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February 11, 2013News for medical technology professionals

  Top Story 
 
  • Zoll gets FDA OK for fully automatic external defibrillator
    The FDA has given Zoll Medical, an Asahi Kasei unit, 510(k) clearance to market its AED Plus system. The newly approved automated external defibrillator, which improves on the semi-automatic version, enables emergency responders to help victims of sudden cardiac arrest by allowing them to preprogram a shock, rather than pressing the "shock" button. MassDevice.com (Boston) (2/8) LinkedInFacebookTwitterEmail this Story
Exporting to Europe: Medical Device Requirements
Join BSI to gain a basic understanding of the CE Marking regulatory process and the impact the Medical Device Directive (MDD) requirements have on marketing a new medical device in the EU. Learn the different medical device risk classifications and when you need a Notified Body. Register Today!
  Business & Market Trends 
 
  International Developments 
  Science & Health 
  • Biosensor device can diagnose diseases better than doctors
    A universal biosensor could take all the guesswork out of a visit to the doctor, leading to more accurate diagnoses and better treatments for illnesses. The PLEX-ID biosensor isolates microbes from saliva or blood to analyze a person's DNA and identify any existing diseases. The device is being used for research purposes, though researchers are hopeful a smaller version could be rolled out for use in doctor's offices. New Scientist (2/6) LinkedInFacebookTwitterEmail this Story
  Emerging Technologies 
  • Optovue scores 510(k) clearance for OCT system database
    Optovue has been cleared by the FDA to incorporate a normative database into the firm's iVue spectral-domain optical coherence tomography device. The iVue SD-OCT technology can use the database to enable the quantitative comparisons of the optic disc and other areas of the eye, as well as tailor OCT scans according to a patient's age, optic disc size and other factors. Healio (2/8) 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.
  Industry Service Providers 
  Government & Regulatory 
  • FDA submits device data gathering proposal for OMB review
    The FDA has submitted for approval by the Office of Management and Budget a proposal to renew its program for gathering data about medical devices as part of its system to identify and ban devices that are harmful or risky. The agency also is requesting public comment on its process for banning medical technologies. MassDevice.com (Boston) (2/8) 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
  • 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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  SmartQuote 
The only man I know who behaves sensibly is my tailor; he takes my measurements anew each time he sees me. ... The rest go on with their old measurements and expect me to fit them."
--George Bernard Shaw,
Irish playwright


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