Nova StatStrip Glucose hospital meter system receives FDA clearance

Sept. 26, 2014

Nova Biomedical’s StatStrip Glucose hospital meter system has received clearance from the U.S. Food and Drug Administration (FDA) for use throughout all hospital and all professional healthcare settings, including intensive care settings. The announcement comes after an extensive, four-year consultation with the FDA and five prestigious university medical centers.

Because of the high rate of adverse patient events linked to the point-of-care (POC) use of glucose meters within hospitals, the FDA has recognized the need for more accuracy and better performance standards for POC glucose testing in hospitals, particularly in intensive care. In 2010 Nova Biomedical met with the FDA to define the rigorous studies necessary to clear StatStrip Glucose for use throughout all patient populations and all hospital settings. Studies included extensive evaluations in intensive and critical care settings with patients receiving intensive medical intervention/therapy.

All of the performance assessment tools, including the insulin dosing risk models, demonstrated that StatStrip Glucose has acceptable clinical performance within intensive care settings when testing is performed by healthcare professionals or point-of-care waived operators. Also, StatStrip Glucose demonstrated substantial equivalence to central laboratory IDMS traceable reference methods, when used with patients receiving intensive medical intervention/therapy. Learn more about StatStrip point-of-care glucose monitoring.

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