Nova Biomedical, Waltham, Mass, has received FDA clearance for its StatStrip Xpress glucose hospital meter system to be used in all hospital and professional healthcare settings, including sites for critically ill patients.
The StatStrip Xpress glucose hospital meter utilizes the same test strip measurement technology as the company’s StatStrip glucose meter, which was cleared in 2014 after an extensive, 4-year study conducted at five major university medical centers. The study included 1,698 critically ill patients with more than 257 medical condition subcategories as designated by the World Health Organization. Over 8,000 medications were investigated for potential interference with the StatStrip glucose measuring technology. The glucose meter demonstrated excellent agreement compared to central laboratory reference methods and no clinical interferences were found.
In addition to the study submitted to FDA, 138 other independent studies over the past 8 years—including 53 critical care studies—have found no clinically significant interferences for the StatStrip glucose measuring technology.
For more information, visit AACC booth 1226 or Nova Biomedical.