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February 12, 2013News for medical technology professionals

  Top Story 
 
Covidien STAR Results Promising Despite IMS III Study Outcomes
Covidien (Dublin, Ireland) reported the release of the results from the Solitaire FR Thrombectomy for Acute Revascularization (STAR) study. The two-year study evaluated the safety and efficacy of the Solitaire FR revascularization device in the treatment of acute ischemic stroke. Find out the details.

  Business & Market Trends 
  • Pa. maker of tissue graft derived from placenta obtains $2.23M
    AFcell Medical has obtained $2.23 million of a targeted $10 million round, which it will use to establish its sales and marketing team. The Pennsylvania-based startup is the maker of AmnioClear, a tissue graft derived from the placenta of living human donors that could speed recovery for tendon surgery or wound repair patients. MedCityNews.com (2/11) LinkedInFacebookTwitterEmail this Story
  • Luoxis launches to market oxidation reduction Dx tool
    Luoxis Diagnostics, an Ampio Pharmaceuticals unit, has launched operations to market the Oxidation Reduction Potential diagnostics platform. The technology is designed for use in developing disposable testing strips and a point-of-care reader for various conditions. RTT News (2/11) LinkedInFacebookTwitterEmail this Story
  International Developments 
  • Japan loosens stability testing requirements for devices
    Japan will no longer require medtech companies to include stability testing data in order to get approval for devices after a Regulatory Task Force agreed the requirements could be eliminated in most cases. The task force is comprised of the country's Ministry of Health, Labour and Welfare, as well as medical device industry representatives. The move is meant to alleviate the delay in medical device approval in Japan, but certain devices still require the data, including those that contain certain raw materials, biological products and radioactive material. Clinica (subscription required) (2/11) LinkedInFacebookTwitterEmail this Story
  Science & Health 
  • Holaira gets $10M boost to develop lung denervation system
    Holaira has secured $10 million in a Series C funding round, which it aims to use to develop a lung denervation device for treating chronic obstructive pulmonary disease. The company, previously called Innovative Pulmonary Solutions, also has relocated its headquarters to Minneapolis as it prepares for the next phase of product development and clinical studies. MassDevice.com (Boston) (2/11) LinkedInFacebookTwitterEmail this Story
  Emerging Technologies 
  Industry Service Providers 
  • Ore. hospital buys orthopedic DR device from EOS
    EOS Imaging has sold a unit of its orthopedic digital radiography system to Shriners Hospitals for Children-Portland in Oregon. The technology allows patients to be scanned in a sitting or standing position and uses a radiation dose that is lower by up to nine times than traditional radiographs, the company said. AuntMinnie.com (free registration) (2/11) LinkedInFacebookTwitterEmail this Story
  Government & Regulatory 
AdvaMed News 
  • Medical Device Reimbursement Workshop
    Tuesday, Feb. 26 – Wednesday, Feb. 27
    Sheraton Crystal City, Arlington, Va.
    Learn from medical device reimbursement experts what new legislative and regulatory changes apply to the area of reimbursement; the key reimbursement issues for medical technology; how Medicare coverage is determined at the national and local levels; the role of MEDCAC; why technology assessments are important; how clinical trial results impact payers; what you need to do to keep up on new reimbursement developments relevant to your products; how to maintain a nimble, dynamic, effective, ongoing reimbursement program; what to do when reimbursement is denied; drill-down coding systems; differences in inpatient and outpatient payment systems; physician fee schedules and product design; how to negotiate CMS coverage; how to plan for the new health care reform landscape deal with comparative effectiveness; and how to manage international reimbursement. 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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Position TitleCompany NameLocation
Neurovascular Intervention Marketing ManagerAsahi InteccSanta Ana, CA
Director of ManufacturingMBio Diagnostics, Inc.Boulder, CO
Director of Global Infrastructure - 002196Edwards LifesciencesIrvine, CA
Engineer, Process DevelopmentArthroCare CorporationIrvine, CA
Legal Counsel IIMedtronic, Inc.Minneapolis, MN or Washington, DC, United States
Regional Service Manager PhilipsHartford, CT
Sr. QA Manager - Quality Systems (Santa Barbara)AllerganSanta Barbara, CA
Product Support Specialist IVArthroCare CorporationAustin, TX
Director of Clinical AffairsEndologixIrvine, CA
Sr. Clinical Research AssociateEndologix, Inc.Irvine, CA
Click here to view more job listings.

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We spend our time searching for security and hate it when we get it."
--John Steinbeck,
American author


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