“This device provides an important public health resource for critically ill hospitalized patients, who often have conditions or are taking medications that can cause incorrect blood glucose reading,” said Alberto Gutierrez, director of the Office of In Vitro Diagnostics and Radiological Devices at the FDA’s Center for Devices and Radiological Health.
The FDA determined that the monitoring system was simple to use and had low risk for false results. It granted “waived” status to the system, which allows healthcare professionals to perform the test at the point-of-care instead of requiring the test to be performed in a hospital lab.
The Nova StatStrip Glucose Hospital Meter System, which was originally cleared by the FDA in April 2006 for use in hospitals, is manufactured by Waltham, Mass.-based Nova Biomedical.
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