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May 7, 2012News for medical technology professionals

  Top Story 
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 >>
  Business & Market Trends 
  • Bioscience incubator slated to open next month in Ariz.
    BioInspire, an incubator that aims to invest in biomedical device startups, is scheduled to launch next month at a 6,800-square-foot facility in Peoria, Ariz. The incubator is a collaborative effort among the Peoria City Council, Plaza Companies and BioAccel, and has an annual city funding estimated at $1.6 million over a three-year period. The Arizona Republic (Phoenix) (5/4) LinkedInFacebookTwitterEmail this Story
Effective Post-Market Clinical Follow-Up
Post-market surveillance including clinical follow-up, complaints, and vigilance are vital in ensuring compliance with the EU medical device directives, and are an essential component of a 13485 Quality Management System. Learn more about PMS and Vigilance. Visit the PMS Spotlight
  International Developments 
  • Smith & Nephew targets sevenfold growth in Brazil
    Smith & Nephew CEO Olivier Bohuon said in a recent investors' call that his company aims to grow its orthopedic device business in Brazil sevenfold and potentially generate more than $150 million in revenue there. To that end, the company has added a general manager role to oversee its Brazil operations, with plans to boost its presence in that country even more. (Boston) (5/4) LinkedInFacebookTwitterEmail this Story
  Science & Health 
  • Study aims to test use of CT, blood assay in lung cancer diagnosis
    A trial being launched at National Jewish Health in Denver will combine the use of a low-dose CT scan and Oncimmune's EarlyCDT-Lung blood assay as a way to improve early-stage lung cancer detection. The four-year trial will involve 1,600 individuals ages 50 to 75 years and who have a history of smoking one pack a day for at least 20 years, among other criteria. (5/7) LinkedInFacebookTwitterEmail this Story
  Emerging Technologies 
  • Sanofi announces U.S. launch of iPhone-enabled glucometer
    Sanofi said its iBGStar device used to measure and transmit a patient's blood glucose readings to health care providers wirelessly is available commercially in the U.S. The device is billed as the first blood glucose meter to be approved by the FDA that is accessible on the iPhone or iPod touch. (5/4) LinkedInFacebookTwitterEmail this Story
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Top five news stories selected by AdvaMed SmartBrief readers in the past week.

  • Results based on number of times each story was clicked by readers.
  Industry Service Providers 
  Government & Regulatory 
AdvaMed News 
  • Getting to Market in the EU: Making Sense of the Many EU Requirements for Clinical Data
    Tuesday, May 8
    Webinar, 12:00 p.m. - 1:00 p.m. EST
    With the recent medical device scandals in the EU, the commissioner has publicly requested tighter controls. Clinical evaluations are an area that have come under scrutiny in recent years, resulting in multiple changes in the regulations and standards, and creating additional potential consequences for manufacturers who are selling legacy devices or planning to introduce new models in the EU. Device manufacturers need to know what the new requirements are and how they may affect existing and new product certifications. In this live webinar, participants will have the opportunity to hear from the expert presenter, Dr. Dannhorn, on strategies for meeting the new requirements and have the opportunity to ask questions. Visit MTLI online for more information. LinkedInFacebookTwitterEmail this Story
  • Supplier Controls: Regulations and Best Practices Virtual Meeting
    Wednesday, June 6
    Virtual Conference, 10:00 a.m. - 4:00 p.m. EST
    Recent enforcement actions and several product-related tragedies highlight the risks of inadequate vendor selection and oversight, poor communication, misunderstanding of regulations and responsibilities, and a failure to apply the same risk-based approach to supplied components and services that one applies to one's own products and processes. This virtual conference brings together leading authorities from the FDA, industry and critical component suppliers to discuss strategies and best practices for instituting and maintaining a robust and responsible supplier control program. Visit MTLI online for more information. LinkedInFacebookTwitterEmail this Story
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Position TitleCompany NameLocation
Corporate Compliance ManagerEndologix, Inc.Irvine, CA
Sr. Clinical Research AssociateEndologix, Inc.Irvine, CA
Director of Regulatory Systems; CorporateSmith & Nephew, Inc.Andover, MA
Director of Regulatory Systems - CorporateSmith & Nephew, Inc.Memphis, TN
Director of Internal Audit QA/RA - CorporateSmith & Nephew Inc.Memphis, TN
Principal Regulatory Affairs Specialist-Endo-Santa Rosa CAMedtronicSanta Rosa, CA
Senior Business Systems Analyst - 001324Edwards LifesciencesIrvine, CA
Staff Engineer - Cardiac Surgery Systems - 001281Edwards LifesciencesIrvine, CA
Regional Sales DirectorRegenesis Biomedical, Inc.Home based office, CA
Manager, Regulatory Affairs - 1 of 2Johnson & JohnsonFremont, CA
R&D Technical Project ManagerEndologix, Inc.Irvine, CA
Post Market Surveillance Regulatory SpecialistW.L. GorePhoenix, AZ
Regulatory Affairs ProfessionalW.L. GoreFlagstaff, AZ
Director Global Marketing -- Core Brand ManagementCovidienNew Haven, CT
Regulatory Affairs ProfessionalW.L. GoreFlagstaff, AZ
Regulatory Affairs ProfessionalW.L. GoreFlagstaff, AZ
Sr. Quality Engineer - New Product DevelopmentEndologix, Inc.Irvine, CA
Regulatory Affairs Professional — Venous/AccessW.L. GoreFlagstaff, AZ
Vice President – Research, Payment and Health Care Delivery PolicyAdvaMedWashington, DC
Public Affairs CoordinatorAdvaMedWashington, DC
Director, MarketingEndologix, Inc.Irvine, CA
Senior Program Manager - Critical Care - 001311Edwards LifesciencesIrvine, CA
Project Manager, Supplier Development - Transcatheter Heart Valve - 001303Edwards LifesciencesIrvine, CA
Regulatory Affairs Manager Johnson & Johnson Irwindale, CA
Click here to view more job listings.

The word 'listen' contains the same letters as the word 'silent.' "
--Alfred Brendel,
Austrian pianist

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