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March 19, 2013News for medical technology professionals

  Top Story 
  • FDA OKs 2 HUD designations for artificial heart from SynCardia
    The FDA has granted SynCardia Systems humanitarian use device exemption approval for its 50cc Total Artificial Heart to be used as a bridge-to-transplant for pediatric patients and others with small stature. The device also received HUD approval as a destination therapy system for heart failure patients at risk of imminent death. (Boston) (3/18) LinkedInFacebookTwitterEmail this Story
Devices are Healthcare's Hottest Commodity in '13
If Charles Dickens were alive today and wrote for Medical Device Daily he might be inclined to use his familiar opening line of "A Tale of Two Cities" to describe the current state of the med-tech industry: It was the best of times, it was the worst of times. Find out the details.

  Business & Market Trends 
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 
  Science & Health 
  Emerging Technologies 
  • 3D ear scanner from Lantos scores FDA clearance
    The FDA has cleared Lantos Technologies to market its 3D ear scanning device. The scanner, set to be released later this year, allows for the development of hearing aid devices that are customized to each patient by streamlining the way ear topology is measured, according to the company. Boston Herald (3/18) LinkedInFacebookTwitterEmail this Story
  • Salivary duct access devices from Cook Medical are available
    A set of salivary duct access tools has been released by Cook Medical through its new Otolaryngology—Head and Neck Surgery business unit. The products, which are used to remove occlusions in the salivary duct, include the Kolenda salivary access introducer set, the NGage and NCircle salivary stone extractors, a serial dilator set and a guide wire. (3/18) LinkedInFacebookTwitterEmail this Story
  Government & Regulatory 
  • Proposed budget hike would increase FDA oversight in China
    A Senate bill that aims to raise the FDA's fiscal 2013 budget to $2.5 billion has gained support from the Alliance for a Stronger FDA, which calls it "strongly favorable" to the agency. The measure, which includes the new user fees for medical devices, drugs and biologics, provides $10 million to allow the agency to beef up its inspections in China, the group said. (3/18) LinkedInFacebookTwitterEmail this Story
AdvaMed News 
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    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
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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
Director, Health Care ComplianceRTI BiologicsAlachua, FL
Manager, HCL Regulatory & Quality ComplianceOwens & MinorLouisville, KY
Click here to view more job listings.

You may have to fight a battle more than once to win it."
--Margaret Thatcher,
British prime minister

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