Reading this on a mobile device? Try our optimized mobile version here: http://r.smartbrief.com/resp/nUzshMrCCCaYylLqjT

December 17, 2008 News for medical technology professionals   Top Story    Calif. simulation center helps physicians boost surgical competency The California Pacific Medical Center runs a simulation facility that uses robots and other technologies to allow veteran physicians to learn new surgical methods or improve their skills. The simulation center, which opened in October, could also assist in training medical practitioners around the globe, facility director Stephen Lockhart said. The Washington Post (12/16) 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    PSivida gets funding to test drug deliverer for new use A "global medical device company" offered to finance a study on pSivida's drug-delivery technology to find out whether it can be used for cardiovascular conditions. The biotech firm in Massachusetts is conducting late-stage trials of the injectable device, which administers anti-swelling drugs into the eyes for as long as three years. American City Business Journals/Boston (12/16) Endoscopic Technologies raises $11.2M in funding, picks new executives Endoscopic Technologies said it has secured $11.2 million in financing from Saints Capital Everest and other investors. The surgical-device firm also announced personnel changes, including the appointment of John Pavlidis as president and CEO as well as Terry Kinninger as chief financial officer and chief operating officer. American City Business Journals/San Francisco (12/16)   Feeling the Pinch in Today's Difficult Credit Market? Increasing credit costs can ripple through your business to affect longer-term plans that are essential to growth. Download the CFO Research Services report produced in collaboration with American Express: No Stone Unturned: Strategies for Cash Management in Hard Times to gain insight on how midsize companies are adapting in order to maintain their competitive positions under tough circumstances.     International Developments  Philips buys businesses to boost presence in home-based health care Royal Philips Electronics has purchased businesses and other assets to allow for the expansion of its home-based health care division. The acquisitions include the aerosol-therapy unit of Italian firm Medel as well as a production plant for nebulizer compressor operations and systems located in Guangdong, China. HealthImaging.com (12/15) Looking for senior industry decision-makers? SmartBrief's got them. More than 62% of our subscribers hold director, VP or C-level titles. Our subscribers are your prospective customers. Speak with SmartBrief to get better, measurable results for each advertising dollar   Science & Health  Study: FDG-PET/CT can be used in staging Hodgkin's disease U.K. researchers found that FDG-PET/CT exhibited high sensitivity and specificity in detecting focal bony disease in people with Hodgkin's disease. The findings indicate that FDG-PET/CT should be used in the initial staging of the disease and that bone marrow trephine biopsy should be used "far more judiciously," the scientists said. AuntMinnie.com (free registration) (12/19) Scientists: Genetic method better at predicting breast cancer spread An approach that focuses on the subnetworks of tumors' genetic activity works better than traditional "rapid microarray" technology in gauging the metastasis of breast cancer, U.S. and Korean scientists reported. They said the technology could serve as a diagnostic and prognostic tool for other cancers as well. U.S. News & World Report/HealthDay News (12/16) The Buzz(CORPORATE ANNOUNCEMENTS) FREE White Paper: "So You Have an Outcome Registry, Now What? Practical Tips to Registry Administration" Robust risk management strategies include outcome registries used to collect safety, efficacy, clinical benefit, and QOL information. Independence of the data and regulatory scrutiny should be considered. This white paper provides tips for administration of a registry. Interested in learning more about advertising in AdvaMed SmartBrief? Contact Meryl Harold at (202) 407-7828 or mharold@smartbrief.com.     Emerging Technologies  Imaging device could help breast cancer patients avoid more surgeries U.S. experts are developing an imaging device that can help doctors distinguish between cancerous breast tissues and normal ones. Tests show that the experimental device has an 85% sensitivity in identifying tissues that should be removed, one of the researchers said. The device may help save breast cancer patients from undergoing more than one surgery, the scientists said. ABC News (12/15) Surgical tool helps doctors transplant stem cells into the brain Canadian scientists have developed a surgical device that can assist in safely transplanting stem cells into specific brain areas of people with neurological diseases. The Halifax Injector is attached to a computer that allows doctors to program various functions of the device, including delivering the correct amount of stem cells into the brain. The Chronicle-Herald (Halifax, Nova Scotia) (12/15) Australian scientists to develop "hi-fi" ear Graeme Clark, an Australian expert who pioneered the multichannel bionic ear, has presented a preliminary prototype of next-generation electrode fibers designed to trigger hearing. Clark is set to head a team of specialists who will work over the next few years to develop a high-fidelity ear at La Trobe University in Australia. The Age (Melbourne, Australia) (12/17)   AdvaMed News  PMA Submissions Workshop Completing the MTLI set of interactive submissions workshops, Feb. 26 and 27 in Las Vegas, senior industry experts and members of the CDRH device evaluation and bioresearch monitoring staffs lead participants through the strategic considerations and practical steps of filing a PMA, illustrated with real-world case studies. Topics include strategy development and evidence requirements, productive meetings with FDA, the mechanics of submission development, advisory panels, inspectional activity, conditions of approval studies and the care and feeding of approved PMAs. Sign up for the workshop. Medical Technology Learning Institute -- Education Beyond a Degree Validation of Non-product Software: Assuring Compliance and Improving Quality During this seminar, Jan. 22, 2009, in Orlando, Fla., you'll learn from FDA and industry leaders: How to use TIR 36 to define validation practices for non-product software. FDA's compliance observations regarding software validation and Part 11. How industry leaders are using ITIL to tailor software validation processes. You'll also get custom checklists for Part 11 and TIR 36 as well as a sample software validation procedure. 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   SmartQuote  Fighting about issues [from] 25 years ago robs our children of resources, which are already scarce." --Arne Duncan, President-elect Barack Obama's pick for Education Department secretary     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: Tuesday, December 16, 2008 Monday, December 15, 2008 Friday, December 12, 2008 Thursday, December 11, 2008 Wednesday, December 10, 2008     Lead Editor:  Ashley McMaster       Mailing Address: SmartBrief, Inc.®, 1100 H ST NW, Suite 1000, Washington, DC 20005     © 1999-2011 SmartBrief, Inc.® Legal Information