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November 13, 2012News for medical technology professionals

  Top Story 
  • GE Healthcare announces U-Systems acquisition
    GE Healthcare has agreed to pay an undisclosed sum to acquire U-Systems, maker of the first ultrasound device cleared in the U.S. as an ancillary tool to mammography in screening for breast cancer in women with more than 50% dense breast tissue. A GE official said the deal will allow the firm to offer the most comprehensive breast care products on the market. American City Business Journals/Milwaukee (11/9) 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 
Bluetooth® technology transforms medical devices
Discover new product possibilities. Leverage a proven, ubiquitous ecosystem of billions of Bluetooth enabled devices. Download the free market study overview containing excerpts from an ABI report on the growth potential of Bluetooth low energy technology in medical and wellness.
  International Developments 
  • Bausch + Lomb to purchase German ophthalmic laser firm
    Technolas Perfect Vision, a German maker of ophthalmic laser systems, will be acquired by Bausch + Lomb in a deal set to be completed by the end of January. The firms are preparing to release the Victus technology, which obtained marketing clearance in the U.S. and Europe in the past year, and are pursuing approval for the product in other markets. Healio (11/10) LinkedInFacebookTwitterEmail this Story
  Science & Health 
  • Researchers say heart cells may work as "biological pacemaker"
    Researchers at the Technion-Israel Institute of Technology said they have created working heart muscles from patients' stem cells and skin cells. Researchers said the cells could function as a "biological pacemaker" to correct irregular or slow heartbeats. "We found that the electrical signal from the heart cells we created synchronized the beat of any surrounding heart tissue," researcher Dr. Oren Caspi said. Researchers are collaborating with heart specialists to move toward clinical trials. The Telegraph (London) (tiered subscription model) (11/11) LinkedInFacebookTwitterEmail this Story
  • Rocket-like fuel powers new ankle prosthesis
    Researchers have developed an ankle prosthesis that is powered by a rocket-like monopropellant fuel and uses a "sleeve muscle actuator" that is smaller, yet more powerful, than a comparable electric motor. The technology may lead to externally powered prostheses that do not require large, heavy batteries. (11/9) LinkedInFacebookTwitterEmail this Story
  Emerging Technologies 
  • Avinger's catheter device for PAD treatment gets FDA OK
    The FDA has cleared Avinger to market the Ocelot System, a chronic total occlusion crossing device that uses optical coherence tomography imaging. The multifunctional catheter is designed to help doctors view inside arteries when treating patients with peripheral artery disease. (11/9) LinkedInFacebookTwitterEmail this Story

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  Industry Service Providers 
  Government & Regulatory 
  • FDA approves abdominal stent graft from Trivascular
    The FDA has granted Trivascular premarket approval for the Ovation stent graft, which is intended to treat weak, bulging or diseased parts of the artery wall in patients undergoing endovascular repair. The approval comes a year after the company received humanitarian device exemption for use of the system in certain patients. (Boston) (11/12) LinkedInFacebookTwitterEmail this Story
  • 64% of medtech firms unhappy with 510(k) process, survey finds
    A survey of 128 medtech firms finds 64% are dissatisfied with the FDA's 510(k) clearance process, largely because of communication delays and perceived inadequate scientific expertise at the agency. Those focused on ophthalmic, ENT and neurological devices expressed the highest discontent, according to the survey sponsored by the MedTech Resource Alliance. (11/12) LinkedInFacebookTwitterEmail this Story
AdvaMed News 
  • 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
  • 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
Learn more about AdvaMed ->About AdvaMed | Join | Courses | Events | Newsroom

Position TitleCompany NameLocation
Director of Quality CEA Medical Manufacturing Colorado Springs, CO
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
Senior Director, QualityAmerican Medical SystemsMinneapolis, MN
Click here to view more job listings.

For the happiest life, rigorously plan your days, leave your nights open to chance."
--Mignon McLaughlin,
American author and journalist

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