| December 11, 2012 | News for medical technology professionals |
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- Ethicon unit's surgical sealant patch gains FDA approval
The FDA has granted Ethicon Biosurgery, an Ethicon unit, approval for its EVARREST system designed to help control problematic, surgery-related bleeding. The fibrin sealant patch, which is used with manual compression, has been approved as an ancillary tool to hemostasis for soft tissue bleeding in patients undergoing pelvic surgery and other procedures. BeckersASC.com
(12/10)      
| Andain Moves Forward with Disposable Insulin Pump |
| Andain (Beverly Hills, California), a company specializing in technologies for biotech, medical and life sciences fields, reported the development of its miniature fully disposable and programmable insulin pump. The pump is fully disposable and is like a small band-aid sized patch. Find out the details. |
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| Business & Market Trends |  |  |
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- Ohio startup seeks funds for device to cut intubation risks
Miach Medical is seeking to raise money as it develops a third-generation prototype of a device that can be used to reduce intubation complications by equipping feeding and breathing tubes with pressure sensors. "Our goal is really to enhance monitoring of people who require ventilation support or feeding tubes, especially over the long term," company co-founder James Reynolds said. MedCityNews.com
(12/10)
| International Developments | | |
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- Gore clears EU hurdle for endovascular stent graft
European regulators have granted W.L. Gore & Associates CE mark approval to market the Excluder AAA endoprosthesis, an endovascular stent graft for treating patients with abdominal aortic aneurysms. The device, designed for patients whose infrarenal aortic inner neck measures 19 to 32 millimeters in diameter, is inserted through a small incision in the leg to close an aneurysm. MassDevice.com (Boston)
(12/7)
- EU regulators approve urology device from Mauna Kea
Mauna Kea Technologies has earned CE mark approval in Europe to market Cellvizio UroFlex, which the company says is the first optical biopsy probe intended for urology uses. The device employs the firm's Cellvizio microscopy system, the use of which thus far has been limited to lung and gastrointestinal biopsies, to aid clinicians in diagnosing and monitoring bladder cancer. MedGadget.com
(12/7)
| Science & Health | | |
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| Emerging Technologies | | |
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| The Buzz(CORPORATE ANNOUNCEMENTS)
AssurX helps medical device companies meet tough FDA/regulatory demands. It's critically important to understand and meet the challenges of integrated, global corrective and preventive action (CAPA); complaints management; audits; supplier quality and overall product quality; electronic medical device reporting (eMDR); Learn more here.
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| Government & Regulatory | | |
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- Senators urge device tax implementation delay amid repeal efforts
A group of senators asked Senate Majority Leader Harry Reid, D-Nev., to defer the start of the 2.3% medical device tax as efforts to repeal the levy continue. In a letter, the group urged Reid to support efforts to make sure the U.S. "maintains its global leadership position in the medical technology industry and keeps good jobs here at home." MassDevice.com (Boston)
(12/10)
- 510(k) Submissions Workshop
Monday, Feb. 25 -- Tuesday, Feb. 26
Sheraton Crystal City, Arlington, Va.
This interactive workshop, taught by industry experts and key personnel from the CDRH 510(k) staff, leads participants step by step through the regulatory guidelines, practical steps and strategic considerations for determining a product's regulatory route to market, identifying a predicate device, planning and assembling a 510(k) submission, interacting with the FDA during the review process, and dealing with post-clearance issues. Visit MTLI online for more information.
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| Position Title | Company Name | Location |
| Payer Relations Director | Sonitus Medical Inc | San Mateo, CA |
| Senior Director, Clinical Programs - Transcatheter Heart Valve | Edwards Lifesciences | Irvine, CA |
| Clinical Project Manager | Endologix, Inc. | Irvine, CA |
| Physician Training Program Manager | Endologix, Inc. | Irvine, CA |
| 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 |
| Clinical Director | Stryker | Freemont, CA |
| Senior Director, Quality | American Medical Systems | Minneapolis, MN |
| Strategic Sourcing Manager | Alpha Source, Inc. | Milwaukee, WI |
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| Click here to view more job listings. |
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