Abbott FreeStyle Navigator® Continuous Glucose Monitoring System, Received European CE Mark

Filed in archive Diabetics' Device , News on June 7, 2007

Abbott's freestyle Navigator® Continuous Glucose Monitoring System is currently an investigational device in the U.S. - still under FDA review and is indicated for adults with diabetes, aged 18 and above.

The device is designed to discreetly measure glucose levels once per minute (without the recurring pain and hassle that can accompany conventional, invasive blood glucose testing) and comes as a three-part system:

PART I: The first part is a sensor designed to be worn for several days. The sensor is attached to a plastic sensor mount with adhesive to adhere to the skin (like a patch). The sensor is placed just under the skin by a disposable self-insertion device.

PART II: The second part is a transmitter, designed to snap into the sensor mount on the skin's surface. The transmitter transmits information wirelessly.

PART III: The third part is a receiver, about the size of a pager, which can be worn easily on a belt, or carried in a pocket or purse. It receives information wirelessly from the sensor / transmitter every minute. The receiver is designed to display glucose values, directional glucose trend arrows, and rate of change. The receiver also has high and low glucose alarms. The receiver can store glucose data for analysis by the user or by a health care provider.

[Go to Abbott Diabetes Care website for more information on this device.]

Recently, Abbott announced that this device product - FreeStyle Navigator® Continuous Glucose Monitoring System - has been granted the European CE (Conformite Europeene) Mark approval, which actually means that the device/product can already enter the European market.

Find more details from Abbott's press release.

[Photo Credit: Abbott Diabetes Care]