Nova StatStrip Xpress Glucose Hospital Meter System Receives FDA Clearance Use with Critically Ill Patients
Posted May 26th, 2015.
FOR IMMEDIATE RELEASE: May 26th, 2015
Contact: Ron Newby, Director of Marketing
(781) 647-3700 ext. 350
Nova StatStrip Xpress Glucose Hospital Meter System Receives
FDA Clearance Use with Critically Ill Patients
StatStrip Xpress Glucose joins StatStrip Glucose as only two hospital glucose meters
FDA-cleared for use with critically ill patients
Waltham, MA – On May 20, 2015, the U.S. Food and Drug Administration (FDA) cleared Nova Biomedical’s StatStrip Xpress Glucose Hospital Meter System for use throughout all hospital and all professional healthcare settings, including critically ill patients.
StatStrip Glucose and StatStrip Xpress Glucose are now the only two hospital blood glucose meters to be cleared by the FDA for use with critically ill patients. Use of all other glucose meters with critically ill patients is considered off-label by the FDA and high complexity testing under the Clinical Laboratory Improvement Amendments. High complexity testing requirements are so stringent that to use a glucose meter other than StatStrip Glucose and StatStrip Xpress Glucose with critically ill patients is not a practical alternative.
StatStrip Xpress Glucose utilizes the same test strip measurement technology as StatStrip Glucose, which was cleared in 2014 after an extensive, four-year study conducted at five major university medical centers. The study included 1,698 critically ill patients with over 257 medical condition subcategories as designated by the World Health organization. Over 8,000 medications were investigated for potential interference to StatStrip Glucose measuring technology. StatStrip Glucose demonstrated excellent agreement compared to central laboratory reference methods and no clinical interferences were found.
In addition to the study submitted to the FDA, 138 other independent studies over the last eight years—including 53 critical care studies—have found no clinically significant interferences for StatStrip Glucose measuring technology. This is a statement that no other glucose meter manufacturer can make. StatStrip Glucose and StatStrip Xpress Glucose are the world’s most extensively studied and proven glucose tests.
About Nova Biomedical
Incorporated in 1976 and based in Waltham, MA, Nova Biomedical is a world leader in the development and manufacturing of state-of-the-art, whole blood, point-of-care and critical care analyzers, and is one of the fastest growing in vitro diagnostic companies in the world. Nova’s whole blood biosensor technology is incorporated in products ranging from handheld meters for glucose self- and point-of-care testing to critical care whole blood analyzers designed for rapid measurement of over 20 analytes. Nova employs over 1,000 people worldwide and has wholly owned subsidiaries located in Canada, France, Germany, Great Britain, Japan, and Taiwan. Certified by the International Organization for Standardization, Nova has manufacturing operations located in the U.S., Taiwan, and Brazil.