| February 13, 2013 | 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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- Boston Scientific could pay about $75M for device tax this year
The 2.3% medical device tax will cost Boston Scientific about $75 million this year, President and CEO Michael Mahoney said at a meeting with analysts Tuesday. The company hopes to overcome this and other challenges by streamlining its operations, building its worldwide presence and increasing its foothold in fast-growing technology markets, he said. MassDevice.com (Boston)
(2/12)      
| 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. |
- CurveBeam gains EU approval for foot and ankle CT scanner
European regulators have granted CurveBeam approval to market its PedCAT CT scanner, which is used to generate 3D foot and ankle images during weight- and nonweight-bearing evaluations for preoperative planning and other applications. The device uses cone-beam technology, which allows it to deliver a lower radiation dose than conventional CT systems and be small enough to fit in a doctor's office. MedGadget.com
(2/12)
- Sweden aligns medtech software policies with EU rules
The Swedish Medical Products Agency has released new guidance outlining its process for regulating standalone software classified as medical devices in the country. The revised guidance is intended to clear up "remaining ambiguities" involving the regulation of such products as well as align it with the European Commission's rules on medtech software. Clinica (subscription required)
(2/11)
| Science & Health | | |
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| Emerging Technologies | | |
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- Advanced heart stent from Boston Scientific debuts in Europe
Boston Scientific is launching its Promus PREMIER coronary stent, which is made of platinum chromium alloy, in Europe. The device, which is not yet available commercially in the U.S. and Japan, releases the drug everolimus and is coated with a fluorinated co-polymer to give it flexibility. MedGadget.com
(2/12)
| Industry Service Providers | | |
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| Government & Regulatory | | |
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- Medical Device Tax Workshop
Wednesday, March 13 -- Thursday, March 14
Sheraton Crystal City, Arlington, Va.
Join tax professionals in discussing how to implement the new medical device 2.3% excise tax. Medical device tax experts discuss how to implement these tax changes. Interact in educational sessions and collaborative lessons, and discuss with other industry affiliates concerns with the medical device excise tax. Medical device tax leaders navigate you through these tax changes by identifying key issues such as: identifying taxable medical devices; taxable and non-taxable uses; combination products; bundled services; exemptions; reporting; exclusions; rebates; payment; penalties; accounting systems; and ruling guidance. Visit MTLI online for more information.
- 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 |
| Neurovascular Intervention Marketing Manager | Asahi Intecc | Santa Ana, CA |
| DIR OPERATIONS, Milpitas Site - 130000007R | Abbott | San Jose, CA |
| Director of Manufacturing | MBio Diagnostics, Inc. | Boulder, CO |
| Director of Global Infrastructure - 002196 | Edwards Lifesciences | Irvine, CA |
| Engineer, Process Development | ArthroCare Corporation | Irvine, CA |
| Regional Service Manager | Philips | Hartford, CT |
| Sr. QA Manager - Quality Systems (Santa Barbara) | Allergan | Santa Barbara, CA |
| Legal Counsel II | Medtronic, Inc. | Minneapolis, MN or Washington, DC, United States |
| Product Support Specialist IV | ArthroCare Corporation | Austin, TX |
| Director of Clinical Affairs | Endologix | Irvine, CA |
| Sr. Clinical Research Associate | Endologix, Inc. | Irvine, CA |
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| Click here to view more job listings. |
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British author
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| | Recent AdvaMed SmartBrief Issues:
- Tuesday, February 12, 2013
- Monday, February 11, 2013
- Friday, February 08, 2013
- Thursday, February 07, 2013
- Wednesday, February 06, 2013
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