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November 5, 2009 News for medical technology professionals     Top Story    Firms need plan, commitment in branching out into device sector Manufacturing firms seeking to diversify into the medical-device industry must come up with a detailed plan and make a long-term commitment, panelists said at the fifth annual MichBio Expo. Mark Symonds, Plex Systems' president and CEO, offered companies some tips for breaking into the device sector, such as evaluating the strengths of the firm and assessing potential markets and trends. Business Review Western Michigan (11/4) , Crain's Detroit Business (free registration) (11/4) Medmarc announces "Attorney of the Year" at annual medical device seminar and defense counsel meeting. Learn more about our winner — James Conkright of Haden, Cowherd & Bullock, LLC. medmarc.com      biomedic-insure.com      thehartford.com     Business & Market Trends    AtriCure tentatively settles whistle-blower suit with Justice Department AtriCure has agreed to pay $3.8 million over five years to settle allegations that it violated the False Claims Act regarding the marketing of its medical products. The tentative settlement "will allow us to focus on the business and executing our strategic priorities, including restoration of growth trends and increased shareholder value," said President and CEO David Drachman. AtriCure has denied any wrongdoing in the agreement. American City Business Journals/Cincinnati (11/4) Synthes issues recall over spinal implants Synthes voluntarily recalled Synex II Central Body components after it received six reports of adverse events, a move classified by the FDA as a Class I recall. The company has told surgeons and hospitals to stop using the spinal implants immediately. Reuters (11/4) , The Philadelphia Inquirer (11/4) Zimmer fails to get FDA panel's support for Dynesys implant An FDA panel voted against recommending Zimmer Holdings' Dynesys implant because studies failed to clearly demonstrate the safety and efficacy of the device in treating a spinal problem. A company official said Zimmer's data "demonstrated a reasonable assurance of safety and effectiveness" of the titanium implant. The Times-Picayune (New Orleans)/The Associated Press (11/4) Take the 2nd Annual Medical Device/IVD Industry Survey Find out what your colleagues are saying about prospects for the industry in 2010. Do companies plan to expand? What are the hot international markets? Will companies be hiring in 2010? Complete this quick 2 minute survey and receive a PDF copy of the full survey results in mid November. Take the survey now.   International Developments  China approves three devices from AGA Medical The Chinese government has granted approval to heart device firm AGA Medical for its three devices: AMPLATZER PFO Occluder, AMPLATZER Multi-Fenestrated Septal Occluder "Cribriform" and AMPLATZER Vascular Plug II. Abbott Laboratories will distribute the products in China. MedCity News (Cleveland) (11/4) Vysera licenses medical technologies to Merit Medical Systems Vysera Biomedical has agreed to exclusively license valve and biomaterial technologies to Merit Medical Systems. "We believe the licensed technologies will be beneficial for products developed for Merit's Endotek division as well as our interventional radiology product group," said Merit Chairman, President and CEO Fred P. Lampropoulos. Galway Advertiser (Ireland) (11/5)   Science & Health  Study backs safety of on-pump bypass surgery U.S. doctors found that coronary bypass surgery that uses a heart-lung pump proved more effective than off-pump surgery in reducing risks of death, heart attack or further cardiac operations. However, the study showed no differences between off-pump and on-pump procedures in length of stay, neurological outcomes and function of other organs, one of the researchers said. Reuters (11/4)   Emerging Technologies    FDA clears devices from Optima, Quick-Med The FDA has granted clearance to Optima Neuroscience for its IdentEvent device used for detecting seizures. The agency also cleared Quick-Med Technologies' Nimbus barrier gauze wound dressing, which received Class II device classification. The Gainesville Sun (Fla.) (11/4) Download this free white paper on Governance, Risk and Compliance: Complying with regulations and managing penalties for failing to operate within the rules requires both money and time. Organizations that can master the procedures and tasks that bear upon compliance operate more efficiently, compete more effectively and build their brands and good names in the marketplace.   Featured Content    The Benefits of Outsourcing Your Billing Michelle V. Rafter Network-Attached Storage Is the New "Multifunction Printer" for SMBs Jon Stokes from Ars Technica Proper Credit Policies & Procedures Can Help Minimize Your Cash Flow Denise O'Berry 6 Desktop Apps for Better Organization & Focus Behance Team Five Keys to Sales When You Hate to Sell? Susan L. Reid   Government & Regulatory    Value of registries for medical devices debated Eugene Schneller, an Arizona State University business professor, tells The New York Times that in his view more data to compare the benefits of competing makers' products or their prices would be useful as physicians choose the surgical implants they use in caring for patients. The New York Times (11/4) Cancer care better in the U.S. than in other countries The current health care system in the U.S. has helped improve cancer treatment and contributed to higher rates of survival compared with other countries, writes Diana Furchtgott-Roth, former chief economist at the Department of Labor. According to a study cited by Furchtgott-Roth, diagnostic imaging procedures, drugs and physician quality in all 50 states "almost always had positive and statistically significant effects on life expectancy." Forbes (11/5) 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.   AdvaMed News  Combination Products Key present and former FDA staff and industry experts discuss important regulatory and practical issues related to combination products, including the new proposed rules on GMPs and postmarket safety reporting for combination products. More information. Medical Technology Learning Institute -- Education Beyond a Degree Sign up now for $250 discount AdvaMed's MTLI is offering a $250 discount on all remaining 2009 courses. Courses include 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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