| November 28, 2012 | News for medical technology professionals |
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- GE gets FDA OK for liver embolization imaging device
The FDA has given GE Healthcare 510(k) clearance to market its FlightPlan for Liver imaging tool, which aids in planning liver embolization procedures. The device, which already is being marketed in Asia, Europe and Latin America, creates a 3D road map of tumor-feeding blood vessels to help doctors direct a catheter to the targeted artery. MassDevice.com (Boston)
(11/27)      
| Business & Market Trends |  |  |
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- Funding round brings in $18 million for TriReme Medical
TriReme Medical has secured $18 million in a round of financing led by Singaporean firm Luminor Capital. The California company, which specializes in peripheral and coronary devices that are minimally invasive and are used for treating complicated lesions, will use the money to develop its dilation catheters and expand its global commercial infrastructure. MedCityNews.com
(11/27)
- Calif. heart device startup hopes to raise $4 million
 CHF Technologies, which operates as BioVentrix, is looking to obtain $4 million in a funding round. The San Ramon, Calif.-based startup has developed the Revivent myocardial anchoring system, which is used to promote functional improvement of the heart's left ventricle in patients with congestive heart failure. MedCityNews.com
(11/27)
| 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. |
- EU regulators OK insulin delivery system from CeQur
European regulators have granted CeQur CE mark approval to market its device designed to replace daily insulin injections in type 2 diabetes patients. The device, which can administer insulin consistently for three days, is targeted for a limited European release next year and a broader launch in 2014. Mass High Tech (Boston)
(11/27)
| Science & Health | | |
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- Prosthetic advances for the military benefit civilians
Initially developed for the military, Ottobock's Genium Bionic Prosthetic System is now available to civilians. Philadelphia resident Rebecca Levenberg, who lost her left leg above the knee two years ago, has started a blog about her experiences with the device, which features a microprocessor-controlled knee. "I am going to take step after step until I’ve literally walked a thousand miles," she writes. KYW-TV (Philadelphia)/CBS News
(11/26)
| Emerging Technologies | | |
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| Government & Regulatory | | |
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- Device tax should be included in fiscal cliff talks, GOP leader says
The industry push to repeal the 2.3% medical device tax has gained support from House Majority Leader Eric Cantor, R-Va., who said the tax and health care law should be included in fiscal cliff negotiations. "There’s taxes on the medical device industry that cause people to lose access perhaps to certain kinds of treatment. That will actually provide a lot of harm to job growth in a very growing industry in this country -- the medical device area," he said. MedCityNews.com
(11/27), MinnPost.com
(11/26)
- FDA streamlines medical device guidance on new website
How the FDA publishes and asks for feedback on the guidance documents crafted by the Center for Devices & Radiological Health will be simplified thanks to the agency's new medical device guidance website. Industry stakeholders can use the website to post suggestions, recommend draft language and submit input on which topics to prioritize for guidance next year. MassDevice.com (Boston)
(11/27)
- Premarket Approval (PMA) Submissions Workshop
Thursday, Feb. 28 – Friday, March 1
Sheraton Crystal City, Arlington, Va.
Completing the MTLI set of interactive submissions workshops, senior industry experts and members of the CDRH device evaluation and bioresearch monitoring staffs lead participants through the strategic considerations and practical steps of filing a PMA, illustrated with real-world case studies. Topics include strategy development and evidence requirements, productive meetings with the FDA, the mechanics of submission development, advisory panels, inspectional activity, conditions of approval studies, and the care and feeding of approved PMAs. 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 |
| Payer Relations Director | Sonitus Medical Inc | San Mateo, CA |
| Director of Quality | CEA Medical Manufacturing | Colorado Springs, CO |
| Clinical Education Manager, Vascular Therapies | Covidien | Mansfield, MA |
| Manager, Grassroots and Member Engagement, Government Affairs | AdvaMed | Washington, DC |
| Associate Vice President, Global Strategy and Analysis (Asian Region) | AdvaMed | Washington, DC |
| Manager, Regulatory Affairs | Sequenom, Inc. | San Diego, CA |
| Senior/Principal Mechanical Engineer | Channel Medsystems | San Francisco, CA |
| Director, Valve Testing - Transcatheter Heart Valve - 001221 | Edwards Lifesciences | Irvine, CA |
| Senior Director, Quality | American Medical Systems | Minneapolis, MN |
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| Click here to view more job listings. |
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