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December 4, 2012News for medical technology professionals

  Top Story 
 Free On-Demand Webinar: Pilgrim Training Management Product Showcase
Processes, regulations and documentation changes drive constant challenges in employee training and knowledge management. Discover how to increase organizational control and enforce SOPs through automated document and training management. DOWNLOAD THIS FREE WEBINAR NOW.

  Business & Market Trends 
  • Medtech giants win supply contracts from hospital GPO
    St. Jude Medical, Medtronic, Boston Scientific and several other leading medical device makers have each struck a supply deal with Novation. The deals call for the companies to provide the hospital group purchasing organization with cardiovascular systems, including those used in cardiac rhythm management and vascular closure. (Boston) (11/30) LinkedInFacebookTwitterEmail this Story
ISO 13485 - Change? Do I Have To??
This white paper reviews the conundrum companies are experiencing if they want to maintain both ISO 9001 and ISO 13485 certification: How to comply with the varied requirements within only one quality system. The paper discusses the changes in ISO 13485, what and who the changes affect, and how companies can prepare for a more successful transition to the new standard. Download the whitepaper.
  International Developments 
  • EU regulators approve BioVentrix's heart failure device
    BioVentrix has earned CE mark approval to market its Revivent Myocardial Anchoring System in Europe. The device, which is used to promote functional improvement of the heart's left ventricle in patients with congestive heart failure, is designed to provide a less invasive alternative to surgical ventricular restoration. (12/3) LinkedInFacebookTwitterEmail this Story
  Science & Health 
  • PET, MRI yield clues on pain experience in fibromyalgia
    Researchers using functional MRI and PET with [11C]carfentanil found that in women with fibromyalgia who were opioid-naive, "changes in functional imaging outcomes were negatively associated with changes in clinical pain." The findings suggest that fibromyalgia pain may be resulting from endogenous opioid-induced hyperalgesia and that patients who manifest changes in the opioid receptor system may have a lower chance of responding to classical exogenous opioids such as codeine and morphine, according to researchers, who reported their findings at a rheumatology meeting. Healio (12/3) LinkedInFacebookTwitterEmail this Story
  Emerging Technologies 
  • Ivera's tool to disinfect IV device tips gets FDA OK
    The FDA has given Ivera Medical 510(k) clearance to market its line of disinfection tools called Curos Tips. The technology is intended to offer clinicians an affordable and safer means of disinfecting male luer connectors on devices used to administer intravenous drugs. (12/3) LinkedInFacebookTwitterEmail this Story
  Industry Service Providers 
  • Toshiba hits a milestone for advanced MRI scanner
    Fairview Southdale Hospital in Minnesota has deployed Toshiba America Medical Systems' Vantage Titan technology, the company's first installation of the 16-channel MRI scanner. The 1.5-tesla system, which will be used for general MRI, heart and breast scanning, will also allow the hospital to add prostate imaging to its patient services. (free registration) (12/3) LinkedInFacebookTwitterEmail this Story
  Government & Regulatory 
  • FDA creates collaborative partnership with medical device makers
    The FDA and medical device makers formed a nonprofit organization, the Medical Device Innovation Consortium, to work with one another and with patient advocacy groups, CMS, foundations and academia to speed device approvals while protecting patients. "I know there will be real advances and new approaches that will emerge from it," said FDA Commissioner Dr. Margaret Hamburg. Medtronic, Boston Scientific, Becton Dickinson, Abiomed and Cyberonics are among the medical device companies participating in the consortium. Reuters (12/3) LinkedInFacebookTwitterEmail this Story

AssurX helps medical device companies meet tough FDA/regulatory demands. It's critically important to understand and meet the challenges of integrated, global corrective and preventive action (CAPA); complaints management; audits; supplier quality and overall product quality; electronic medical device reporting (eMDR); Learn more here.

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AdvaMed News 
  • Premarket Approval (PMA) Submissions Workshop
    Thursday, Feb. 28 – Friday, March 1
    Sheraton Crystal City, Arlington, Va.
    Completing the MTLI set of interactive submissions workshops, 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 the FDA, the mechanics of submission development, advisory panels, inspectional activity, conditions of approval studies, and the care and feeding of approved PMAs. Visit MTLI online for more information. LinkedInFacebookTwitterEmail this Story
  • Join the AdvaMed-MTLI LinkedIn group!
    Build close relationships with member companies, both small and large, and receive an intimate understanding of the key issues affecting innovation, access and the bottom line. Interact in discussions that leverage the leadership and expertise of the medical technology industry. This social group is full of key stakeholders, influencers and industry thought leaders as well as regulatory and policy experts from the FDA and CMS. Aside from practical learning opportunities, this LinkedIn group provides the premier opportunity to network with key players from virtually every aspect of the industry. Link to the AdvaMed MTLI LinkedIn group page. LinkedInFacebookTwitterEmail this Story
Learn more about AdvaMed ->About AdvaMed | Join | Courses | Events | Newsroom

Position TitleCompany NameLocation
Payer Relations DirectorSonitus Medical IncSan Mateo, CA
Clinical DirectorStrykerFreemont, CA
Clinical Education Manager, Vascular TherapiesCovidienMansfield, MA
Manager, Grassroots and Member Engagement, Government Affairs AdvaMedWashington, DC
Associate Vice President, Global Strategy and Analysis (Asian Region) AdvaMedWashington, DC
Manager, Regulatory Affairs Sequenom, Inc.San Diego, CA
Senior/Principal Mechanical EngineerChannel MedsystemsSan Francisco, CA
Director, Valve Testing - Transcatheter Heart Valve - 001221Edwards LifesciencesIrvine, CA
Strategic Sourcing Manager Alpha Source, Inc.Milwaukee, WI
Senior Director, QualityAmerican Medical SystemsMinneapolis, MN
Click here to view more job listings.

It is astonishing what force, purity and wisdom it requires for a human being to keep clear of falsehoods."
--Margaret Fuller,
American journalist and women's rights activist

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