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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. MedGadget.com (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. MedCityNews.com (3/8) LinkedInFacebookTwitterEmail this Story
What is the FDA inspector looking for?
FDA inspections can be a significant source of anxiety for drug and device makers. In order to alleviate some of that anxiety, firms need to know what the FDA is looking for during inspections so they can better prepare for them and, thus, increase the likelihood of a positive outcome. This prerecorded webinar can benefit you. Read More.

  International Developments 
 
The New You Starts Here.
Designed for busy healthcare professionals, FIU's online Healthcare MBA is transformative. Graduates emerge ready for a leadership role in healthcare, with a clear vision of how to lead collaboratively and advance the business of healthcare. Classes begin Fall 2015. Start here.

  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. MedCityNews.com (3/8) LinkedInFacebookTwitterEmail this Story
Pay HCPs…Not Penalties!
Receive invoices, process invoices, pay HCP, track payment, report payment, argue with HCP, issue 1099, perform due diligence…start again. Supporting HCP consultants and speakers can be a big task. Watermark has a turnkey solution to meet your needs, support you HCP, and keep you in compliance.

  Emerging Technologies 
Get Creative: 10 Ways to Think Outside the Box
No matter your business, smart solutions come from out-of-the-box thinking. We all know creativity is king, but are you doing all you can to inspire and encourage creativity in your staff? Read the article and learn 10 ways to inspire creativity at your office.

  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. MassDevice.com (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
  • Follow AdvaMed on Google+
    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
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
REGULATORY AFFAIRS SPECIALISTMasimo CorporationIrvine, CA
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.

  SmartQuote 
The greatest way to live with honor in this world is to be what we pretend to be."
--Socrates,
Greek philosopher


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