| March 12, 2013 | News for medical technology professionals |
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- Invendo gets FDA OK for single-use colonoscopy device
Invendo medical has received 510(k) clearance from the FDA for its C20 colonoscopy device along with the company's SC20 colonoscope, a handheld tool designed to be used with computer-aided technology that will minimize stress on the colon wall. The devices have been installed for the first time in the U.S. at two facilities in New York. BeckersASC.com
(3/11)
 | Document Control Made Easy
BSI's web-based solution significantly reduces the cost and effort needed to effectively manage documents, performance, and sustainability activities within your quality management system. It gives transparency and control across your entire organization. To learn more, download case studies.
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Some of the best and brightest business and scientific minds will gather for Plastics News' Plastics in Medical Devices conference, May 13-15 in Boston. A strong program features Becton Dickinson, Boston Scientific, Covidien, Edward Lifesciences, MassMEDIC, Philips Respironics, Phillips-Medisize Corp., UMass Lowell and Ximedica, among others. See the full agenda and register.
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- St. Jude releases device to promote personalized stenting
A next-generation device intended to help doctors tailor stenting decisions to the individual patient's anatomy and disease state has been released by St. Jude Medical. The company said the Ilumien Optis System is the only such device that combines fractional flow reserve and intravascular optical coherence tomography imaging into a single unit. RTT News
(3/11)
- New MRI scanner from Philips allows imaging of more patients
Philips has introduced the Multiva 1.5T MRI scanner for use in diffusion tensor imaging, magnetic resonance spectroscopy and related procedures. The device, unveiled at a cardiology meeting, includes the firm's FlexStream workflow and is designed to reduce pre-scan setup time by up to 40%, which will allow imaging of more patients. MedGadget.com
(3/11)
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- Molecular Diagnostics
Wednesday, June 5 – Thursday, June 6 Sheraton Crystal City, Arlington, Va. In this meeting, FDA and industry speakers will address current regulatory, reimbursement and legislative topics in the evolving field of molecular diagnostics in an interactive two-day program. Attendees will participate in sessions ranging from the latest government policies aimed at molecular diagnostics, health care reform and implications for diagnostics; FDA oversight and regulation of molecular diagnostics; key regulatory considerations in developing molecular diagnostics and what it takes to make to create a good submission; developments impacting personalized medicine; co-development and the future of companion diagnostics; the changing landscape of molecular diagnostics reimbursement; and an afternoon on future proposals that could foster the introduction of new molecular diagnostics. 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 |
| Project Manager, Regulatory Affairs - Transfusion Medicine | Johnson & Johnson | Raritan, NJ |
| Associate Counsel | ACell, Inc. | Columbia, MD |
| 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 |
| Manager, HCL Regulatory & Quality Compliance | Owens & Minor | Louisville, KY |
| DIR OPERATIONS, Milpitas Site - 130000007R | Abbott | San Jose, CA |
| Biostatistician - Post Market Surveillance | Johnson & Johnson | Raynham, MA |
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 | We are all worms. But I do believe that I am a glow-worm."
--Winston Churchill, British prime minister

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