OptiScan Biomedical announced the US Food and Drug Administration (FDA) has granted 510(k) clearance for the OptiScanner 5000 Glucose Monitoring System. The clearance allows the device to be used for monitoring plasma glucose levels and determining dysglycemia in surgical intensive care unit (SICU) patients. The OptiScanner 5000 is the first-of-its-kind automated, bedside glucose monitoring system that provides physicians with critical trending and tracking information to manage patient glucose levels in the ICU.
The clearance by FDA was based on results from OptiScan's pivotal, multi-center clinical trial in 160 surgical intensive care unit patients comparing the accuracy of the OptiScanner 5000 to industry standard glucose measurement in the ICU. Results from the study demonstrated the OptiScanner 5000 to be safe and accurate for use in patients in the surgical intensive care unit. As with previously completed clinical studies of the OptiScanner 5000, these pivotal study results highlighted the ability of the device to combine accurate plasma glucose measurement with the convenience of continuous, real-time bedside monitoring, and alarms which notify clinicians of excursions from the desired glucose range.
"This clearance by FDA is incredibly gratifying for the entire OptiScan team. We, along with many other companies in the medical device space, have dedicated considerable time and effort toward the goal of bringing continuous glucose monitoring technology into the ICU. We are proud to be the first company to have achieved success in the form of a regulatory clearance by FDA," said Peter Rule, chairman and chief executive officer of OptiScan Biomedical. "We believe the OptiScanner 5000 is well positioned to assist clinicians to improve the management of hyperglycemia and hypoglycemia in surgical intensive care unit patients."
The OptiScanner 5000 represents an advancement in the delivery of care to SICU patients by automating the measurement of patients' plasma glucose, as opposed to current manual measurement of glucose in whole blood. It is estimated that approximately 20 percent of ICU patients have pre-existing diabetes and an additional 40 to 60 percent of ICU patients suffer from "stress hyperglycemia" or a temporary elevation of glucose levels, with all of these patients requiring accurate glucose monitoring to maintain glycemic control.
In addition to the FDA clearance, the OptiScanner 5000 has previously received CE Mark certification for use in the European Union.