This article originally posted 13 December, 2003 and appeared in Issue 185
TheraSense Files Premarket Approval Application for Freestyle Navigator(TM) Cont
St. Petersburg Times, Dec 7, 2003
TheraSense Files Premarket Approval Application for Freestyle Navigator(TM) Continuous Glucose Monitor-- The PMA filing follows recently presented clinical data on Navigator that included results of home-use trials involving 102 subjects at 7 clinical sites. FreeStyle Navigator is a continuous glucose monitor designed to replace traditional in vitro glucose testing by providing users with real time glucose data, hypo- and hyperglycemic alarms and trend analysis. Navigator is designed to measure glucose levels in the patient's interstitial fluid every sixty seconds and transmit the results to a wireless pager-sized receiver that may be worn on a belt or carried in a pocket or purse. More Information as it becomes available.
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