Cygnus GlucoWatch
This article was originally published in The Gray Sheet
Executive Summary
Expedited review status is granted for a September PMA supplement submission for use of the non-invasive glucose monitoring system by diabetics ages 7-17 (1"The Gray Sheet" Oct. 1, 2001, In Brief)...
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Cygnus GlucoWatch
Non-invasive glucose monitoring system indication for use by diabetics ages 7-17 is sought in a PMA supplement submission, announced Sept. 24. The device was approved for adults 18 and older on March 22 (1"The Gray Sheet" March 26, 2001, p. 13). About 100,000 children and 16 mil. adults have diabetes in the U.S. While the wristwatch-like device is currently available under a pilot marketing program, Cygnus is preparing for a full-scale launch and reports to be "in advanced discussions with multiple companies for a potential sales alliance in the U.S."
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