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February 22, 2013News for medical technology professionals

  Top Story 
  • Survey: Medtech firms could cut jobs, R&D to manage device tax
    An Emergo Group survey of 650 senior medtech executives found that 11% would shrink their workforce to help manage the costs of the 2.3% medical device tax, while about 12% would cut their research and development funding. Meanwhile, more than 40% of respondents said they would deal with the tax by raising product prices. MassDevice.com (Boston) (2/21) LinkedInFacebookTwitterEmail this Story
  Business & Market Trends 
  • Gynesonics raises $21M for device to treat uterine fibroids
    A Series D financing round has pulled in $21 million for California-based Gynesonics, which specializes in women's health devices. The money will be used to advance the clinical development and commercialization of the company's VizAblate ultrasound-guided system, which is intended as a minimally invasive alternative to hysterectomy in treating uterine fibroids. MassDevice.com (Boston) (2/20) LinkedInFacebookTwitterEmail this Story
  International Developments 
  Science & Health 
  • Covidien wraps up patient enrollment for iliac stent trials
    Covidien has concluded patient enrollment in a series of clinical studies to determine whether its self-expanding or balloon expandable stents are safe and effective in treating peripheral arterial disease in the iliac arteries. The trials involve 23 clinical sites in Europe and the U.S. RTT News (2/20) LinkedInFacebookTwitterEmail this Story
  Emerging Technologies 
The Buzz(CORPORATE ANNOUNCEMENTS)

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  Government & Regulatory 
AdvaMed News 
  • 510(k) Submissions Workshop
    Monday, Feb. 25 -- Tuesday, Feb. 26
    Sheraton Crystal City, Arlington, Va.
    Join quality and regulatory professionals at this interactive 510(k) workshop. Industry experts and key personnel from the FDA CDRH and CBER 510(k) staff inform you in detail on current FDA updates to the 510(k) process (eCopy Program for Medical Device Submissions); a step-by-step walk-through of the 510(k) regulatory guidelines; 510(k) practical steps and strategic considerations for determining a product's regulatory route to market; identifying a predicate device; planning and assembling a 510(k) submission; interacting with the FDA during the 510(k) review process; 510(k) post-clearance issues; and the Refuse to Accept Policy for 510(k)s.  Visit MTLI online for more information. LinkedInFacebookTwitterEmail this Story
  • Investigational Device Exemption (IDE) Submissions Workshop
    Wednesday, Feb. 27
    Sheraton Crystal City, Arlington, Va.
    FDA staff leaders and industry experts at this interactive workshop will lead professionals through the regulatory and practical guidelines governing when an investigational device exemption is required; how to compile effective investigational device exemption applications; the eCopy Program for Medical Device Submissions; the rules governing clinical studies and human subject protection; Institutional Review Boards; types of pre- investigational device exemption meetings and communications; early/expanded access; foreign studies and export; and reimbursement for investigational devices. Visit MTLI online for more information. LinkedInFacebookTwitterEmail this Story
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Position TitleCompany NameLocation
Neurovascular Intervention Marketing ManagerAsahi InteccSanta Ana, CA
Director, Health Care ComplianceRTI BiologicsAlachua, FL
Clinical Operations ManagerCochlear LimitedSydney, Australia
Director of ManufacturingMBio Diagnostics, Inc.Boulder, CO
Director of Global Infrastructure - 002196Edwards LifesciencesIrvine, CA
Manager, HCL Regulatory & Quality ComplianceOwens & MinorLouisville, KY
Regional Service Manager PhilipsHartford, CT
DIR OPERATIONS, Milpitas Site - 130000007RAbbott San Jose, CA
Engineer, Process DevelopmentArthroCare CorporationIrvine, CA
Sr. QA Manager - Quality Systems (Santa Barbara)AllerganSanta Barbara, CA
Legal Counsel IIMedtronic, Inc.Minneapolis, MN or Washington, DC, United States
Biostatistician - Post Market Surveillance Johnson & JohnsonRaynham, MA
Click here to view more job listings.

  SmartQuote 
You can do anything in this world if you are prepared to take the consequences."
--W. Somerset Maugham,
British writer


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