Nova StatStrip, a Hematocrit and Electrochemical Interference Correcting Clinical Glucometer, FDA Cleared

Nova Biomedical (Waltham, MA) won FDA clearance for its StatStrip Glucose Hospital Meter System, an accurate clinical level device for use anywhere from the neonatal ward to the intensive care unit. It is the first FDA-cleared device that has been cleared for blood sugar metering and management in all professional healthcare settings. The device measures hematocrit, the volume percentage of red blood cells that can affect glucose readings, and automatically corrects to provide an accurate result. Additionally, the device also adjusts for any electrochemical interference, including acetaminophen, ascorbic acid, and maltose, that may skew the results and adjusts to compensate for those as well. Details of the study that led to the clearance according to the press release: The announcement comes after an extensive, four-year project with the FDA and five prestigious university medical centers. It represents a landmark clinical breakthrough in improved patient care and safety. Because of the unacceptably high rate of adverse patient events, including deaths, linked to the point-of-care (POC) use of glucose meters within hospitals, the FDA recognized the need for more accuracy and better performance standards for POC glucose testing in hospitals, particularly in intensive care settings. Nova recognized this need in 2010 and met with the FDA to define the rigorous studies necessary to clear StatStrip Glucose for use throughout all patient populations and all hospital settings. Stu...
Source: Medgadget Anesthesiology - Category: Anesthesiology Authors: Tags: Anesthesiology Critical Care Medicine Pediatrics Source Type: news