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November 20, 2012News for medical technology professionals

  Top Story 
  Business & Market Trends 
  • Diagnostics maker pulls in $9M
    Metamark Genetics said in a regulatory filing that it secured $9 million as part of a $13 million Series B funding round. The company plans to use the proceeds to complete final clinical validation of two prognostic tests for prostate cancer. Mass High Tech (Boston) (11/16) LinkedInFacebookTwitterEmail this Story
  International Developments 
  • St. Jude wins approval for Portico heart valve in Europe
    St. Jude Medical has obtained CE mark approval to market its Portico transcatheter aortic valve implant in Europe. The device was created to prevent paravalvular leaks and, according to a company press release, it is the “only approved transcatheter valve that can be completely resheathed (the process of bringing the valve back into the delivery catheter), repositioned at the implant site or retrieved before it is released from the delivery system.” (11/19) LinkedInFacebookTwitterEmail this Story
  • U.K. medtech group buys 52% stake in wound healing tech firm
    Westhouse Medical Services hopes to make inroads in the regenerative medicine market and expand its business worldwide by acquiring a 52% stake in Quy Biosciences, a maker of stem cell-based wound healing devices. The U.K.-based Westhouse has various devices under development, including the BreastCheck tool for noninvasive breast cancer diagnosis. Clinica (subscription required) (11/19) LinkedInFacebookTwitterEmail this Story
  Science & Health 
  • Medtronic enrolls first U.S. patient in global heart valve trial
    Medtronic has enrolled the first lower-risk patient from the U.S. in a worldwide clinical study of its CoreValve transcatheter aortic valve implantation device. The study, which will involve about 2,500 patients, aims to compare the use of the CoreValve TAVI device with surgical valve replacement in aortic stenosis patients who are at intermediate risk for open-heart procedures. (Boston) (11/19) LinkedInFacebookTwitterEmail this Story
  Emerging Technologies 
  • Compact microchip uses minimal power to capture ECG, EEG signals
    U.S. engineers have created a microchip about the size of a postage stamp that uses minimal external power to capture ECG and EEG signals. The technology, which produces its electric current from radio waves captured from nearby devices, could provide a cheaper and more compact alternative to similar tools used in monitoring vital signs continuously. (11/16) LinkedInFacebookTwitterEmail this Story
  Industry Service Providers 
  Government & Regulatory 
  • FDA continues to wrestle with personnel challenges, report says
    The FDA has made strides in strengthening its scientific workforce since 2007 through efforts such as enhanced training for medical device reviewers, but it still faces management and staffing challenges, says a Partnership for Public Service report set to be released today. The report urges the FDA to devise targeted recruitment programs, among other recommendations. The Washington Post (11/19) LinkedInFacebookTwitterEmail this Story
  • FDA issues approvable letter to Dune for breast cancer device
    The FDA has issued an approvable letter to Dune Medical Devices for the company's Margin Probe system, which is used with other techniques to detect whether tumors in breast cancer patients have been completely removed. That brings the company closer to obtaining premarket approval for the device, which already has marketing clearance in Europe and Israel. Mass High Tech (Boston) (11/19) LinkedInFacebookTwitterEmail this Story
AdvaMed News 
  • Investigational Device Exemption (IDE) Submissions Workshop
    Wednesday, Feb. 27
    Sheraton Crystal City, Arlington, Va.
    MTLI offers this one-day interactive workshop to lead attendees through the regulatory and practical guidelines governing when an IDE is required, how to compile an effective IDE application, the rules governing clinical studies and human subject protection, Institutional Review Boards, types of pre-IDE meetings and communications, early/expanded access, foreign studies and export, and reimbursement for investigational devices. Visit MTLI online for more information. LinkedInFacebookTwitterEmail this Story
  • Premarket Approval (PMA) Submissions Workshop
    Thursday, Feb. 28 – Friday, March 1
    Sheraton Crystal City, Arlington, Va.
    Completing the MTLI set of interactive submissions workshops, senior industry experts and members of the CDRH device evaluation and bioresearch monitoring staffs lead participants through the strategic considerations and practical steps of filing a PMA, illustrated with real-world case studies. Topics include strategy development and evidence requirements, productive meetings with the FDA, the mechanics of submission development, advisory panels, inspectional activity, conditions of approval studies, and the care and feeding of approved PMAs. Visit MTLI online for more information. LinkedInFacebookTwitterEmail this Story
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Position TitleCompany NameLocation
Director of Quality CEA Medical Manufacturing Colorado Springs, CO
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, 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
Regulatory Affairs Associate DirectorAbbott LaboratoriesSanta Clara, CA
Senior Director, QualityAmerican Medical SystemsMinneapolis, MN
Click here to view more job listings.

A good man with a good conscience doesn't walk so fast."
--Georg Büchner,
German writer

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