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April 19, 2012News for medical technology professionals

  Top Story 
  • FDA clears Sree Medical's device for infant imaging
    The FDA has granted Sree Medical Systems 510(k) clearance for Infant Array, a receive-only MRI coil optimized for scanning the brain, heart, spine and torso of infants. The device is designed to work with MRI scanners from Philips, Siemens and GE. (4/17) LinkedInFacebookTwitterEmail this Story
Complimentary Keynote Lunch for AdvaMed subscribers when you register for Mfg4 by Fri., April 20
NASA Deputy Chief Technologist, Jim Adams, discusses where technology is headed and how it will change the way you manufacture in the future. See hundreds of exhibitors demonstrate new products and advanced technology.
Register now for your Free Keynote Lunch. Use code KLT.
  Business & Market Trends 
  • Most medtech execs expect device tax to hurt bottom lines
    A KPMG survey of 190 device maker financial executives finds 61% of respondents expect the 2.3% medical device tax to negatively affect their firms' bottom lines, and 40% are considering price increases and layoffs to offset the levy. AdvaMed has raised concerns that the tax would shift jobs overseas and hurt innovation, and legislators have pushed for its repeal. Reuters (4/18) LinkedInFacebookTwitterEmail this Story
7 keys: Put real-world evidence into action
Life sciences organizations need to know how their therapies work in the real world once clinical trials end. And these seven key components to standardizing real-world data and analytics platforms are how they get started. Read the paper, Institutionalizing Real World Evidence.
  International Developments 
  • Osprey Medical wraps up $20 million IPO in Australia
    Osprey Medical said it has completed an initial public offering valued at $20 million in Australia. The Eden Prairie, Minn.-based firm will use the proceeds from the offering to finance clinical studies and the European release of its Cincor catheter system designed to protect the kidneys of patients undergoing cardiology procedures. Minneapolis/St. Paul Business Journal (4/17) LinkedInFacebookTwitterEmail this Story
  Science & Health 
  Emerging Technologies 
  Featured Content 

  Government & Regulatory 
  • Senate bill aims for FDA reform
    Sens. Tom Coburn, R-Okla., and Richard Burr, R-N.C., introduced a bill aimed at improving the FDA's internal management as well as accountability in regulating drugs and medical devices. The Patients' FDA Act would relax restrictions on companies' ties with physicians and speed up product-approval review. The proposal is meant to be part of the Prescription Drug and User Fee Act reauthorization. Forbes/The Apothecary blog (4/18) LinkedInFacebookTwitterEmail this Story
AdvaMed News 
  • Medical Diagnostics Briefing
    Wednesday, April 25 – Thursday, April 26
    AdvaMed's office, Washington, D.C.
    Diagnostics Briefing is a two-day class exploring the growing role of diagnostics within the biotech industry. Participants will learn about a range of different diagnostic tests and their indications, as well as the basic science and technology behind their development, including an introduction to concepts specific to the diagnostic sector such as sensitivity, specificity, false positives and false negatives. The course will culminate in a detailed overview of the approval process for diagnostic devices, followed by a discussion of current issues impacting the sector, including diagnostic reimbursements, companion diagnostics, and consumer genomics. Visit MTLI online for more information. LinkedInFacebookTwitterEmail this Story
  • The Impact of Smartphones on Standalone Medical Electronics Devices
    Thursday, April 26
    Webinar, 12:00 noon - 1:00 p.m. EST

    Smartphones provide medical technology companies with unprecedented access to an enormous consumer market. To capture this opportunity, they must think carefully about how they develop new technologies and protect their intellectual property innovations. The smartphone juggernaut will impact revenues, design strategies and intellectual property (IP) management for medical devices in the same way it has for many consumer products including cameras, GPS devices and personal media players. Visit MTLI online for more information. LinkedInFacebookTwitterEmail this Story
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Position TitleCompany NameLocation
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
Senior Corporate CounselCovidienNew Haven, CT
Public Affairs CoordinatorAdvaMedWashington, DC
Sr. Manager, Health Initiatives, Thoratec, CorpWest Coast Region, CA
Manager, Sales Strategy - Transcatheter Heart Valve - 001277Edwards LifesciencesIrvine, CA
Clinical Project ManagerEndologix, Inc.Irvine, CA
Director, Health Economics Strategy - Critical Care - 001249Edwards LifesciencesIrvine, CA
Sr. Program Manager, ENT Business DevelopmentMedtronic - Surgical TechnologiesJacksonville, FL
Regulatory Counsel - 001002Edwards LifesciencesIrvine, CA
Regulatory Affairs, Project Manager - Cardiac Surgery Systems- 001280Edwards LifesciencesSalt Lake City, UT
Senior Analyst, CAD - 000614Edwards LifesciencesIrvine, CA
Senior Quality Manager -Transcatheter Heart Valve - 001190Edwards LifesciencesIrvine, CA
Regulatory Affairs Senior Associate -Transcatheter Heart Valve - 001264Edwards LifesciencesSalt Lake City, UT
Director, Clinical Data Management - Transcatheter Heart Valve - 000751Edwards LifesciencesIrvine, CA
Director, Biostatistics - Transcatheter Heart Valve - 001160Edwards LifesciencesIrvine, CA
Finance Manager - Global Corporate Operations - 001240Edwards LifesciencesIrvine, CA
Director, MarketingEndologix, Inc.Irvine, CA
Project Manager, Supplier Development - Transcatheter Heart Valve - 001303Edwards LifesciencesIrvine, CA
Regulatory Affairs Manager Johnson & Johnson Irwindale, CA
Senior Program Manager - Critical Care - 001311Edwards LifesciencesIrvine, CA
Senior Regulatory Affairs Manager with PMA ExperienceCochlear LimitedCentennial, CO
Click here to view more job listings.

Things alter for the worse spontaneously, if they be not altered for the better designedly."
--Francis Bacon,
British author and statesman

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