| December 16, 2008 | News for medical technology professionals |
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 | Leveraging the Benefits of eMDR: A Guide to Taking Advantage of eMDR (electronic medical device reporting) to Improve your Operations – Learn how eMDR works, what the FDA says about it, and benefits of adopting the technology through developing an effective strategy now. Request your copy here |
| Business & Market Trends |  |  |
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- AtriCure shareholders file suit over financial statements
Investors have filed a class-action case against AtriCure in federal court in Cincinnati, alleging that the company falsified financial statements submitted to the Securities and Exchange Commission. The lawsuit comes after the Justice Department began examining whether the firm used unlawful methods to promote its surgical-ablation devices, which have not received FDA approval. AtriCure said it will "vigorously defend" itself against the suit. The Western Star (Lebanon, Ohio)
(12/15)      
- SEC filing: TransMedics drops plans to go public
TransMedics has called off a plan for an initial public offering because of unfavorable market conditions, according to a filing with the Securities and Exchange Commission. The startup firm hoped to secure $86.3 million from the IPO to develop and commercialize its Organ Care System, a product designed to maintain the freshness of organs intended for transplantation. Mass High Tech (Boston)
(12/15)
| Science & Health | | |
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- Study: Colonoscopy less accurate than previously thought
A Canadian study found that colonoscopies failed to spot almost every cancer in the right side of the colon and missed approximately one-third of tumors in the left side. Screening experts suggest that patients should continue to undergo the procedure because it remains an effective preventive measure, but they should look for more experienced colonoscopists. NYTimes.com
(12/15)
- Study links self-referrals to increase in nuclear MPI use
A U.S. study found that the use of nuclear myocardial perfusion imaging among cardiologists increased by 159% between 1998 and 2006. The finding suggests that the surge is likely driven by self-referrals because "there is no evidence for increase in incidence of coronary artery disease," said Dr. David Levin, who presented the study. Such practice should be avoided to ensure that imaging costs are not unnecessarily inflated, Levin said. AuntMinnie.com (free registration)
(12/15)
| Emerging Technologies | | |
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| Government & Regulatory | | |
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- FDA chief to step down on Inauguration Day
FDA Commissioner Dr. Andrew von Eschenbach notified agency officials that he intends to leave his post Jan. 20. In the internal memo, von Eschenbach said he will cooperate with President-elect Barack Obama's transition group "to ensure a seamless change in political leadership at the agency." The Wall Street Journal
(12/15)
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Massachusetts Code of Medical Device Manufacturer Conduct
Massachusetts is preparing regulations to implement a first-of-its-kind drug and medical-device marketing law requiring firms to abide by a state-developed code of conduct and to report payments to health care providers. Every device firm needs to understand the implications of this law, which will significantly affect activities in Massachusetts and may be copied in other states and at the federal level. Join us Jan. 7, 2009, from 2 to 3:30 p.m. EST as experts intimately familiar with the Massachusetts law and evolving thoughts on its implementation and company best practices share their knowledge and experience. Learn what will and will not be permitted under the law, the implementation timetable and the status of marketing restrictions in other states and at the federal level. Register now. Medical Technology Learning Institute -- Education Beyond a Degree
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Investigational Device Exemption Submission workshop
MTLI offers this one-day interactive workshop on Feb. 25, 2009, in Las Vegas, to lead attendees through the regulatory and practical guidelines governing when an IDE is required, how to compile an effective IDE application, the rules governing clinical studies and human subject protection, Institutional Review Boards, types of pre-IDE meetings and communications, early/expanded access, foreign studies and export, and reimbursement for investigational devices. Register now. Medical Technology Learning Institute -- Education Beyond a Degree
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