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January 21, 2013News for medical technology professionals

  Top Story 
  • BD Medical gains FDA approval for drug transfer device
    The FDA has granted BD Medical approval for a device used to make it safe to handle hazardous medications by securing them in a pressure-controlled and sealed system. The technology, called BD PhaSeal Closed System Transfer Device, has demonstrated leakproof and airtight performance in 19 peer-reviewed studies. (1/18) 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.

  Business & Market Trends 
A Buyer's Guide to Web CMS
A Web CMS (Content Management System) makes it easier for you to create, manage and maintain your website content, and choosing a Web CMS is a big decision for your company. It's critical to look for and understand the essential features that will address your business needs now and in the future. This guide will help you make a more informed Web CMS selection.

  International Developments 
  • St. Jude's stroke prevention device wins approval in Europe
    European regulators have given St. Jude Medical CE mark approval to market its AMPLATZER Amulet Left Atrial Appendage Occluder. The device, patterned after the company's AMPLATZER Cardiac Plug approved in Europe four years ago, is intended to help prevent stroke in patients with non-valvular atrial fibrillation. (1/18) LinkedInFacebookTwitterEmail this Story
  Science & Health 
  • Study: Blood test may predict mortality risk in trauma cases
    Researchers in Utah found that an algorithm applied to the simple blood test that patients receive when they are admitted to the hospital can help doctors estimate the risk of death in trauma patients. The Intermountain Risk Score is a computerized algorithm that determines components of a complete blood count and other factors and can yield results in about one hour. Researchers said the test could improve decision-making for trauma-patient management and should be considered as part of a care plan model. The Deseret News (Salt Lake City) (1/18) LinkedInFacebookTwitterEmail this Story
  Emerging Technologies 
  • Diabetes management systems from Glooko get FDA OK
    Glooko has been cleared by the FDA to market its suite of nonprescription diabetes management systems intended to make it easier to measure food intake, glucometer readings and other key parameters. The clearance applies to the company's MeterSync Cable, Logbook and Logbook Charts applications. (1/18) LinkedInFacebookTwitterEmail this Story
  • Could a transplant of fake feces save your life?
    A transplant of fake feces could be the next medical treatment necessary to help fight recurring bacterial infections. The fake feces, a "super-probiotic" dubbed RePOOPulate, would replace existing real fecal transplants used to treat patients with Clostridium difficile bacteria infections. (1/17) LinkedInFacebookTwitterEmail this Story
  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 
  • Sanovas files 510(k) clearance for lung catheter device
    Sanovas has submitted an FDA application for a 510(k) clearance to market its Vas Zeppelin Smart Catheter, which is used for the diagnosis and treatment of lung cancer and chronic pulmonary conditions. The move is part of the company's three-pronged strategy to pursue FDA OKs for its more than 37 devices and six product lines. (Boston) (1/17) LinkedInFacebookTwitterEmail this Story
AdvaMed News 
  • 510(k) Submissions Workshop
    Monday, Feb. 25 -- Tuesday, Feb. 26
    Sheraton Crystal City, Arlington, Va.
    Join quality and regulatory professionals at this interactive 510(k) workshop. Industry experts and key personnel from the FDA CDRH and CBER 510(k) staff inform you in detail on current FDA updates to the 510(k) process (eCopy Program for Medical Device Submissions); a step-by-step walk-through of the 510(k) regulatory guidelines; 510(k) practical steps and strategic considerations for determining a product's regulatory route to market; identifying a predicate device; planning and assembling a 510(k) submission; interacting with the FDA during the 510(k) review process; 510(k) post-clearance issues; and the Refuse to Accept Policy for 510(k)s.  Visit MTLI online for more information. LinkedInFacebookTwitterEmail this Story
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Position TitleCompany NameLocation
Product Support Specialist IVArthroCare CorporationAustin, TX
Director of Clinical AffairsEndologixIrvine, CA
Sr. Clinical Research AssociateEndologix, Inc.Irvine, CA
Quality Systems ManagerRoche DiagnosticsIndianapolis, IN
Regulatory Affairs Clinical SpecialistMindray DS USA, Inc.Mahwah, NJ
Area Reimbursement Manager (Central U.S. or Northeast U.S.)SI-BONE, IncMultiple Locations, United States
Program Director, Regulatory AffairsJohnson & JohnsonFremont, CA
Click here to view more job listings.

Give me six hours to chop down a tree and I will spend the first four sharpening the axe."
--Abraham Lincoln,
16th U.S. president

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