| November 7, 2012 | News for medical technology professionals |
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 | 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 |  |  |
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| International Developments | | |
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| 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. |
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| Emerging Technologies | | |
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- Testing is under way for Aeris' emphysema device
 The AeriSeal System designed to treat emphysema is undergoing a late-stage clinical study in the U.S., and has been used for the first time in this country at the University of Alabama in Birmingham. The device, created by Aeris, offers a less invasive way to shrink lung volume by delivering foam to diseased parts of the lungs. MedGadget.com
(11/5)      
| Industry Service Providers | | |
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| Government & Regulatory | | |
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- Paragonix seeks 510(k) clearance for cardiac transport device
Paragonix Technologies has filed an application with the FDA seeking 510(k) clearance for the Sherpa Pak Cardiac Transport System. The disposable device, which is used to store donor hearts in transit, releases oxygenated blood to organs and is designed to extend the preservation time for donor hearts from the current four hours to 12 hours. Mass High Tech (Boston)
(11/6)
- 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.
- 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.
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| Position Title | Company Name | Location |
| Director of Quality | CEA Medical Manufacturing | Colorado Springs, CO |
| Compliance Manager, Global Distribution | CooperVision, Inc. | Rochester, NY or Pleasanton, CA, NY |
| Associate Director, Regulatory Affairs | Abbott Laboratories | Santa Clara, CA |
| Senior Marketing Communications Manager - Cardiac Surgery Systems - 001558 | Edwards Lifesciences | Irvine, CA |
| Packaging Engineer/Project Leader | Endologix, Inc. | Irvine, CA |
| Sr. Manager R & D, Systems Integration Engineering | Abbott Laboratories | Santa Ana, CA |
| Regulatory Affairs Associate Director | Abbott Laboratories | Santa Clara, CA |
| Physician Training Program Manager | Endologix, Inc. | Irvine, CA |
| Director Clinical Research - Capnography | Covidien | Boulder, CO |
| Field Service Engineer | IRIS International, Inc | Sacramento, CA |
| Quality Engineer | IRIS International, Inc | Chatsworth, CA |
| Medical and Clinical Laboratory Technologist | IRIS International, Inc | Chatsworth, CA |
| Senior Mechanical Engineer | IRIS International, Inc | Chatsworth, CA |
| Clinical & Customer Care Specialist | IRIS International, Inc | Los Angeles, CA |
| Developmental Cell Biologist/Biochemist | IRIS International, Inc | Carlsbad, CA |
| Principal Systems Engineer | IRIS International, Inc | Chatsworth, CA |
| Field Service Engineer | IRIS International, Inc | Providence, RI |
| Director Professional Medical Education | Covidien | Boulder, CO |
| REGULATORY AFFAIRS ENGINEER | Welch Allyn | Skaneateles, NY |
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| Click here to view more job listings. |
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American cartoonist, columnist and humorist
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| | Recent AdvaMed SmartBrief Issues:
- Tuesday, November 06, 2012
- Monday, November 05, 2012
- Friday, November 02, 2012
- Thursday, November 01, 2012
- Wednesday, October 31, 2012
| | | Lead Editor: Lisa Gough
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