FOR IMMEDIATE RELEASE: January 29, 2016
Contact: Ron Newby
(781) 647-3700 ext. 350
RNewby@novabio.com
StatStrip Glucose Xpress 2 Hospital Meter System Receives FDA Clearance
for Use with Critically Ill Patients
Waltham, MA – On January 27, 2016, the Food and Drug Administration (FDA) cleared Nova’s StatStrip Glucose Xpress 2 Hospital Meter System for use throughout all professional healthcare settings, including with critically ill patients.
StatStrip Glucose Xpress 2 utilizes the same glucose measurement technology as StatStrip Glucose and StatStrip Glucose Xpress. StatStrip Glucose technology has been studied extensively and is proven to be free of clinically significant interferences and to demonstrate excellent agreement compared to central laboratory reference methods.
StatStrip Glucose, StatStrip Glucose Xpress, and StatStrip Glucose Xpress 2 are now the only three hospital glucose meters to be cleared by the FDA and proven to be safe and effective for use throughout all hospital and professional healthcare settings, including with critically ill patients. Use of any other strip-based glucose meter with critically ill patients is considered “off-label” by the FDA and Centers for Medicare and Medicaid Services.
StatStrip Glucose Xpress 2 features a new color screen and modern shape for easier use. Nova Biomedical will release StatStrip Glucose Xpress 2 in 2016.
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, as well as providing the biotechnology industry with the most advanced instruments for cell culture monitoring. Nova is one of the fastest growing in vitro diagnostic companies in the world. Nova’s 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’s biotechnology-specific BioProfile line has pioneered comprehensive cell culture testing, providing over 20 critical cell culture tests with over 12 unique instrument offerings for broad range of cell culture applications. Nova employs over 1,100 people worldwide and has wholly owned subsidiaries located in Brazil, Canada, France, Germany, Great Britain, Italy, Japan, and Taiwan. Certified by the International Organization for Standardization, Nova has manufacturing operations located in the U.S., Taiwan, and Brazil. www.novabiomedical.com