| March 20, 2013 | News for medical technology professionals |
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- Bipartisan support key in repealing device tax
Medical-device companies are educating key Democrats to build support to repeal the 2.3% medical device tax that took effect in January. Events organized by trade groups such as AdvaMed, as well as company tours and a letter circulated among Senate Democrats last year, have helped the cause gain bipartisan support. Minnesota's senators have been talking with President Barack Obama to soften his stance as well. "I think that there has been some renewed understanding on the president's part," said Sen. Al Franken, D-Minn. The New York Times (tiered subscription model)
(3/19)      
 | CAPA Violations Still the Top Issue for FDA:
FDA inspectors view a firm's CAPA program as an indicator of how well or how poorly a firm has a handle on its overall operations.
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| 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. |
- Welsh government opens $159M fund for life sciences firms
The Welsh government has announced the launch of the Wales Life Sciences Investment Fund, which aims to promote job and business growth as well as boost the global profile of the biotech sector in that country. The fund, worth $159 million, is expected to help launch more Welsh medical device and diagnostic companies in the U.K. and international markets. Clinica (subscription required)
(3/19)
| Science & Health | | |
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- Engineer uses 3D printing technology to improve prostheses
3D printing will transform the medical device industry by enabling users to produce more comfortable prostheses, according to product development engineer Bilal Ghalib. His organization, the Global Entrepreneurship and Maker Space Initiative, seeks to bring such new technologies to the developing world. Ghalib created a better-fitting prosthetic leg for his cousin using 3-D printing. USA Today
(3/17)
| Emerging Technologies | | |
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- Dune Medical's breast cancer device debuts in U.S.
Dune Medical Devices has announced the U.S. release of its MarginProbe System, which was approved by the FDA in January. The University of California, Irvine Medical Center was the first in the U.S. to deploy the system, which is used for tissue evaluation during early-stage breast cancer procedures. Boston Herald
(3/19)
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| Government & Regulatory | | |
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- NuVasive gets warning letter over spinal implant marketing
The FDA has issued a warning letter to NuVasive over certain marketing language regarding the company's Affix Spinous Process Plate System. NuVasive said in a regulatory filing that it is already beginning to address the issue, and the company stressed to its shareholders that there were no manufacturing problems that needed to be addressed. MassDevice.com (Boston)
(3/19)
- 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.
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| Position Title | Company Name | Location |
| Sales / Technical Specialist | Kaneka Pharma America LLC | New York, NY |
| Sales Area Manager/Sales Rep of Neurovascular Intervention Products | Asahi Intecc USA, Inc. | Any location in US, CA |
| Sr.Regulatory Affaris Associate | Mindray DS USA, Inc. | Mahwah, NJ |
| Project Manager, Regulatory Affairs - Transfusion Medicine | Johnson & Johnson | Raritan, NJ |
| Associate Counsel | ACell, Inc. | Columbia, MD |
| Compliance Consultant 2 | DJO Global | Vista, CA |
| Director, Health Care Compliance | RTI Biologics | Alachua, FL |
| Accreditation Manager | American Association of Tissue Banks | McLean, VA |
| REGULATORY AFFAIRS SPECIALIST | Masimo Corporation | Irvine, CA |
| Manager, HCL Regulatory & Quality Compliance | Owens & Minor | Louisville, KY |
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| Click here to view more job listings. |
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| SmartQuote | | |
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 | Quality is not an act, it is a habit."
--Aristotle,
Greek philosopher
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| | Recent AdvaMed SmartBrief Issues:
- Tuesday, March 19, 2013
- Monday, March 18, 2013
- Friday, March 15, 2013
- Thursday, March 14, 2013
- Wednesday, March 13, 2013
| | | Lead Editor: Lisa Gough
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Topera Medical has obtained $25 million in a round of financing from unnamed backers. The San Diego startup is the maker of the FDA-cleared RhythmView 3D mapping device, which is used to deliver targeted therapy to the heart's electrical "hot spots" in patients with cardiac rhythm disorders. 
