This article was originally published in The Gray Sheet
Submission of a modular PMA for the GlucoWatch continuous glucose monitor should be complete by June, the company announces Jan. 7. The PMA will include results from completed clinical studies of 500 subjects performed in laboratory, home simulated, and normal home environments. In addition, Cygnus plans to initiate two 30-patient studies later this quarter that were suggested by FDA during December discussions. The agency has tapped the application for expedited review, Cygnus says
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