Noninvasive Glucose Monitor Cleared by FDA

A novel monitoring system that provides automatic, noninvasive glucose readings up to three times an hour has been cleared by the U.S. Food and Drug Administration (FDA).

The system, called GlucoWatch Biographer, consists of two integrated parts, the Biographer and the AutoSensor. The Biographer is worn like a watch on the wrist. The AutoSensor snaps into the back of the Biographer and adheres to the skin. The AutoSensor collects the glucose sample by using an extremely low electric current to pull glucose through the skin. The glucose is transformed into an electric signal that is converted into a glucose reading. The Biographer calculates, displays, and stores glucose readings.

The GlucoWatch measures and displays glucose levels automatically, as often as every 20 minutes, for up to 12 hours. It also creates an electronic diary, storing up to 4,000 values that can be reviewed at the touch of a button, helping to detect trends and track patterns in glucose levels. In addition, users can set personal glucose alert levels so that an alarm sounds if readings are too high or too low, or if readings decline rapidly. GlucoWatch is the product of Cygnus, Inc. (Redwood City, CA, USA; www.cygn.com).
Cygnus has received the CE Mark to market the system in Europe. The company notes that the system is not designed to replace the fingerstick testing method but rather to be used together with that method to provide more complete, ongoing information about glucose.

"Cygnus is continuing efforts toward establishing capabilities to distribute and support the GlucoWatch Biographer in select worldwide markets, including the United States and Europe,” said John C. Hodgman, chairman and CEO of Cygnus.





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