The U.S. Food and Drug Administration has approved a new indication for a blood glucose monitoring system, extending its use to critically ill patients who have been hospitalized and making it the first system of its kind to be cleared for use in these types of patients.
The handheld Nova StatStrip Glucose Hospital Meter System from Nova Biomedical in Waltham, Mass., has the distinction of being the first FDA-approved device specifically indicated for use in all types of hospital patients. The device was originally cleared by the FDA in April 2006 for use in hospitals as an aid in monitoring the effectiveness of a diabetes control program, but not for use with critically ill patients. However, Nova Biomedical submitted a new premarket submission to the regulatory agency seeking clearance of the device with this new indication.
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