| November 3, 2009 | News for medical technology professionals |
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- AdvaMed commends China's measures to streamline regulatory process
China's health ministry and the State Food and Drug Administration will retain responsibilities regarding recalls of medical devices in an effort to prevent redundancies in recall regulations. The move is one of the measures for streamlining the regulatory process for devices announced by the Chinese government at a meeting of the U.S.-China Joint Commission on Commerce and Trade in Hangzhou, China. Clinica (subscription required)
(11/2)
      
| Business & Market Trends |  | |
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- FDA says Zimmer's spinal implant meets study goal
FDA reviewers said Zimmer Holdings' Dynesys implant is as effective as the company's Silhouette implant in treating spinal problems, but raised questions about possible influence on the study. A company spokesman did not immediately comment on the issue. An FDA panel is set to meet Wednesday to discuss the product. Google/The Associated Press
(11/2)
- Hospitals raise concerns over confidentiality of device prices
Some hospitals find it hard to negotiate prices for medical technologies because device firms sometimes require confidentiality requirements that prevent hospitals from disclosing the prices of products to companies that sell data to help analyze market conditions. The device sector recognizes its confidentiality practices, saying price disclosure could result in higher prices and might lead to collusion. "The evidence is strong that the competitive forces in our industry work extremely well," AdvaMed Senior Executive Vice President David Nexon said. The Wall Street Journal/Dow Jones Newswires
(11/2)
- Doctor cites hospital execs' financial ties with device firm in lawsuit
David Gossman, an interventional cardiologist formerly with Lahey Clinic hospitals in Boston, has filed a lawsuit claiming that he was dismissed after complaining about the financial ties of hospital executives with Medtronic. Gossman also claims that the officials pushed other physicians to use more products from the company. A spokesman for Medtronic said he wasn't able to verify the link between the firm and hospital officials and noted that the company's code of conduct would not permit such a behavior by the executives. The Wall Street Journal/Health Blog
(11/2)
| International Developments | | |
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 | Former FDA staff and industry experts discuss important regulatory and practical issues at AdvaMed MTLI's annual workshop on Combination Products. November 16 – 17, Washington, DC. Find details and get your $250 discount here. |
| Government & Regulatory | | |
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- House GOPs criticize "federal bureaucracies" in health proposal
Republicans in the House of Representatives warned that the Democrats' health reform proposal would create 111 new federal bureaucracies, programs and boards, citing a health insurance exchange, an FDA women's health unit and a CMS center for innovation, among others. A Democratic source said the "bureaucracies" are only new "programs and demonstration projects" that would be used to "test new policies before more broadly implementing them." FoxNews.com
(11/2)
 | See how Pilgrim Software used an unconventional marketing strategy to build market share in the life science and biotechnology industry and achieve Fortune 500 results at a fraction of the cost. Download this Life Science case study (free for SmartBrief subscribers). |
| AdvaMed News | | |
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Advertising and Promotion of Medical Devices
What are the regulatory and legal guidelines for appropriate advertising and promotion of medical technologies? How and when are companies permitted to disseminate off-label information or to respond to physician requests? Legal experts, company compliance officers and representatives from the FDA offer guidance in these and other areas. More information. Medical Technology Learning Institute -- Education Beyond a Degree
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Sign up now for $250 discount
AdvaMed's MTLI is offering a $250 discount on all remaining 2009 courses. Courses include Advertising and Promotion; MDRs; Clinical Trials; and Combination Products. Full agendas and logistical information can be obtained on our Web site. In order to receive your discount, please contact Katia Kunze at (202) 434-7237. Some restrictions apply.
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