FDA gives 510(k) approval of OptiScanner 5000 Glucose Monitoring System for critical care.- OptiScan Biomedical Corp.

OptiScan Biomedical Corporation announced that the 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 other 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.