The FDA has expanded the indication of the Nova StatStrip Glucose Hospital Meter System (Nova Biomedical) for use in critically ill patients who have been hospitalized.
This includes using arterial or venous whole blood from patients with various conditions, such as trauma, cancer, sepsis and infection; cardiac, kidney, neurological, obstetric, gynecological, gastroenterological, endocrine and lung issues; and patients recovering from general or cardiothoracic surgery.
This is the first glucose monitoring system to receive FDA clearance for use in all types of hospital patients, including critically ill patients.
The Nova StatStrip Glucose Hospital Meter System was determined to be simple to use with a low risk for false results. A study evaluated over 1,650 patients with a range of medical conditions, taking various medications, that were being treated in a variety of hospital departments, such as cardiac, emergency intensive care and surgical.
Study results showed agreement in blood glucose results vs. a comparator laboratory glucose analyzer in all patient types tested. It was granted with the clearance “waived” test system status under the Clinical Laboratory Improvement Amendments (CLIA), which allows health care professionals to perform the test at the point-of-care.
The Nova StatStrip Glucose Hospital Meter System was originally cleared in April 2006 for use in hospitals as an aid in monitoring the effectiveness of a diabetes control program.
For more information call (781) 894-0800 or visit NovaBiomedical.com.
This article originally appeared on MPR