| November 8, 2012 | News for medical technology professionals |
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- LDR closer to FDA approval for cervical disc device
The FDA has issued an approvable letter to LDR for its Mobi-C system, a metal and polyethylene mobile bearing prosthetic device tailored for use in one- to two-level cervical disc replacement procedures. The company expects to satisfy the remaining approval requirements and release the device in the U.S. next year. BeckersOrthopedicAndSpine.com
(11/7)      
 | Streamline Combination Product Development
This complimentary white paper from Novella Clinical explores combination product regulatory strategies - from classification to market clearance. Combination product sponsors can avoid numerous regulatory hurdles by downloading this white paper now: Clarifying the Regulatory Road for Combination Products. |
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| Business & Market Trends |  |  |
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| Emerging Technologies | | |
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| Government & Regulatory | | |
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- Medtech industry seeks lame-duck session repeal of device tax
Industry stakeholders are bracing for post-election efforts to strike down the 2.3% tax set to be levied against medical devices next year. "[W]e will continue to work to highlight what we think are the negatives of the policy for the industry," said J.C. Scott of the Advanced Medical Technology Association, who noted support from House Democrats and incoming Democratic senators for a repeal of the tax. FierceMedicalDevices
(11/7)
- 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.
- Follow AdvaMed on Google+
 Stay updated on industry news and educational opportunities -– receive an intimate understanding of the key issues affecting innovation, access and the bottom line. Network with industry experts and leaders. Our Google+ page is interactive and incorporates updates from key stakeholders, influencers and industry thought leaders as well as regulatory and policy experts from the FDA and CMS. Follow us on Google+.
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| Position Title | Company Name | Location |
| Director of Quality | CEA Medical Manufacturing | Colorado Springs, CO |
| Director, Global Labeling - 001592 | Edwards Lifesciences | Irvine, CA |
| Director, Valve Testing - Transcatheter Heart Valve - 001221 | Edwards Lifesciences | Irvine, CA |
| 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 |
| Physician Training Program Manager | Endologix, Inc. | Irvine, CA |
| Director Clinical Research - Capnography | Covidien | Boulder, CO |
| Regulatory Affairs Associate Director | Abbott Laboratories | Santa Clara, CA |
| 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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