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February 15, 2013News for medical technology professionals

  Top Story 
  • Second Sight gains FDA approval for first retinal implant
    The FDA has granted Second Sight Medical Products approval for its Argus II system. The device is said to be the first implantable system approved for treating patients with retinitis pigmentosa, a rare genetic eye condition that can cause blindness. Reuters (2/14), Forbes (2/14) LinkedInFacebookTwitterEmail this Story
  Business & Market Trends 
  International Developments 
  • EU's medical device regulations to face public scrutiny
    Over the next two weeks, the EU's reworking of its medical device and in vitro diagnostics regulatory system will undergo public scrutiny. While many critics of the EU's regulation of medical devices look to the U.S. FDA premarket approval system for guidance, others, such as the German industry group Spectaris, caution against overestimating the effectiveness of the FDA, saying the EU should take a measured, cautious approach to revamping its medtech regulation. Clinica (subscription required) (2/11) LinkedInFacebookTwitterEmail this Story
  Science & Health 
  • Qiagen will develop assays for Lilly's drugs
    Qiagen agreed to develop companion diagnostic tests for Eli Lilly & Co.'s experimental and approved drugs. The alliance expands Lilly's "capabilities to more quickly and cost-effectively bring innovative new medicines, alongside advanced diagnostics, to patients worldwide who are waiting," said Daniel Skovronsky, Lilly's vice president of tailored therapeutics. GenomeWeb Daily News (free registration) (2/13) LinkedInFacebookTwitterEmail this Story
  Emerging Technologies 
  Industry Service Providers 
  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
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.

If you want to live a happy life, tie it to a goal. Not to people or things."
--Albert Einstein,
German-born theoretical physicist

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