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February 4, 2013News for medical technology professionals

  Top Story 
  • Edap seeks FDA approval for prostate cancer device
    Edap TMS, a medical device firm based in France, has submitted to the FDA a premarket approval application for its Ablatherm-HIFU system. The high-intensity focused ultrasound system is intended for the noninvasive treatment of patients with localized, low-risk prostate cancer. (Boston) (2/1) LinkedInFacebookTwitterEmail this Story
7 keys: Put real-world evidence into action
Life sciences organizations need to know how their therapies work in the real world once clinical trials end. And these seven key components to standardizing real-world data and analytics platforms are how they get started. Read the paper, Institutionalizing Real World Evidence.
  Business & Market Trends 
  • Ivantis gets $27M boost for trials of microstent in eye patients
    A round of Series B financing led by Ascension Health Ventures has brought in $27 million for Ivantis. The company will use the money to conduct four global clinical studies of its Hydrus microstent, a tiny device that assists in restoring a glaucoma patient's natural eye outflow pathway. Healio (1/31) LinkedInFacebookTwitterEmail this Story
  International Developments 
  • Former Medtronic exec lands chairman role at Mainstay Medical
    Mainstay Medical, which is developing an implantable device used to help treat patients with chronic low back pain, has tapped Dr. Oern Stuge to serve as its new chairman. Stuge comes from Swiss medtech consulting firm Orsco Life Science and has previously held executive positions at Medtronic, Abbott Laboratories and Medinor. The Irish Times (Dublin) (1/31) LinkedInFacebookTwitterEmail this Story
  Science & Health 
  Emerging Technologies 

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  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 
  • Expanded Medicare competitive bidding gets pushback from AdvaMed: AdvaMed has expressed concern over CMS's decision to push ahead with plans to expand its competitive bidding prgram for durable medical equipment. "The competitive bidding program is built in such a way that the lowest bid -- which may not be the right bid -- may compromise patient access to products best suited for their needs," AdvaMed President Stephen Ubl said. (Boston) (2/1) LinkedInFacebookTwitterEmail this Story
  • CryoLife gets warning letter over manufacturing concerns
    The FDA has issued a warning letter to CryoLife saying that the company failed to sufficiently fix earlier issues regarding manufacturing practices tied to some of its products. CryoLife will cooperate with the FDA in addressing the concerns raised in the letter, according to the company, which develops surgical devices and instruments. Reuters (2/1) 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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    Stay updated on industry news and educational opportunities -– receive an intimate understanding of the key issues affecting innovation, access and the bottom line. Network with industry experts and leaders. Our Google+ page is interactive and incorporates updates from key stakeholders, influencers and industry thought leaders as well as regulatory and policy experts from the FDA and CMS. Follow us on Google+. LinkedInFacebookTwitterEmail this Story
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Position TitleCompany NameLocation
Neurovascular Intervention Marketing ManagerAsahi InteccSanta Ana, CA
Sr. QA Manager - Quality Systems (Santa Barbara)AllerganSanta Barbara, CA
Regional Service Manager PhilipsHartford, CT
Product Support Specialist IVArthroCare CorporationAustin, TX
Director of Clinical AffairsEndologixIrvine, CA
Sr. Clinical Research AssociateEndologix, Inc.Irvine, CA
Area Reimbursement Manager (Central U.S. or Northeast U.S.)SI-BONE, IncMultiple Locations, United States
Program Director, Regulatory AffairsJohnson & JohnsonFremont, CA
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Chinese philosopher

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