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November 12, 2012News for medical technology professionals

  Top Story 
  • Medtronic gets wider FDA OK for thoracic aorta lesions device
    Medtronic has received expanded premarket approval from the FDA for its Valiant stent graft to be used for treating all descending thoracic aorta lesions, except dissections. Previously, the device, delivered using the Captivia system, was approved only for fusiform aneurysms and saccular aneurysms/penetrating ulcers of the DTA in certain patients. (Boston) (11/9) LinkedInFacebookTwitterEmail this Story
Siemens Launches Application to Help Deal with Hospital Anxiety
Sometimes patients can develop quite a bit of anxiety when waiting to be treated in the hospital or in their physician’s office. The cold sterile walls could impact patients negatively. It’s a condition that Siemens in partnership with Dream Think Imagine, is seeking to overcome with a newly launched product – ImageScapes. Find out the details.

  Business & Market Trends 
  • Boston Scientific unveils relocation plan in Mass.
    Boston Scientific has announced plans to transfer its headquarters from Natick to Marlboro, Mass., moving about 800 jobs to the new head office beginning next spring. "Consolidating our ... facilities is expected to foster greater collaboration and efficiency, benefiting our employees, our customers and, ultimately, the patients they treat," CEO Mike Mahoney said. Boston Herald (11/9) LinkedInFacebookTwitterEmail this Story
  • Mass. spinal implant maker pulls in $11.6 million
    Intrinsic Therapeutics has secured $11.6 million in a round of financing from 11 investors. The Woburn, Mass.-based company, which aims to raise a total of $20 million, is the maker of the Barracaid implantable spinal device designed to treat herniated lumbar discs. Mass High Tech (Boston) (11/9) LinkedInFacebookTwitterEmail this Story
  International Developments 
  • Singapore firm unveils rapid TB detection chip
    Veredus Laboratories has introduced VereMTB, a lab-on-a-chip used to identify different mutations of mycobacterium linked to tuberculosis and nine other clinically relevant mycobacteria. The multiplexed device uses sputum samples coughed up by patients to detect the specific mycobacterium in about three hours. (11/9) LinkedInFacebookTwitterEmail this Story
  • Global Harmonization Task Force to formally end Dec. 31
    The Global Harmonization Task Force will officially cease operations Dec. 31. The task force, established in 1992 to harmonize regional and national medical device regulatory programs, has been replaced with a regulators-only entity, the International Medical Device Regulators Forum, which will carry on some of the GHTF's activities. Clinica (subscription required) (11/9) LinkedInFacebookTwitterEmail this Story
  Science & Health 
  • Vital raises funds to advance bio-artificial liver to Phase III trials
    A regulatory filing disclosed that Vital Therapies has gained $86.1 million since September, bringing the company's total fundraising to about $150 million. The company announced in September that the money will allow it to move its Elad bio-artificial liver to three pivotal Phase III trials in 375 patients with fulminant hepatic failure and acute alcoholic hepatitis. (11/9) LinkedInFacebookTwitterEmail this Story
  • New blood test helps identify babesiosis in donated blood
    Initial findings from studies of Imugen's experimental blood tests to screen blood donors for babesiosis were presented at this year's AABB Annual Meeting. At the time of the meeting, about 20,000 blood donors had been tested for the disease using a new serologic test method and nucleic acid tests. The testing identified 69 units of blood that were potentially tainted with the disease and were removed from the blood supply. The studies are set to be completed early next year. (11/8) LinkedInFacebookTwitterEmail this Story
  Emerging Technologies 
  • Plasma preparation device from Cytomedix wins FDA nod
    Cytomedix has obtained 510(k) clearance from the FDA to market its Angel platelet rich plasma technology, which is used to process small blood samples or mixtures of bone marrow aspirate and blood. The system is designed to allow the quick and safe preparation of concentrated plasma in clinical settings. (11/8) LinkedInFacebookTwitterEmail this Story

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  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.
  Industry Service Providers 
  • N.J. hospital adopts GE's breast cancer imaging device
    GE Healthcare has installed its SenoBright system at Camden, N.J.-based Cooper University Hospital, the first area facility to provide the advanced tool for breast cancer scanning. GE said the technology lets doctors run additional tests on the same Senographe device, perform diagnosis with scans that simulate standard mammograms and access results in a similar format. (free registration) (11/12) LinkedInFacebookTwitterEmail this Story
  Government & Regulatory 
AdvaMed News 
  • Foreign Corrupt Practices Act (FCPA) Seminar for Medical Devices
    Tuesday, Nov. 13
    AdvaMed headquarters, Washington, D.C.
    Learn the latest trends in FCPA enforcement and lessons learned on third-party compliance management. Participate in a panel discussion with industry experts about FCPA risks in Brazil, China and India, and learn how to navigate other global anti-corruption risks. Network with industry experts, receive guidance and obtain up-to-the-minute information on the FCPA. Register for the seminar. LinkedInFacebookTwitterEmail this Story
  • Physician Payment Sunshine Act Seminar for Medical Devices
    Wednesday, Nov. 14
    AdvaMed headquarters, Washington, D.C.
    Discuss the implementation issues and challenges of interacting with customers during the statutory review period. Achieve a better understanding of identifying and tracking payments to covered recipients. Obtain step-by-step guidance on classifying payment types such as education expenses, consultant fees, and meals and travel. Learn more about disclosure reporting. Network with industry experts and leaders who will be available to discuss your tracking systems, reporting methods and review processes, and who will provide guidance on potential solutions to your compliance challenges. Register for the seminar. LinkedInFacebookTwitterEmail this Story
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Position TitleCompany NameLocation
Director of Quality CEA Medical Manufacturing Colorado Springs, CO
Senior Director, QualityAmerican Medical SystemsMinneapolis, MN
Clinical Education Manager, Vascular TherapiesCovidienMansfield, MA
Senior/Principal Mechanical EngineerChannel MedsystemsSan Francisco, CA
Director, Global Labeling - 001592Edwards LifesciencesIrvine, CA
Director, Valve Testing - Transcatheter Heart Valve - 001221Edwards LifesciencesIrvine, CA
Compliance Manager, Global DistributionCooperVision, Inc.Rochester, NY or Pleasanton, CA, NY
Associate Director, Regulatory AffairsAbbott LaboratoriesSanta Clara, CA
Senior Marketing Communications Manager - Cardiac Surgery Systems - 001558Edwards LifesciencesIrvine, CA
Packaging Engineer/Project LeaderEndologix, Inc.Irvine, CA
Sr. Manager R & D, Systems Integration EngineeringAbbott LaboratoriesSanta Ana, CA
Regulatory Affairs Associate DirectorAbbott LaboratoriesSanta Clara, CA
Physician Training Program ManagerEndologix, Inc.Irvine, CA
Director Clinical Research - CapnographyCovidienBoulder, CO
Field Service Engineer IRIS International, IncSacramento, CA
Quality EngineerIRIS International, IncChatsworth, CA
Medical and Clinical Laboratory TechnologistIRIS International, IncChatsworth, CA
Senior Mechanical EngineerIRIS International, IncChatsworth, CA
Clinical & Customer Care SpecialistIRIS International, IncLos Angeles, CA
Developmental Cell Biologist/BiochemistIRIS International, IncCarlsbad, CA
Principal Systems Engineer IRIS International, IncChatsworth, CA
Field Service Engineer IRIS International, IncProvidence, RI
Director Professional Medical Education CovidienBoulder, CO
Click here to view more job listings.

I observe the physician with the same diligence as the disease."
--John Donne,
British poet, satirist, lawyer and cleric

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