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February 5, 2013News for medical technology professionals

  Top Story 
 
  • Medtronic's next-gen heart implants clear EU regulatory hurdle
    European regulators have granted Medtronic CE mark approval to market a next-generation line of its Evera implantable cardioverter defibrillators. The newly approved product line comes with a more contoured and thinner design for improved fit within the body and as much as 11 years of battery life, according to the company. MassDevice.com (Boston) (2/4) LinkedInFacebookTwitterEmail this Story
Exporting to Europe: Medical Device Requirements
Join BSI to gain a basic understanding of the CE Marking regulatory process and the impact the Medical Device Directive (MDD) requirements have on marketing a new medical device in the EU. Learn the different medical device risk classifications and when you need a Notified Body. Register Today!
  Business & Market Trends 
  • Device tax leads Smith & Nephew to plan job cuts
    Smith & Nephew said it plans to lay off nearly 100 employees at its manufacturing facilities in Massachusetts and Tennessee. The company, which develops orthopedic reconstruction systems, attributes the job cuts to the 2.3% medical device tax that went into effect Jan. 1. The Huffington Post (2/4) LinkedInFacebookTwitterEmail this Story
FEATURED ARTICLE: 10 Small-Business Predictions for 2015
Things are looking up for small businesses in 2015. We count down the 10 ways you can get ahead in the New Year. Read the article.

  International Developments 
  • Puerto Rico could extend medical device tax
    A 4% tax levied by Puerto Rico on manufacturers of medical devices in 2010 was to decrease until it hit 1% in 2016, but now government officials want to extend the tax at 4% through 2017. Medical devices represent 13% of manufacturing in Puerto Rico, a commonwealth of the U.S. AdvaMed opposes the tax, and the group's President and CEO Stephen J. Ubl said that continuing the tax "will significantly impact device manufacturers' ability to maintain and grow their manufacturing facilities on the island." MassDevice.com (Boston) (2/1) LinkedInFacebookTwitterEmail this Story
  • For more: Read the statement from AdvaMed President and CEO Stephen J. Ubl about his group's opposition to the extension of the medical device tax in Puerto Rico.
  Science & Health 
  • GE, NFL partner to develop imaging systems to ID head trauma
    The National Football League has entered a four-year, $50 million partnership with General Electric for the creation of imaging technology that would improve diagnosis of concussions. The initiative also aims to promote better protection of the brain for players, and the efforts could result in new technologies within a few years. The first part of the project will devote $30 million over four years to the development of imaging systems to identify head trauma. The New York Times (tiered subscription model) (2/2) LinkedInFacebookTwitterEmail this Story
  Emerging Technologies 
  • U.S. clinical trial begins for Endosense's ablation catheter
    The University of Virginia Medical Center in Charlottesville has become the first in the U.S. to use Endosense's TactiCath Quartz ablation catheter as part of an investigational device exemption clinical trial of the device. Trial results will be used to back the company's FDA premarket approval application for the system, which it aims to file during the fourth quarter of this year. AuntMinnie.com (free registration) (2/4) LinkedInFacebookTwitterEmail this Story
  Industry Service Providers 
  • Teleflex, Ivera sign supply deals with hospital GPO
    Teleflex has received a contract from HealthTrust to provide the hospital group purchasing organization with its Weck line of ligation systems. Separately, Ivera Medical has struck a deal to supply the hospital GPO with its Curos Port Protector intended to prevent catheter-related bloodstream infections and bacterial contamination. MassDevice.com (Boston) (2/4) LinkedInFacebookTwitterEmail this Story
  Government & Regulatory 
  • Agency releases final Sunshine Act rule
    CMS has released the final rule for the Physician Payments Sunshine Act, requiring drug and device companies to gather information on gifts, payments and other value transfers provided to doctors and teaching hospitals starting Aug. 1. The rule also requires manufacturers and group purchasing organizations to report ownership and investment interests by physicians. Modern Healthcare (subscription required) (2/1) LinkedInFacebookTwitterEmail this Story
  • FDA OKs MRI device as companion Dx for iron overload drug
    Resonance Health has received the FDA's OK for its FerriScan R2-MRI system to be sold as a companion diagnostic for Novartis drug Exjade, which is used to treat iron overload in patients suffering from genetic blood disorders. The device is intended to help pinpoint which patients with nontransfusion-dependent thalassemia would best benefit from the drug. AuntMinnie.com (free registration) (2/4) 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
Learn more about AdvaMed ->About AdvaMed | Join | Courses | Events | Newsroom

 
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Click here to view more job listings.

  SmartQuote 
Failure changes for the better, success for the worse."
--Seneca the Younger,
Roman philosopher, statesman and playwright


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