Top Story

• Device firms in Tennessee, Georgia oppose device tax
  A provision in the House health reform bill that would impose a $20 billion tax on medical device firms over a decade is drawing criticism from manufacturers and vendors in Tennessee and Georgia because they say the proposal would still result in job cuts and a reduction in research spending. "It's bad news in Georgia and Tennessee, as we're trying to catch up and develop a medical device industry along the lines of some of the other states," said Rick Haury, the Southeastern Medical Device Association's founder. Chattanooga Times Free Press (Tenn.) (11/1)

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Business & Market Trends

• Lake Region contributes to success of Minnesota device industry
  The success of Minnesota's medical device sector has been driven partly by Lake Region Medical, one of the world's largest original equipment makers of medical devices, said David Rhees, an industry historian and Bakken Museum's executive director. The company supplies devices to large device firms such as Medtronic and St. Jude Medical and posts an annual revenue of roughly $169 million. Star Tribune (Minneapolis-St. Paul, Minn.) (10/29)

• Merge Healthcare signs expanded distribution deal with MEDRAD
  Merge Healthcare has signed an expanded distribution agreement authorizing MEDRAD to market its CADstream, a computer-aided detection tool for MRI, in France, the U.K. and other European countries. Merge acquired the product following its purchase of Confirma. American City Business Journals/Milwaukee (10/30)

• TomoTherapy to reduce staff by 10%
  Madison, Wis.-based TomoTherapy, which makes targeted radiation systems for cancer treatment, has plans to reduce its workforce by 10% due to the soft market and economic conditions, according to the company. American City Business Journals/Milwaukee (10/30)

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International Developments

• U.K. unveils draft rules on access to medical technologies
  The U.K.'s Department of Health has released draft regulations that would order health providers to provide sufficient quantities of medical equipment necessary to ensure patient safety. All medical providers are expected to comply with the Health and Social Care Act 2008 (Regulated Activities) Regulations 2009 by 2012. Clinica (subscription required) (10/30)

• EDMA chief to focus on commercialization of diagnostic products
  Jurgen Schulze, the European Diagnostic Manufacturers' Association's newly elected president, said he plans to prioritize the commercialization of new products and the standardization of diagnosis in Europe. "One of our major tasks has been and remains opening up the European markets for new and innovative diagnostic products," Schulze said. Clinica (subscription required) (10/30)

Science & Health

• Survey finds radiologists hesitant to reveal mammography errors
  Radiologists seem reluctant to reveal mammography-related errors and adverse events to patients because of fear of litigation and lack of confidence in their communication skills, among other factors, according to a survey published in the Radiology journal. Although greater openness is necessary regarding errors in breast imaging, the authors concluded that "effective disclosure remains the exception, not the rule." HealthImaging.com (11/2)

• FDA launches Web-based guide about hearing aids
  The FDA has introduced an online guide that provides hearing-impaired patients with information and advice when purchasing and adjusting hearing aids. The agency's guide advises patients to consult their doctors and buy the devices from professionals, among other tips. USA TODAY (11/2)

Featured Content

Hot Topics

Top five news stories selected by AdvaMed SmartBrief readers in the past week.

• Judge dismisses lawsuits against Medtronic over heart device (Reuters)

• Stryker Biotech faces charges alleging off-label marketing of devices (The Boston Globe)

• Senate, House bills may impose lower taxes on device makers (The Wall Street Journal)

• House health bill seeks $20 billion device tax (The Wall Street Journal)

• Becton to acquire molecular diagnostic testing firm (Detroit Free Press)

• Results based on number of times each story was clicked by readers.

Government & Regulatory

• House health care bill would raise costs to the imaging industry
  A health care reform bill unveiled last week by the House of Representatives proposes to increase the presumed equipment-use rate for Medicare reimbursement from 50% to 75% and impose a 2.5% surcharge on the purchase price of new imaging equipment. The changes could cost the medical imaging industry $4.3 billion over 10 years, Access to Medical Imaging Coalition Executive Director Tim Trysla said. Diagnostic Imaging (10/30)

• 2010 Medicare fee schedule increases assumed equipment-use rate
  The CMS on Friday announced that it is increasing the assumed equipment-use rate for medical equipment, including diagnostic imaging systems, from 50% to 90% as part of the new 2010 Medicare fee schedule rules. The agency also said it will require suppliers of advanced imaging services to be accredited by 2012. The new equipment utilization rate for medical imaging systems that cost more than $1 million will be introduced gradually over a four-year period. Diagnostic Imaging (11/2)

AdvaMed News

• Risk Management 201
  This new workshop is designed for people familiar with risk assessment and risk management principles, who seek practical guidance on implementation in medical technology firms. It will enhance understanding of regulatory expectations and of workable methods to meet them. Lectures, breakout exercises of simulated industrial challenges, panel discussions, and networking opportunities will help participants make product decisions with risk management data and establish related policies and procedures. 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 Risk Management; 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.

Editor's Note

• Do you expect the economy to negatively affect your company in 2010?
  Look out for the AdvaMed SmartBrief Year-End Report on Dec. 8 and 15. The results of this poll will appear in Part 2 on Dec. 15.

	Yes.
	Maybe.
	No.

Product Manager, Laparoscopy Gyrus ACMI Southborough, MA Senior Quality Assurance Engineer Covidien Boulder, CO Senior Software Quality Engineer Covidien Carlsbad, CA Director of Marketing- General Surgery Gyrus ACMI Southborough, MA Director Regulatory Affairs Abbott Medical Optics Santa Ana, CA Sr. Engineering Manager -Laser Systems Abbott Medical Optics Milpitas CA Biologist - Biocompatibility Analyst W.L. Gore & Associates, Inc. Flagstaff, AZ

SmartQuote

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