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December 5, 2012News 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 
 
  • Va. medtech service provider consolidates N.C. operations
    Aptiv Solutions has set up a new facility in North Carolina in an effort to merge its operations in Raleigh and its Trio Clinical Resourcing business in Morrisville into one location. The Reston, Va.-based company provides services to companies in the medical device and biopharmaceutical sectors. MassDevice.com (Boston) (12/2) LinkedInFacebookTwitterEmail this Story
  • Incubator group adds 2 early-stage life sciences companies
    North Shore Innoventures has added three early-stage firms, including Cellanyx Diagnostics and Sextant Therapeutics, to its incubator program. Cellanyx's specialty is in vitro cell and tissue culturing technologies used for in vitro diagnostics, while Sextant focuses on tests used to identify the most effective chemotherapy for a specific type of cancer. Mass High Tech (Boston) (12/4) LinkedInFacebookTwitterEmail this Story
From Baby Boomer to Millennial
Michael Parrish Dudell, bestselling author and one of nation's leading Millennial voices, explains why now, more than ever, is the time for businesses to anticipate the rapidly evolving expectations of the new workforce or face the very real threat of irrelevance. Read the brief to get the facts on the huge impact Millennials will and are making in the workplace.
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  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.
Top 5 Concerns Amazon Business Helps You Address
Amazon Business gives health care vendors and suppliers the ability to deliver the experience customers want without having to make a large investment in digital infrastructure. In this SmartFocus report we explore five critical business challenges currently facing companies in the healthcare space and what Amazon Business is doing to help effectively address them. Read it now >>
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  Science & Health 
  • Cognoptix develops test for early detection of Alzheimer's
    Cognoptix has created an eye-scanning assay that can be used to identify a patient's risk for Alzheimer's disease early and in a noninvasive manner. The device, comprised of ophthalmic ointment and a laser-based reading system, was developed using technology licensed from the University of California in San Diego. Mass High Tech (Boston) (12/4) LinkedInFacebookTwitterEmail this Story
  Emerging Technologies 
  Government & Regulatory 
  • 2.3% device tax is a "tax within a tax," medtech exec says
    Dynatronics CEO Kelvyn Cullimore says that the 2.3% device tax that will be levied on medtech companies starting next month constitutes "a tax within a tax" and could necessitate that companies take drastic steps, including layoffs, price increases or shipping manufacturing jobs overseas. “In this sector, the profit threshold is not usually crossed until a company achieves $25-50M revenue,” Cullimore said, adding that companies routinely incur an operating loss in the R&D phase as they innovate new products. The medical device tax, he said, would require companies to add to their working capital needs. Forbes (12/1) LinkedInFacebookTwitterEmail this Story
  • CMS urged to release final rule on sunshine law this month
    Medtronic and the Pew Charitable Trusts have asked CMS to issue a final rule this month governing the sunshine law, which mandates that medtech firms and other health care companies report payments made to hospitals and doctors. "Many companies have already invested significant resources in preparing to comply with the sunshine provision," representatives wrote in a letter to CMS Acting Administrator Marilyn Tavenner. MassDevice.com (Boston) (12/3), Reuters (11/28) 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
  • Follow AdvaMed on Google+
    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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Position TitleCompany NameLocation
Payer Relations DirectorSonitus Medical IncSan Mateo, CA
Clinical Project ManagerEndologix, Inc.Irvine, CA
Physician Training Program ManagerEndologix, Inc.Irvine, 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.

  SmartQuote 
The forceps of our minds are clumsy things and crush the truth a little in the course of taking hold of it."
--H.G. Wells,
British author


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