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March 11, 2013News for medical technology professionals

  Top Story 
  • Merit's microspheres for enlarged prostate win EU approval
    Merit Medical Systems has obtained CE mark approval in Europe to market its Embosphere Microspheres for use in relieving symptoms of benign prostatic hyperplasia, or enlarged prostate, in men. The devices hinder the prostate's ability to grow by obstructing blood flow in selected vessels around it. (3/8) LinkedInFacebookTwitterEmail this 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 
  • Ampio Dx unit eyes $5M for device to measure oxidative stress
    A regulatory filing disclosed that Luoxis Diagnosis is seeking to obtain $5 million in a private placement. The company was recently formed by Ampio Pharmaceuticals to help bring its Oxidation Reduction Potential technology, a diagnostic platform that uses a drop of blood to evaluate total oxidative stress, to market. (3/8) LinkedInFacebookTwitterEmail this Story
  International Developments 
  Science & Health 
  • Study: Edwards' Sapien XT heart valve is comparable to older model
    A study presented at a cardiology meeting in San Francisco found Edwards Lifesciences' Sapien XT to be potentially more convenient to use and just as effective as the original model in treating a calcified aortic valve in the heart. Researchers said the results should back FDA clearance for the device, which the company plans to pursue in the second quarter. Bloomberg Businessweek (3/10) LinkedInFacebookTwitterEmail this Story
  • Army awards $2.5M for work on TBI screening device
    The U.S. Army has awarded NeuroWave Systems $2.5 million to develop SeizTBI, a wearable device that medics can use to detect traumatic brain injury among soldiers in combat. The system is a miniaturized model of the firm's NeuroFAST brain monitor cleared by the FDA and will be used to automatically capture electroencephalogram data to identify early TBI signs. (3/8) LinkedInFacebookTwitterEmail this Story
  Emerging Technologies 
  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.
  Government & Regulatory 
  • FDA critic calls for independent post-market device, drug oversight
    The responsibility of overseeing market-available drugs and devices should be transferred from the FDA to an independent bureau similar to the National Transportation Safety Board, Dr. Robert Hauser argued during the American College of Cardiology conference. "The FDA is being asked to approve devices and then to be responsible for monitoring performance for devices and drugs," Hauser said. "Right away, you have a conflict because the group that approved the drug is going to question the group that is now criticizing the drug." LinkedInFacebookTwitterEmail this Story
  • Boston Scientific addresses concerns over lead-free defibrillators
    Boston Scientific is offering a software update for its lead-free implantable defibrillators after receiving reports of a fuse malfunction that may cause the systems to not work properly. "We recommend patients with recently implanted S-ICDs meet with their doctors for a follow-up visit to receive the software update," company official Denise Kaigler said. (Boston) (3/8) LinkedInFacebookTwitterEmail this Story
AdvaMed News 
  • Medical Device Tax Workshop
    Wednesday, March 13 -- Thursday, March 14
    Sheraton Crystal City, Arlington, Va.

    Join tax professionals in discussing how to implement the new medical device 2.3% excise tax. Medical device tax experts discuss how to implement these tax changes. Interact in educational sessions and collaborative lessons, and discuss with other industry affiliates concerns with the medical device excise tax. Medical device tax leaders navigate you through these tax changes by identifying key issues such as: identifying taxable medical devices; taxable and non-taxable uses; combination products; bundled services; exemptions; reporting; exclusions; rebates; payment; penalties; accounting systems; and ruling guidance. Visit MTLI online for more information. LinkedInFacebookTwitterEmail this Story
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Position TitleCompany NameLocation
Sales Area Manager/Sales Rep of Neurovascular Intervention ProductsAsahi Intecc USA, Inc.Any location in US, CA
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
Director, Health Care ComplianceRTI BiologicsAlachua, FL
Manager, HCL Regulatory & Quality ComplianceOwens & MinorLouisville, KY
DIR OPERATIONS, Milpitas Site - 130000007RAbbott San Jose, CA
Biostatistician - Post Market Surveillance Johnson & JohnsonRaynham, MA
Click here to view more job listings.

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Greek philosopher

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