News for medical technology professionals

  Top Story 
 
The odds of receiving an Inspectional Observation (483) or a subsequent Warning Letter have been sharply on the rise, and the seriousness of each remains high. How do you respond?
  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.
  • EU OKs Dune's next-gen breast cancer tissue assessment device
    Dune Medical Devices has obtained approval in Europe to market a next-generation version of its MarginProbe System console, a device used for intra-operative tissue evaluation during early-stage breast cancer procedures. The MarginProbe System Type 1.2 improves on the original model with a more compact size, better aesthetics and enhanced overall design. Boston Herald (2/19) LinkedInFacebookTwitterEmail this Story
  Science & Health 
  • Neuroprosthetic therapies may enable spinal injury patients to walk
    Swiss scientists are developing neuroprosthetic technologies designed to restore voluntary locomotion control to patients with severe spinal cord injuries. Grégoire Courtine, of the École Polytechnique Fédérale de Lausanne, expects to begin clinical human trials within the next two years. He detailed his study, which used a robotic harness and electrochemical stimulation to restore movement in paralyzed rats, and described what's ahead at a recent scientific meeting in Boston. Innovations-Report.com (2/18) LinkedInFacebookTwitterEmail this Story
  Emerging Technologies 
  • Breakthrough prosthetic hand will have the ability to feel
    Later this year, an amputee in Rome will be fitted with the first prosthetic hand to offer the sensation of touch. Doctors hope that by connecting the hand’s wiring directly to the patient’s median and ulnar nerves in the arm, he will be able to move the device by thinking as well as receiving sensory signals from the fingertips, the palm and the wrist. “It will be the first prosthetic that will provide real-time sensory feedback for grasping,” said Dr. Silvestro Micera of the Ecole Polytechnique Federale de Lausanne in Switzerland. The Independent (London) (2/17) LinkedInFacebookTwitterEmail this Story
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  Industry Service Providers 
  Government & Regulatory 
  • FDA issues draft guidance on third-party device review program
    The FDA has released draft guidance on changes to its program to accredit third-party entities to review certain medical device applications. The draft guidance, based on the International Medical Device Regulators Forum's proposal to create a unified program for medtech auditors, covers compliance with the FDA Safety and Innovation Act, including a provision regarding third-party firm accreditation. Firms must seek reaccreditation every three years. Clinica (subscription required) (2/19) LinkedInFacebookTwitterEmail this Story
AdvaMed News 
  • Join the AdvaMed-MTLI LinkedIn group!
    Build close relationships with member companies, both small and large, and receive an intimate understanding of the key issues affecting innovation, access and the bottom line. Interact in discussions that leverage the leadership and expertise of the medical technology industry. This social group is full of key stakeholders, influencers and industry thought leaders as well as regulatory and policy experts from the FDA and CMS. Aside from practical learning opportunities, this LinkedIn group provides the premier opportunity to network with key players from virtually every aspect of the industry. Link to the AdvaMed MTLI LinkedIn group page. LinkedInFacebookTwitterEmail this Story
 
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Position TitleCompany NameLocation
Neurovascular Intervention Marketing ManagerAsahi InteccSanta Ana, CA
Manager, HCL Regulatory & Quality ComplianceOwens & MinorLouisville, KY
Clinical Operations ManagerCochlear LimitedSydney, Australia
Director of ManufacturingMBio Diagnostics, Inc.Boulder, CO
Director of Global Infrastructure - 002196Edwards LifesciencesIrvine, CA
DIR OPERATIONS, Milpitas Site - 130000007RAbbott San Jose, CA
Regional Service Manager PhilipsHartford, CT
Engineer, Process DevelopmentArthroCare CorporationIrvine, CA
Biostatistician - Post Market Surveillance Johnson & JohnsonRaynham, MA
Sr. QA Manager - Quality Systems (Santa Barbara)AllerganSanta Barbara, CA
Legal Counsel IIMedtronic, Inc.Minneapolis, MN or Washington, DC, United States
Click here to view more job listings.

  SmartQuote 
We must travel in the direction of our fear."
--John Berryman,
American poet and scholar


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