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FreeStyle Navigator Continuous Glucose Monitor Approved in US

March 17th, 2008 Medgadget Editors Medicine, Pediatrics

The FDA just gave Abbott approval to market its FreeStyle Navigator continuous glucose monitor in the US. The device received the European CE mark of approval last June.
Some features of the system from the product page:

  • Customizable early-warning alarms 10, 20, or 30 minutes in advance to significantly reduce hypoglycemic and hyperglycemic episodes
  • Continuous glucose readings each minute, providing real-time access to information. Only the FreeStyle Navigator system provides readings every minute
  • TRU™ Directional Arrow technology to accurately project glucose direction and rate of change
  • Suitable for everyday activities-including exercise, bathing, and swimming
  • Contains a built-in FreeStyle® meter for convenient calibration (minimum of 4 calibrations averaged over the total 5 day period) and confirmatory blood glucose tests
  • Sensor continuously worn on body for up to 5 days
  • Wireless transmitter sends glucose readings to the receiver anywhere within a 10-foot range
  • Graphs and reports show glucose patterns
  • Press release: FDA Approves Abbott’s FreeStyle Navigator® Continuous Glucose Monitoring System…
    Product page…
    More from Bernard Farrell…

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