| March 6, 2013 | News for medical technology professionals |
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- Philips gets FDA OK for cardiac image-guidance system
The FDA has given Philips 510(k) clearance for its EchoNavigator system, which is used to guide cardiac surgeons and interventional cardiologists during structural heart disease repairs. The technology also has CE mark approval in Europe and works by providing a combined view of live 3D ultrasound and X-ray images. CardiovascularBusiness.com
(3/5)      
 | 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. |
- Medtronic gains expanded EU approval for drug-eluting stent
European regulators have expanded approval for Medtronic's Resolute Integrity device to include one month of dual-antiplatelet treatment, which the company says is the shortest treatment indication for that type of device. Patients who discontinued or interrupted DAP treatment at least a month after implantation showed low rates of stent thrombosis in a clinical study, according to the drug-eluting stent's new labeling. MassDevice.com (Boston)
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- EU approves Bolton Medical's abdominal stent graft
Bolton Medical has earned the CE mark in Europe for its Treovance system, which is used to treat abdominal aortic aneurysms with up to 10 millimeters of proximal neck length or up to 75 degrees of infrarenal neck angle. The stent graft is designed to support multiple configurations that match individual patient anatomies. MedGadget.com
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| Science & Health | | |
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| Emerging Technologies | | |
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- AccuVein unveils new version of vein illumination device
AccuVein has released the AV400, an updated version of its vein illumination system that can visualize the vasculature up to 10 millimeters deep. The handheld device uses a single button for activation and comes with a hands-free mode to enable guided intravenous starts and blood draws, among other features. MedGadget.com
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| Government & Regulatory | | |
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- House Republicans ask FDA to clarify proposed mHealth regulations
House Energy and Commerce Committee Chairman Fred Upton, R-Mich., and other Republican House members have asked FDA Commissioner Dr. Margaret Hamburg via a letter sent on March 1 to provide clarity on the agency's proposal to regulate certain mobile health applications. The legislators expressed concern that manufacturers of mHealth apps, smartphones and tablets could be subjected to the 2.3% tax under the health care law if the FDA decides to regulate them as medical devices. DOTMed.com
(3/6)
- Navigating the SEC's New Conflict Minerals Disclosure Requirements
Thursday, April 11
Webinar, 1:00 p.m. - 2:00 p.m. EST
The SEC recently approved the much-debated conflict minerals due-diligence disclosure rules that were originally developed in the Dodd-Frank Wall Street Reform and Consumer Protection Act. The rule requires public companies to disclose the use of any conflict minerals that “are necessary to the functionality or production of a product manufactured” or “contracted to be manufactured” by that company. While not banning the use of conflict minerals, it does require companies to assess their supply chains and publically disclose their use of the minerals. When your company is producing either components or finished medical devices for customers, you will need to understand the nuances of your supply-chain position in relation to the SEC's rule. Learn more about SEC’s rule in this comprehensive webinar. 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 |
| Sales Area Manager/Sales Rep of Neurovascular Intervention Products | Asahi Intecc USA, Inc. | Any location in US, CA |
| Compliance Consultant 2 | DJO Global | Vista, CA |
| Accreditation Manager | American Association of Tissue Banks | McLean, VA |
| REGULATORY AFFAIRS SPECIALIST | Masimo Corporation | Irvine, CA |
| Director, Health Care Compliance | RTI Biologics | Alachua, FL |
| Director of Global Infrastructure - 002196 | Edwards Lifesciences | Irvine, CA |
| Manager, HCL Regulatory & Quality Compliance | Owens & Minor | Louisville, KY |
| DIR OPERATIONS, Milpitas Site - 130000007R | Abbott | San Jose, CA |
| Engineer, Process Development | ArthroCare Corporation | Irvine, CA |
| Legal Counsel II | Medtronic, Inc. | Minneapolis, MN or Washington, DC, United States |
| Biostatistician - Post Market Surveillance | Johnson & Johnson | Raynham, MA |
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| Click here to view more job listings. |
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- Monday, March 04, 2013
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- Wednesday, February 27, 2013
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