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December 12, 2008 News for medical technology professionals   Top Story    Minn. bill would require disclosure of device firms' ties with doctors Minnesota state Sen. John Marty was scheduled Thursday to conduct a hearing on legislation aimed at requiring device makers to report gifts and payments to doctors in the state. The bill would expand a 1993 state law on disclosure requirements. An official with AdvaMed, which supports a federal law, said different state rules "will likely confuse the public and create unnecessarily burdensome and costly requirements for companies that offer medical treatments" across the U.S. Star Tribune (Minneapolis-St. Paul, Minn.) (12/11)   Analyst Report – Risk Management: Best Practices for Medical Device Profitability Does a device manufacturer's approach to risk make them more likely to outperform their peers? This report assesses how risk management is employed within device companies and identifies best practices. Read the report: www.camstar.com/riskmanagement.html     Business & Market Trends  GE Healthcare plans to reduce staff GE Healthcare is looking to slash costs by laying off workers across its business divisions and facilities, said Brian McKaig, a company spokesman. The plan is aimed at improving the firm's performance and bolstering its chances "for profitable long-term growth," McKaig said. American City Business Journals/Milwaukee (12/12) Semprus gets $8M in financing round Semprus BioSciences has secured $8 million from 5AM Ventures and other private investors that joined a round of Series A funding. Semprus said it will use the money to further develop its antibacterial-coatings technology, including one that offers a stable surface structure for medical devices to lower risk of complications. Mass High Tech (Boston) (12/11) Cook Medical to build manufacturing facility in Illinois Cook Medical has unveiled plans to construct a 45,000-square-foot production plant at a former International Harvester site in Canton, Ill. The proposed facility, which is expected to be finished by next fall, could generate more than 300 jobs over the next few years. Peoria Journal Star (Ill.) (12/11) Medtronic investors file suit over Infuse device Shareholders have filed a lawsuit against Medtronic in federal court in St. Paul, Minn., alleging that the company misrepresented the profitability of its Infuse bone graft. The suit argues that sales of the product relied more on its off-label use rather than applications reported to investors. A Medtronic spokeswoman declined to comment regarding the pending legislation. Finance and Commerce (Minneapolis)/Bloomberg (12/11), Star Tribune (Minneapolis-St. Paul, Minn.) (12/11)   Science & Health  Study finds problems linked to multiple replacements of defibrillators A Canadian study found that people with implantable cardioverter defibrillators who have undergone several pocket procedures are more likely to experience complications after ICD replacement. The finding could shed more light on the factors that increase the risks associated with ICD replacement, one of the researchers said. Yahoo!/HealthDay News (12/11) Study: Cord blood can supply stem cells for transplants A U.S. study found that cord blood cells are a suitable alternative to bone marrow or peripheral blood progenitor cells for acute leukemia patients who need a stem cell transplant. The research showed that cord blood transplants have longer engraftment time and greater mortality but less later morbidity compared with other stem cell sources. MedPage Today (free registration) (12/11) SmartBrief Content + Association Context = Advertiser ROI SmartBrief combines must-read industry content, co-branded with leading trade associations who serve your target customers. SmartBrief delivers best-in-class click-throughs and open-rates. 90% of SmartBrief clients are repeat advertisers. Contact a SmartBrief industry expert today.   Emerging Technologies  Axial Biotech unveils DNA-based test for scoliosis Axial Biotech has introduced ScoliScore, a genetic test designed to assess the risk of severe curve progression in children with adolescent idiopathic scoliosis. The company plans to commercially distribute the product in 2009 through a deal with DePuy Spine. Pharmaceutical Business Review Online (12/10)   Government & Regulatory  2 health crusaders are seen as top candidates to lead FDA Dr. Joshua Sharfstein, Baltimore's health commissioner, and Dr. Steven Nissen, the Cleveland Clinic's head of cardiovascular medicine, are reportedly leading the list of contenders for the next Food and Drug Administration commissioner. Drugmakers expressed concern over the possible appointment of either candidate, citing Sharfstein's and Nissen's efforts to persuade the agency to take a tougher stance on safety issues. The Wall Street Journal (tiered subscription model) (12/12) Obama names Daschle chief of HHS, Office of Health Reform President-elect Barack Obama announced that he chose former Senate Majority Leader Tom Daschle as HHS secretary and head of the new White House Office of Health Reform. Daschle said he plans to make changes to the U.S. health care system from the "grass roots up" if his appointment is confirmed. The Wall Street Journal (tiered subscription model)/The Associated Press (12/12), USA TODAY (12/12)   AdvaMed News  Medical Technology Reimbursement Specialist workshop Join us for this intensive program, Feb. 17 to 20, 2009, in Las Vegas, where leading experts in the field lead participants through didactic sessions, case studies and working hypothetical exercises. This comprehensive workshop is designed for beginning and seasoned reimbursement professionals, as well as sales and marketing, product managing, strategic planning and all others who might benefit from a working understanding of reimbursement and its relationship to company business objectives and product strategies. Register for this event. Medical Technology Learning Institute -- Education Beyond a Degree Risk-Based Strategies for Design Control and Software Validation During this seminar, Jan. 21 in Orlando, Fla., you'll learn from FDA and industry leaders: How Ethicon-Surgery has integrated product innovation into its design processes How to implement a risk-based design-control process based on IEC 62304:2006 The most common 483 observations for design control and software validation You'll also get guidelines and checklists for code, design description, requirements specification and test review. Get more information. Medical Technology Learning Institute -- Education Beyond a Degree Learn more about AdvaMed -> About AdvaMed  |  Join  |  Courses  |  Events  |  Newsroom Senior Regulatory Manager BIOTRONIK, Inc. Portland, Oregon Director of Marketing Heart Rhythm Society Washington DC Manager, Practice Management and Reimbursement Heart Rhythm Society Washington DC Associate Director QA/RA ATEX Technologies, Inc. Pinebluff, North Carolina Sr. Product Marketing Manager Edwards Lifesciences Irvine, California   SmartQuote  Right or wrong, the customer is always right." --Marshall Field, department store developer     Subscriber Tools       Print friendly format | Web version | Search past news | Archive | Privacy policy Advertise Account Executive:  Meryl Harold (202) 407-7828 Download Media Kit Job Board:  Celia Rothschild (202) 470-1159   Read more at SmartBrief.com A powerful website for SmartBrief readers including: Industry Home Readers' Choice Search Archive Who's Hiring? Grab our News Widget Get this RSS Feed Publish your Press Release       Recent AdvaMed SmartBrief Issues: Thursday, December 11, 2008 Wednesday, December 10, 2008 Tuesday, December 09, 2008 Monday, December 08, 2008 Friday, December 05, 2008     Lead Editor:  Ashley McMaster       Mailing Address: SmartBrief, Inc.®, 1100 H ST NW, Suite 1000, Washington, DC 20005     © 1999-2011 SmartBrief, Inc.® Legal Information