Cygnus prepares Glucowatch data for FDA:
This article was originally published in Clinica
Cygnus has begun clinical trials to gather data for an FDA submission for Glucowatch, its automatic glucose-monitor, having completed development trials for the device. Redwood City, California-based Cygnus hopes to submit the data for either an 510(k) clearance or premarket approval application in mid-1999. The device, which is worn like a wristwatch, extracts glucose through the skin with low level electric current and can give up to three readings per hour for 12 hours. Possible future features include an alarm that sounds when glucose levels get too high or low and the ability to store three months data and to download it to a PC. In preliminary trials, involving 232 monitors, the device exceeded its internal accuracy target values by achieving a mean error of 15.6%, says the company.
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