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January 23, 2013News for medical technology professionals

  Top Story 
 
  • J&J considers potential sale or spinoff of diagnostics biz
    Johnson & Johnson said it is exploring a possible sale or spinoff of its Ortho Clinical Diagnostics unit, which develops laboratory and blood transfusion testing tools. The company made the disclosure after reporting better-than-expected quarterly profits, driven by strong sales of its artificial hips and knee implants. Reuters (1/22) LinkedInFacebookTwitterEmail this Story
The odds of receiving an Inspectional Observation (483) or a subsequent Warning Letter have been sharply on the rise, and the seriousness of each remains high. How do you respond?
  Business & Market Trends 
  International Developments 
  
Eucomed represents the medical technology industry in Europe. Our mission is to make modern, innovative and reliable medical technology available to more people. AdvaMed and Eucomed partner on issues of mutual interest.
  • NICE endorses MicroLife Medical's blood pressure monitor
    The U.K. National Institute for Health and Clinical Excellence has approved MicroLife Medical Home Solutions' blood pressure monitor for use in primary care settings. The device, called WatchBP Home A, is designed to detect atrial fibrillation in asymptomatic patients early and help prevent the risk of AF-associated stroke. Clinica (subscription required) (1/22) LinkedInFacebookTwitterEmail this Story
  Science & Health 
  • FDA OKs InfraScan's next-gen device to detect brain bleeding
    The FDA has granted InfraScan approval for a next-generation version of its Infrascanner, which employs near-infrared technology to allow for the noninvasive detection of bleeding in the brain. The newly approved device, called the Infrascanner Model 2000, was created in collaboration with the U.S. Marine Corps and Navy and has military specifications, but it could also have applications in sports medicine and other fields. MassDevice.com (Boston) (1/21) LinkedInFacebookTwitterEmail this Story
  • Trial is under way for DioGenix's MS diagnostic test
    A multicenter study being conducted by DioGenix aims to validate whether its MSPrecise test can be used to diagnose multiple sclerosis by identifying changes in cerebrospinal fluid DNA that are linked to the autoimmune disease. The trial, which will enroll up to 160 patients, will be used to help bring the test to market in a couple of years. MedCityNews.com (1/22) LinkedInFacebookTwitterEmail this Story
  • FSU receives VA grant to improve socket design
    A two-year, $4.4 million Department of Veterans Affairs contract has charged Florida State University, along with four other groups, to work on improving prosthetic socket design for amputee veterans. The partners, which include Prosthetic and Orthotic Associates, are developing prototypes using “Socket Optimized for Comfort with Advanced Technology,” seeking to address the discomfort caused by poor fit, excessive heat and moisture. Tallahassee Democrat (Fla.) (tiered subscription model) (1/17) LinkedInFacebookTwitterEmail this Story
  Emerging Technologies 
  Industry Service Providers 
  Government & Regulatory 
AdvaMed News 
  • 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
  • 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
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
Click here to view more job listings.

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--Michel de Montaigne,
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