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March 13, 2013News for medical technology professionals

  Top Story 
 
CAPA Whitepaper and Case Study
CAPA violations are still the number one cited 483 observation during inspections. Learn more from this whitepaper and case study.
  Business & Market Trends 
  • J&J unit wraps up Flexible Stenting Solutions acquisition
    Cordis, a Johnson & Johnson unit, has finalized its purchase of Flexible Stenting Solutions for undisclosed terms. The deal is expected to allow Cordis to extend the therapeutic uses of its S.M.A.R.T. vascular stent into venous and below-the-knee interventions, among other benefits. RTT News (3/12) LinkedInFacebookTwitterEmail this Story
  • Covidien CEO: How to make crucial decisions
      
    Businesses must know their key challenges, and for hospitals, those are blood loss, infection and re-admission, Covidien CEO Jose Almeida says in this video interview. "If you think about how hospitals will be paid in the future, if you as a device company can address those three things with your products, at least one of them...you’re better off," he said. "Our customers are under siege, and they have to do a lot of things in the future different than they are doing today." The Wall Street Journal (3/12) LinkedInFacebookTwitterEmail this Story

  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.
  Science & Health 
  • Pivotal phase of St. Jude's stroke device trial begins
    St. Jude Medical has begun patient enrollment in the pivotal phase of a clinical study comparing its Amplatzer Cardiac Plug with long-term blood thinner therapy. The trial, which will involve up to 3,000 patients in Canada and the U.S., will test the safety and efficacy of the device in keeping blood clots from moving out of the heart's left atrial appendage. MassDevice.com (Boston) (3/12) LinkedInFacebookTwitterEmail this Story
  Emerging Technologies 
  • Surgionix to launch orthopedic device at Chicago event
    New Zealand-based Surgionix plans to release its SLICK drill bit system at an orthopedic surgeons meeting in Chicago next week. The technology incorporates a depth gauge into a conventional bone bit to enable orthopedists to combine two tasks and reduce procedure time. MedGadget.com (3/11) LinkedInFacebookTwitterEmail this Story
 
  • IPhone-based ECG device gets FDA OK for nonprescription use
    The FDA has granted Cardiac Designs over-the-counter clearance for its ECG Check system. The device, designed to work with the iPhone 4S, records and transmits ECG readings to the mobile phone using Bluetooth connectivity. The information can then be sent to the ECG Check web center for evaluation by health care professionals. MobiHealthNews.com (3/12) LinkedInFacebookTwitterEmail this Story
  Government & Regulatory 
AdvaMed News 
  • Navigating the SEC's New Conflict Minerals Disclosure Requirements
    Thursday, April 11
    Webinar, 1:00 p.m. - 2:00 p.m. EST
    The SEC recently approved the much-debated conflict minerals due-diligence disclosure rules that were originally developed in the Dodd-Frank Wall Street Reform and Consumer Protection Act. The rule requires public companies to disclose the use of any conflict minerals that “are necessary to the functionality or production of a product manufactured” or “contracted to be manufactured” by that company. While not banning the use of conflict minerals, it does require companies to assess their supply chains and publically disclose their use of the minerals. When your company is producing either components or finished medical devices for customers, you will need to understand the nuances of your supply-chain position in relation to the SEC's rule. Learn more about SEC’s rule in this comprehensive webinar. Visit MTLI online for more information. LinkedInFacebookTwitterEmail this Story
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Position TitleCompany NameLocation
Sales Area Manager/Sales Rep of Neurovascular Intervention ProductsAsahi Intecc USA, Inc.Any location in US, CA
Project Manager, Regulatory Affairs - Transfusion Medicine Johnson & JohnsonRaritan, NJ
Associate CounselACell, Inc.Columbia, MD
Compliance Consultant 2DJO GlobalVista, CA
Accreditation ManagerAmerican Association of Tissue BanksMcLean, VA
REGULATORY AFFAIRS SPECIALISTMasimo CorporationIrvine, CA
Director, Health Care ComplianceRTI BiologicsAlachua, FL
Manager, HCL Regulatory & Quality ComplianceOwens & MinorLouisville, KY
DIR OPERATIONS, Milpitas Site - 130000007RAbbott San Jose, CA
Biostatistician - Post Market Surveillance Johnson & JohnsonRaynham, MA
Click here to view more job listings.

  SmartQuote 
Humor is an affirmation of dignity, a declaration of man's superiority to all that befalls him."
--Romain Gary,
French diplomat, novelist, film director and aviator


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