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November 14, 2012News for medical technology professionals

  Top Story 
 
  • Ikaria gets FDA OK for new software on infant drug delivery device
    The FDA has given Ikaria 510(k) clearance to update software on its Inomax DSIR device designed to deliver the firm's Inomax vasodilator agent, an FDA-approved treatment for infant hypoxic respiratory failure tied to pulmonary hypertension. The firm also gained FDA clearance for three devices used with the Inomax DSIR for noninvasive respiratory care. MassDevice.com (Boston) (11/13) LinkedInFacebookTwitterEmail this 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 
  • Epic Sciences raises $13M for CTCs blood test
    Epic Sciences has raised $13 million, which the company will use to advance its molecular diagnostics technology for detecting circulating tumor cells in the blood. The blood testing system, which the company says offers an alternative to standard biopsies, can be repeated to track disease progression and could also aid in the development of personalized treatments. MedCityNews.com (11/13) LinkedInFacebookTwitterEmail this Story
  • NovoSource eyes 2013 release of total knee replacement device
    NovoSource, which uses lower-cost proven technology to develop orthopedic implants, has gained almost all of its initial financing target of $4 million and is on its second funding round. The startup hopes to launch its total knee replacement device, which is awaiting FDA 510(k) clearance, in the first quarter of next year, and release a hip implant soon after. MedCityNews.com (11/12) 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 
  • Respicardia reports positive trial results for sleep apnea device
    Respicardia said its remede implant designed to treat central sleep apnea has demonstrated the ability to lower by 50% the apnea hypopnea index in patients who received the device in a feasibility trial. The Minnesota startup plans to use the trial data to help advance its device to a pivotal study that will back its premarket approval application with the FDA. MedCityNews.com (11/12) LinkedInFacebookTwitterEmail this Story
  Emerging Technologies 
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  Industry Service Providers 
  • AdvaMed unveils Web portal for veterans seeking medtech jobs
    AdvaMed has announced the launch of an online portal designed to link military veterans with medtech industry stakeholders and give them access to learning opportunities and mentors. The portal, which is part of the group's Medical Technology Veterans Program, is open to all U.S. veterans seeking jobs in the medical device sector. MassDevice.com (Boston) (11/13) LinkedInFacebookTwitterEmail this Story
  • For more: Read the AdvaMed press release about the MVP mentoring Web portal for veterans. LinkedInFacebookTwitterEmail this Story
  Government & Regulatory 
  • FDA approves U.S. study of Kips Bay Medical's surgical mesh
    The FDA has granted Kips Bay Medical investigational device exemption approval to test the use of its eSVS mesh in patients undergoing coronary artery bypass graft surgery. The conditional approval allows the company to add four U.S. clinical sites to an ongoing clinical trial of the device, which is used during CABG procedures to aid in keeping vein grafts open. MassDevice.com (Boston) (11/12) LinkedInFacebookTwitterEmail this Story
  • FDA restricts U.S. import of Hospira's Symbiq infusion pumps
    Hospira has received an FDA notice restricting the importation into the U.S. of its Symbiq drug infusion systems, which are produced in Costa Rica. Hospira said the FDA restriction does not cover imports of its other drug management products and will not have a material effect on the company's ability to meet its financial targets for this year. Reuters (11/14) LinkedInFacebookTwitterEmail this Story
AdvaMed News 
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Position TitleCompany NameLocation
Director of Quality CEA Medical Manufacturing Colorado Springs, CO
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
Clinical Education Manager, Vascular TherapiesCovidienMansfield, MA
Senior/Principal Mechanical EngineerChannel MedsystemsSan Francisco, CA
Director, Global Labeling - 001592Edwards LifesciencesIrvine, CA
Director, Valve Testing - Transcatheter Heart Valve - 001221Edwards LifesciencesIrvine, CA
Compliance Manager, Global DistributionCooperVision, Inc.Rochester, NY or Pleasanton, CA, NY
Associate Director, Regulatory AffairsAbbott LaboratoriesSanta Clara, CA
Senior Marketing Communications Manager - Cardiac Surgery Systems - 001558Edwards LifesciencesIrvine, CA
Packaging Engineer/Project LeaderEndologix, Inc.Irvine, CA
Sr. Manager R & D, Systems Integration EngineeringAbbott LaboratoriesSanta Ana, CA
Regulatory Affairs Associate DirectorAbbott LaboratoriesSanta Clara, CA
Physician Training Program ManagerEndologix, Inc.Irvine, CA
Director Clinical Research - CapnographyCovidienBoulder, CO
Field Service Engineer IRIS International, IncSacramento, CA
Quality EngineerIRIS International, IncChatsworth, CA
Medical and Clinical Laboratory TechnologistIRIS International, IncChatsworth, CA
Senior Mechanical EngineerIRIS International, IncChatsworth, CA
Clinical & Customer Care SpecialistIRIS International, IncLos Angeles, CA
Developmental Cell Biologist/BiochemistIRIS International, IncCarlsbad, CA
Principal Systems Engineer IRIS International, IncChatsworth, CA
Field Service Engineer IRIS International, IncProvidence, RI
Director Professional Medical Education CovidienBoulder, CO
REGULATORY AFFAIRS ENGINEERWelch AllynSkaneateles, NY
Senior Director, QualityAmerican Medical SystemsMinneapolis, MN
Click here to view more job listings.

  SmartQuote 
The best way to find out if you can trust somebody is to trust them."
--Ernest Hemingway,
American author and journalist


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