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February 21, 2013News for medical technology professionals

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  Business & Market Trends 
 
  • Cytomedix targets up to $27.5M with 2013 financing plan
    Cytomedix has announced a "comprehensive 2013 financing plan" that it hopes will allow the company to raise as much as $27.5 million. The Maryland-based firm, which specializes in regenerative therapies, said the funding plan will allow it to "confidently execute" its business strategies for this year. MassDevice.com (Boston) (2/20) LinkedInFacebookTwitterEmail this Story
What if a significant amount of your sales are derived from off-label use of your product?
Off-label promotion and off-label use should not be confused. There are risk management precautions you can take. This quick "Ask and Expert" will help you understand the basics. Read More.
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  Industry Insight 

  Science & Health 
  Emerging Technologies 
  • Sanitas' outpatient management system gets FDA OK
    The FDA has approved Sanitas' Wellaho mobile technology platform as a Class II medical device for patients with chronic diseases. The personalized outpatient management device is designed to help chronically ill patients keep track of their conditions, as well as enable doctors to monitor them and oversee their treatment between office visits. San Diego Business Journal (2/20) LinkedInFacebookTwitterEmail this Story
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  Industry Service Providers 
  Government & Regulatory 
  • Senator to consult industry on pay-for to advance device tax repeal
    Amid renewed efforts in the Senate and House to strike down the 2.3% medical device tax, Sen. Elizabeth Warren, D-Mass., plans to consult with the industry about how to make up for the revenue that would be lost if the tax is repealed. "I want to talk to the industry so they understand my basic position, and that is we should never increase taxes on the manufacturing that we're trying to develop in this country," she said. MassDevice.com (Boston) (2/19) LinkedInFacebookTwitterEmail this Story
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
Manager, HCL Regulatory & Quality ComplianceOwens & MinorLouisville, KY
Clinical Operations ManagerCochlear LimitedSydney, Australia
Director of ManufacturingMBio Diagnostics, Inc.Boulder, CO
Director of Global Infrastructure - 002196Edwards LifesciencesIrvine, CA
DIR OPERATIONS, Milpitas Site - 130000007RAbbott San Jose, CA
Regional Service Manager PhilipsHartford, CT
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 
Never help a child with a task at which he feels he can succeed."
--Maria Montessori,
Italian physician and educator


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