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[IP] GlucoWatch

This just came through on USENET this morning.

Hello All,

The following message was just posted to the diabetes world
mailing list by
Jim Reed.
Maybe we'll have an early Christmas present next year!

Gary Krauch, P.E.
DM type I
email @ redacted


Just to let everyone know that today the FDA panel met to
consider approval
of Cygnus' Glucowatch Biographer.  After hearing testimony
and discussing
areas of question or contention, the panel voted to
recommend approval for
marketing of the Glucowatch.  There were several conditions
attached to
marketing approval.

1) That good educational material be developed to make sure
users fully
understood the purpose of the watch and its operation.

2) That some specific wording be included in the labeling.

3) That some post market efforts will be made to study some
hypoglycemia and
hyperglycemia detection issues.

I can't tell you for sure when the Glucowatch will actually
hit the
marketplace but barring something totally unforeseen
between receiving our
panel recommendation and actual approval, we will have a
new tool available
to help us with diabetes management.  The conditions will
be "negotiated"
between Cygnus and the FDA.

I can't go into technical details of the discussion today,
but if you want
more information, there is an report on the Glucowatch
Biographer clinical
results in the November 17th Journal of the American
Medical Association
publication entitled, "Noninvasive Glucose Monitoring:
Clinical Results."  Perhaps it is available through the Web
or you local

*                                   *
*  -- Susan K.  (^i^)               *
*      E-mail: email @ redacted  *
*        Fax: (530) 380-8851        *
*                                   *
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