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March 18, 2013News for medical technology professionals

  Top Story 
 
Streamline Combination Product Development
This complimentary white paper from Novella Clinical explores combination product regulatory strategies - from classification to market clearance. Combination product sponsors can avoid numerous regulatory hurdles by downloading this white paper now: Clarifying the Regulatory Road for Combination Products.
  Business & Market Trends 
  • BioClinica to merge with CoreLab Partners
    BioClinica, a company that oversees medical imaging and data collection for clinical development of drugs and devices, is set to merge with CoreLab Partners. Private equity firm JLL Partners is in the process of acquiring BioClinica and CoreLab to merge the two entities. The Philadelphia Inquirer (3/15) LinkedInFacebookTwitterEmail this Story
  International Developments 
  Science & Health 
  • Device to preserve livers for transplant is used successfully in U.K.
    Two British patients became the first to receive donated livers preserved using an automated perfusion system. The device, being developed by Oxford University researchers, keeps the organ functioning outside the body for longer than 24 hours, maintaining it at body temperature and supplying it with oxygenated red blood cells. Reuters (3/15) LinkedInFacebookTwitterEmail this Story
  Emerging Technologies 
  • Siemens debuts 2 ultrasound devices at cardiology meeting
    Siemens released two ultrasound devices at the 2013 American College of Cardiology meeting. The Acuson SC2000 version 3.0 is designed to quickly produce an accurate biplane estimate of ejection fraction based on apical 2- and 4-chamber images, while the Acuson Freestyle features a portable flat-panel display and a transducer that interacts wirelessly with the monitor. MedGadget.com (3/15) LinkedInFacebookTwitterEmail this Story
  Hot Topics 

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

  • Results based on number of times each story was clicked by readers.
  Industry Service Providers 
  Government & Regulatory 
  • FDA warns Hospira over problems at N.C. plant
    Hospira has received an FDA warning citing 20 issues found at its facility in Rocky Mount, N.C., after a three-week inspection. The company, which develops infusion systems and injectable drugs, said it is cooperating with the FDA regarding the matter and will respond to the findings with a plan for remediation and modernization. MassDevice.com (Boston) (3/14) LinkedInFacebookTwitterEmail this Story
AdvaMed News 
  • Molecular Diagnostics
    Wednesday, June 5 – Thursday, June 6
    Sheraton Crystal City, Arlington, Va.
    In this meeting, FDA and industry speakers will address current regulatory, reimbursement and legislative topics in the evolving field of molecular diagnostics in an interactive two-day program. Attendees will participate in sessions ranging from the latest government policies aimed at molecular diagnostics, health care reform and implications for diagnostics; FDA oversight and regulation of molecular diagnostics; key regulatory considerations in developing molecular diagnostics and what it takes to make a good submission; developments impacting personalized medicine; co-development and the future of companion diagnostics; the changing landscape of molecular diagnostics reimbursement; and an afternoon on future proposals that could foster the introduction of new molecular diagnostics. Visit MTLI online for more information. LinkedInFacebookTwitterEmail this Story
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Position TitleCompany NameLocation
Sales / Technical SpecialistKaneka Pharma America LLCNew York, NY
Sales Area Manager/Sales Rep of Neurovascular Intervention ProductsAsahi Intecc USA, Inc.Any location in US, CA
Sr.Regulatory Affaris AssociateMindray DS USA, Inc.Mahwah, NJ
Project Manager, Regulatory Affairs - Transfusion Medicine Johnson & JohnsonRaritan, NJ
Associate CounselACell, Inc.Columbia, MD
Compliance Consultant 2DJO GlobalVista, CA
Accreditation ManagerAmerican Association of Tissue BanksMcLean, VA
REGULATORY AFFAIRS SPECIALISTMasimo CorporationIrvine, CA
Director, Health Care ComplianceRTI BiologicsAlachua, FL
Manager, HCL Regulatory & Quality ComplianceOwens & MinorLouisville, KY
Click here to view more job listings.

  SmartQuote 
What men value in this world is not rights but privileges."
--H.L. Mencken,
American journalist and essayist


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