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January 28, 2013News for medical technology professionals

  Top Story 
 
  • Bioness' device gets FDA OK for treating pediatric foot drop
    Bioness has obtained 510(k) clearance from the FDA for its L300 Foot Drop System to be used in treating foot drop in pediatric patients with cerebral palsy and other neurological diseases. The neurostimulation device, which already has been cleared for adult use, helps restore foot mobility by sending electric signals to stimulate the affected leg's muscles. Medscape (free registration) (1/25) LinkedInFacebookTwitterEmail this Story
Zimmer Reports Launch of its V2F Anterior Fixation System
In an effort to obtain deeper penetration in the spine trauma market, Zimmer (Warsaw, Indiana) has received approval and is launching the Zimmer V2F Anterior Fixation System. It is an implant system for the treatment of thoracolumbar burst fractures, tumors and disc degeneration. Find out the details.

  Business & Market Trends 
  • Cepheid posts 15% revenue growth in fourth quarter
    Cepheid generated $92.4 million in revenues during the fourth quarter, up 15% from the same period last year. Manufacturing issues announced in September have largely been resolved, according to the Sunnyvale, Calif.-based company, and it has been able to stop rationing many of its Xpert products, except for its Xpert Flu test, which has seen increased demand during the flu season. GenomeWeb Daily News (free registration) (1/25) LinkedInFacebookTwitterEmail this Story
  International Developments 
  • EU widens CE mark approval for Medtronic's vascular stent
    European regulators have given Medtronic CE mark approval for its Complete SE vascular stent to be used in the lower extremities, particularly the proximal popliteal and superficial femoral arteries. The self-expanding stent previously was approved for iliac artery applications in Europe. In the U.S., it is approved for iliac artery use and is under review for use in the legs. CardiovascularBusiness.com (1/25) LinkedInFacebookTwitterEmail this Story
  Science & Health 
  • Microfluidic device can run lab-quality HIV tests in 15 minutes
    Samuel Sia, an associate professor at Columbia University, has developed a microfluidic device that he says takes only 15 minutes to perform HIV testing using blood from a finger prick. The handheld device, called the mChip, has been tested on site in Rwanda and could provide HIV patients in remote areas with access to laboratory-quality testing services. Yahoo/Indo-Asian News Service (1/25) LinkedInFacebookTwitterEmail this Story
  Emerging Technologies 
  Hot Topics 

Top five news stories selected by AdvaMed SmartBrief readers in the past week.

  • Results based on number of times each story was clicked by readers.
  Government & Regulatory 
AdvaMed News 
  • Medical Device Reimbursement Workshop
    Tuesday, Feb. 26 – Wednesday, Feb. 27
    Sheraton Crystal City, Arlington, Va.
    Learn from medical device reimbursement experts what new legislative and regulatory changes apply to the area of reimbursement; the key reimbursement issues for medical technology; how Medicare coverage is determined at the national and local levels; the role of MEDCAC; why technology assessments are important; how clinical trial results impact payers; what you need to do to keep up on new reimbursement developments relevant to your products; how to maintain a nimble, dynamic, effective, ongoing reimbursement program; what to do when reimbursement is denied; drill-down coding systems; differences in inpatient and outpatient payment systems; physician fee schedules and product design; how to negotiate CMS coverage; how to plan for the new health care reform landscape deal with comparative effectiveness; and how to manage international reimbursement. Visit MTLI online for more information. LinkedInFacebookTwitterEmail this Story
  • Premarket Approval (PMA) Submissions Workshop
    Thursday, Feb. 28 – Friday, March 1
    Sheraton Crystal City, Arlington, Va.
    Senior industry experts and members of the CDRH device evaluation and bioresearch monitoring staffs lead professionals through the strategic considerations and practical steps of filing a premarket approval, illustrated with real-world case studies. Topics include: the new acceptance and filing review guidance document; the eCopy Program for Medical Device Submissions; strategy development and evidence requirements; productive meetings with the FDA; the mechanics of premarket approval submission development; advisory panels; inspectional activity; and conditions of approval studies. Visit MTLI online for more information. LinkedInFacebookTwitterEmail this Story
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Position TitleCompany NameLocation
Neurovascular Intervention Marketing ManagerAsahi InteccSanta Ana, CA
Regional Service Manager PhilipsHartford, CT
Product Support Specialist IVArthroCare CorporationAustin, TX
Quality Systems ManagerRoche DiagnosticsIndianapolis, IN
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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--William McFee,
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