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January 24, 2013News for medical technology professionals

  Top Story 
  • NContact scores 510(k) clearance for next-gen cardiac system
    The FDA has cleared nContact to market EPi-Sense, a next-generation version of the company's VisiTrax heart ablation system. The newly cleared technology comes with advanced sensors, which transmit electrical signals to help electrophysiologists position the device better when performing cardiac ablation surgery. (Boston) (1/23) LinkedInFacebookTwitterEmail this Story
 Free White Paper: FDA: 21 CFR PART 11 & EU: GMP - ANNEX 11
The EU's Annex 11 focuses on risk management throughout the entire lifecycle of the computerized GMP process. Review this comparison between the requirements set forth in 21 CFR Part 11 and in Annex 11, along with Pilgrim Software's own interpretation of the requirements. DOWNLOAD THIS PAPER TODAY.

  Business & Market Trends 
  • Report: U.S. implant market could be valued at $73.9B in 5 years
    The U.S. market for implantable medical devices is expected to rise from $43.1 billion in 2011 to $73.9 billion by 2018, according to a Transparency Market Research report. Growth in all segments of the implant market, particularly in the orthopedics arena, will be driven by the aging population and the growing incidence of chronic diseases, the report notes. (1/23) LinkedInFacebookTwitterEmail this Story
  • Hologic reorganizes top tier
    Hologic has tapped Rohan Hastie to serve as its new senior vice president and general manager for diagnostics, replacing Carl Hull, who is stepping down on Feb. 15. Hologic also has appointed Eric Tardif senior VP of corporate strategy. He previously served as senior VP of commercial operations for diagnostics. GenomeWeb Daily News (free registration) (1/23) LinkedInFacebookTwitterEmail this Story
  International Developments 
  Industry Insight 

  Science & Health 
  • Cordis reports positive trial results for vascular stent
    Cordis said its S.M.A.R.T. vascular stent proved safe and effective in treating obstructive superficial femoral artery disease in a clinical study. The study noted that 80.3% of patients did not require clinically driven target lesion revascularization within two years of receiving the device, and no major adverse events were reported 30 days after the initial procedure. RTT News (1/21) LinkedInFacebookTwitterEmail this Story
  Emerging Technologies 
  • Welch Allyn's iPhone-based eye testing tool gets FDA OK
    Welch Allyn has secured 510(k) clearance from the FDA to market a device that links an ophthalmoscope, which is used to spot glaucoma and other eye conditions, with an iPhone. The iExaminer Adapter comes with a companion iPhone application to enable the sharing and printing of images. (1/23) LinkedInFacebookTwitterEmail this Story

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  Government & Regulatory 
AdvaMed News 
  • Medical Device Tax Workshop
    Wednesday, March 13 -- Thursday, March 14
    Sheraton Crystal City, Arlington, Va.

    Join tax professionals in discussing how to implement the new medical device 2.3% excise tax. Medical device tax experts discuss how to implement these tax changes. Interact in educational sessions and collaborative lessons, and discuss with other industry affiliates concerns with the medical device excise tax. Medical device tax leaders navigate you through these tax changes by identifying key issues such as: identifying taxable medical devices; taxable and non-taxable uses; combination products; bundled services; exemptions; reporting; exclusions; rebates; payment; penalties; accounting systems; and ruling guidance. Visit MTLI online for more information. LinkedInFacebookTwitterEmail this Story
  • Join the AdvaMed-MTLI LinkedIn group!
    Build close relationships with member companies, both small and large, and receive an intimate understanding of the key issues affecting innovation, access and the bottom line. Interact in discussions that leverage the leadership and expertise of the medical technology industry. This social group is full of key stakeholders, influencers and industry thought leaders as well as regulatory and policy experts from the FDA and CMS. Aside from practical learning opportunities, this LinkedIn group provides the premier opportunity to network with key players from virtually every aspect of the industry. Link to the AdvaMed MTLI LinkedIn group page. LinkedInFacebookTwitterEmail this Story
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Position TitleCompany NameLocation
Quality Systems ManagerRoche DiagnosticsIndianapolis, IN
Product Support Specialist IVArthroCare CorporationAustin, TX
Director of Clinical AffairsEndologixIrvine, CA
Sr. Clinical Research AssociateEndologix, Inc.Irvine, CA
Area Reimbursement Manager (Central U.S. or Northeast U.S.)SI-BONE, IncMultiple Locations, United States
Program Director, Regulatory AffairsJohnson & JohnsonFremont, CA
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All news is an exaggeration of life."
--Daniel Schorr,
American journalist

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