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December 10, 2008 News for medical technology professionals   Top Story    Mass. to unveil draft rules on items from drug, device makers Massachusetts' Public Health Council today is set to release draft regulations aimed at restricting the value and kinds of items that drugmakers and device firms may offer to doctors. The proposed rules, however, would not require physicians to disclose research and consulting fees from such companies. Boston Herald (12/10) We address your software needs for quality and compliance. Click here for more InfoMed — Complaint handling and adverse events reporting InfoCAPA — Nonconformance and CAPA InfoAudit — Internal and vendor audits InfoTrain — Employee training InfoSQA — Software development and validation   Business & Market Trends    Given Imaging acquires Medtronic's Bravo system Given Imaging has purchased Medtronic's Bravo pH monitoring system, which is used in the detection of gastroesophageal reflux disease, for $20 million. Given also plans to transfer the production of the device to Israel during the first year after the deal closes. Globes (Israel) (12/9) Lombard Medical postpones recruitment for device trial Lombard Medical Technologies announced that it has halted patient enrollment for a U.S. clinical study of EndoRefix, a graft-fixation device, to reduce expenses. The firm said it is still in talks "with potential investors and expects to update the market on developments in due course." Reuters (12/10) White Paper - 21 CFR Part 820 & ISO 13485 - What's the Difference? The paper describes how the regulations relate and outlines cGMP regulations for manufacturers and importers, covering design, manufacturing, packaging, and servicing of medical devices. Download Now   International Developments  Israeli regulators approve InspireMD's MGuard stent system Israel's Ministry of Health has granted approval to InspireMD for its MGuard coronary stent system. The device features a net that can decrease the risk of restenosis and damage by dispersing pressure on the vessel wall. Pharmaceutical Business Review Online (12/9) More than 90% of SmartBrief clients are repeat advertisers. Results matter and SmartBrief delivers. Learn how we can make your marketing and advertising budget work harder in 2009. Contact a SmartBrief industry expert today.   Science & Health  Study: 3T MRIs can cause irreversible damage to cochlear implants U.S. researchers warned individuals with cochlear implants against using 3T MRI scanners, which can cause permanent damage to the hearing devices. The advanced imaging machines can demagnetize a key part of the implants, according to the study. NYTimes.com (12/8)   Emerging Technologies  Technique allows fusion of prosthetic arm to bone, skin U.K. surgeons used a novel method to merge a metal pin of a prosthetic arm with the skin and bone of a woman who was severely injured during the 2005 London bombings. "We've been able to prove that we can get osteocutaneous integration -- that's to say the soft tissue fuses with the surface of the metal," one of the physicians said. BBC (12/9) PLC Medical Systems gets FDA clearance for device study PLC Medical Systems received FDA approval to begin a U.S. clinical trial aimed at testing the efficacy of its RenalGuard System in preventing contrast-induced nephropathy. The company also secured clearance to boost the number of subjects in the study from 246 to 406 patients. HealthImaging.com (12/9) FDA approves transfusion system from Sunquest Information Systems The FDA has given marketing clearance to Sunquest Information Systems for its Transfusion Management application. The product can be incorporated into the company's blood-bank and laboratory data systems and can be accessed through portable computers. Health Data Management (12/9)   Government & Regulatory  Biotech sector seeks tax break from Congress The Biotechnology Industry Organization and other sector leaders are asking Congress to temporarily amend a tax law to provide cash-strapped life sciences firms with upfront rebates in exchange for forgoing tax deductions that they can get once they become profitable. Bloomberg (12/10), NYTimes.com (12/9) NIH works on disclosure policies for federal grants Criticism from Congress prompted the NIH to work to improve policies that require researchers and universities to disclose federal grants to address conflicts of interest. The agency sought opinions from different sectors and may take six months to a year to formulate regulations, NIH acting Director Raynard Kington said. The Wall Street Journal (free content)/Health Blog (12/8)   AdvaMed News  Webinar -- Electively Accelerating Product Development: Proven Techniques to Reduce Time-to-Market In this Dec. 11 webinar, AdvaMed Associate member MPR will discuss proven techniques that will decrease your company's costs and help you avoid common pitfalls in the product development cycle. These techniques have been applied to both small and large manufacturers. Register now. AdvaMed Emerging Growth Company Council: Our only agenda ... advancing yours. Complaints, MDRs, Reports of Removals and Corrections, and Recalls How do med-tech companies implement and measure the effectiveness of a complaint-handling system covering a diverse set of possible products and problems? How are complaint files managed across multiple domestic and international facilities? When do complaints rise to the level of MDRs, and how do you handle recalls? What are the current FDA enforcement trends in these areas? Through didactic sessions, interactive exercises and discussion of pre-submitted questions, expert industry faculty and FDA speakers will explore these issues in practical terms Jan. 20 and 21, 2009, in Orlando, Fla. Register now. Medical Technology Learning Institute -- Education Beyond a Degree Learn more about AdvaMed -> About AdvaMed  |  Join  |  Courses  |  Events  |  Newsroom 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. 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