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February 25, 2013News for medical technology professionals

  Top Story 
 
  • Quest to divest HemoCue diagnostic biz for about $300 million
    Radiometer Medical has agreed to acquire Quest Diagnostics' HemoCue business for about $300 million, plus cash balance adjustments, in a deal set to be finalized next month. HemoCue focuses on developing and marketing point-of-care diagnostics, including those used in glucose and hemoglobin testing. RTT News (2/25) LinkedInFacebookTwitterEmail this Story
Is your company's website a potential source for a product liability lawsuit?
Using legal principals and recent cases and development this prerecorded webinar addresses common mistakes that life sciences companies make on their websites. Including how plaintiffs can use your website content to make their cases and ways to avoid these risks. Read More.

  Business & Market Trends 
 
  • Masimo reports sales growth during fourth quarter
    Masimo generated $132.2 million in sales during the fourth quarter of 2012, up 18% from the same period the year before. This year, the company wants to continue to expand its SET pulse oximetry business as well as extend its reach within and outside hospital environments through its rainbow Pulse CO-oximetry platform, CEO Joe Kiani said. MassDevice.com (Boston) (2/22) LinkedInFacebookTwitterEmail this Story
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.

  International Developments 
 
  • Argentina enacts updated medical device regulations
    Changes made to the medical device regulations in Argentina are now in effect, according to this article. The revisions, which will most substantially affect the approval process for Class II, III and IV medical devices, are expected to clarify the medtech registration protocols in that country. MassDevice.com (Boston) (2/22) LinkedInFacebookTwitterEmail this Story
Don't lose access to your customer's facility. We can help.
Rep-Clear: Watermark's Solution for ensuring access to your customers. Rep-Clear includes our proprietary platform for tracking all items associated with a Rep and our professional support staff to provide individual service, ensuring all items are up to date and access to a facility is not lost. View common rep excuses.

  Science & Health 
  • Blaze Bioscience raises $8.5M for tumor imaging technology
    Seattle-based Blaze Bioscience has raised $8.5 million that the company plans to use for clinical development of BLZ-100, which is also called Tumor Paint. The substance illuminates cancer cells, making it easier for surgeons to differentiate diseased tissue from healthy tissue. The cancer cells highlighted by the technology can be visualized with a near-infrared camera. MedCityNews.com (2/22) LinkedInFacebookTwitterEmail this Story
How Much Do You Really Need to Make? The Answer May Shock You
Rather than focus on what you can afford to pull out of the business to cover your living expenses, you need to focus on how much you need to earn at your business in order to afford the lifestyle you want to have. This is where the Personal Earnings Goal, or PEG, comes into play. Learn how to calculate your PEG and find out how much you really need to make.

  Emerging Technologies 
 
Clinical Trial Data Transparency Forum: Expert insights
Hear industry and academic thought leaders - from Duke Clinical Research Institute, GlaxoSmithKline, Eli Lilly and more - share valuable insight on their clinical trial data transparency and sharing initiatives. This video covers a number of key perspectives and trends.

  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 
  • NeuroPace wins FDA panel vote for epilepsy system
    A panel of FDA advisers has voted unanimously in favor of recommending approval for NeuroPace's device designed to reduce episodes of seizures in patients with epilepsy. The implantable device, called the RNS System, works by sending electrical pulses to help disrupt signals in the brain that trigger epileptic seizures. MedPage Today (free registration) (2/22) LinkedInFacebookTwitterEmail this Story
  • Analysis finds improvement in FDA's 510(k) review process
    The number of medical devices cleared within a period of three months under the FDA's 510(k) program improved from 40% in 2010 to 42% in 2011, according to an Emergo Group analysis. The analysis also shows the average time it takes for the FDA to review 510(k) applications dropped from 146 days in 2010 to 138 days in 2011. BeckersOrthopedicAndSpine.com (2/22) LinkedInFacebookTwitterEmail this Story
AdvaMed News 
  • Medical Device Reimbursement Workshop
    Tuesday, Feb. 26 – Wednesday, Feb. 27
    Sheraton Crystal City, Arlington, Va.
    Learn from medical device reimbursement experts what new legislative and regulatory changes apply to the area of reimbursement; the key reimbursement issues for medical technology; how Medicare coverage is determined at the national and local levels; the role of MEDCAC; why technology assessments are important; how clinical trial results impact payers; what you need to do to keep up on new reimbursement developments relevant to your products; how to maintain a nimble, dynamic, effective, ongoing reimbursement program; what to do when reimbursement is denied; drill-down coding systems; differences in inpatient and outpatient payment systems; physician fee schedules and product design; how to negotiate CMS coverage; how to plan for the new health care reform landscape deal with comparative effectiveness; and how to manage international reimbursement. Visit MTLI online for more information. LinkedInFacebookTwitterEmail this Story
  • Investigational Device Exemption (IDE) Submissions Workshop
    Wednesday, Feb. 27
    Sheraton Crystal City, Arlington, Va.
    FDA staff leaders and industry experts at this interactive workshop will lead professionals through the regulatory and practical guidelines governing when an investigational device exemption is required; how to compile effective investigational device exemption applications; the eCopy Program for Medical Device Submissions; the rules governing clinical studies and human subject protection; Institutional Review Boards; types of pre- investigational device exemption meetings and communications; early/expanded access; foreign studies and export; and reimbursement for investigational devices. Visit MTLI online for more information. LinkedInFacebookTwitterEmail this Story
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Position TitleCompany NameLocation
Director, Health Care ComplianceRTI BiologicsAlachua, FL
Manager, HCL Regulatory & Quality ComplianceOwens & MinorLouisville, KY
Clinical Operations ManagerCochlear LimitedSydney, Australia
Director of Global Infrastructure - 002196Edwards LifesciencesIrvine, CA
DIR OPERATIONS, Milpitas Site - 130000007RAbbott San Jose, CA
Biostatistician - Post Market Surveillance Johnson & JohnsonRaynham, MA
Engineer, Process DevelopmentArthroCare CorporationIrvine, CA
Sr. QA Manager - Quality Systems (Santa Barbara)AllerganSanta Barbara, CA
Legal Counsel IIMedtronic, Inc.Minneapolis, MN or Washington, DC, United States
Click here to view more job listings.

  SmartQuote 
It is wonderful how much news there is when people write every other day; if they wait for a month, there is nothing that seems worth telling."
--Anna Masterton Buchan,
Scottish writer


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