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Glucowatch on the fast track for FDA approval
After completing a final series of clinical trials, Cygnus Inc. (Redwood City, CA) has submitted to FDA the second and final module of the premarket approval (PMA) application for its Glucowatch automatic glucose monitor. The PMA will be reviewed by the clinical chemistry and toxicology devices panel at FDA's Center for Devices and Radiological Health, possibly as early as its next scheduled meeting on September 2324.
"FDA has informed us that we will receive expedited processing because the availability of the device as a tool in diabetes management is in the interest of public health," says John C. Hodgman, president, CEO, and chairman of Cygnus.
"People interested in good glucose control need information to manage it effectively," says company chief financial officer Craig Carlson. "The value of this device is that it provides lots of information that hasn't been available before."
The Glucowatch has two components—the monitor, which is worn on the wrist like a watch, and the autosensor, which attaches to the back of the monitor. After one fingerstick blood glucose test is put into the monitor for calibration, the autosensor can perform three glucose measurements an hour for 12 hours.
"Glucowatch gives a real-time readout of data, and it is possible to get a different reading three times an hour," says Carlson. "This device gives people more information than they had before with finger-stick testing. It enables users to make multiple adjustments in their diabetes management based on the information they are getting from the device."—S. W.
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