While the Cygnus Glucowatch Biographer is not truly “noninvasive”
(it requires one conventional finger-stick every 12 hours for calibration),
it is the closest thing we have at this time, and many people want to know
when they can get one. The Glucowatch is new technology, and many different
components and manufacturing processes have required FDA approval. As of November
1, 2001, that process is apparently complete.
John Hodgman, Cygnus's president and CEO, states: “With the recent FDA approvals of all outstanding pre-market approval supplements, the key elements for launching the GlucoWatch Biographer in the U.S. are falling into place. The distribution and customer support functions are ready. We anticipate the first sales in the U.S. during the first quarter of 2002.”
Basic FDA approval, in most cases, consists of permission to market an item for use with adults. On November 6, Cygnus announced its application for approval to market the Glucowatch for use with children and adolescents (ages 7-17) will receive “expedited review,” promising a faster decision on its marketing to this age group.
Although Cygnus has started to run ads about
the Glucowatch, it is not yet commercially available. With the developments
listed above, we shouldn't have long to wait. Until then, best source for
information is the website: www.glucowatch.com