News from the FDA/CDC

FDA grants 510k clearance for glucose monitoring system


OptiScan Biomedical Corporation announced Oct. 18 that the Food and Drug Administration 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. It is a bedside glucose monitoring system that provides physicians with critical trending and tracking information to manage patient glucose levels in the ICU.

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In a multi-center clinical trial in 160 surgical intensive care unit patients, results found the OptiScanner 5000 to be safe and accurate for use in patients in the SICU. The study results also showed 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.

It is estimated that roughly 20% of ICU patients have pre-existing diabetes and an additional 40- to- 60% 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.

“There is a broad consensus in the medical community regarding the need for automated, continuous and highly accurate glucose monitoring in the ICU and my experience with the OptiScanner 5000 indicates that this device will play a critical role in delivering this enhanced level of care. I look forward to implementing this technology as soon as possible,” said Grant V. Bochicchio, MD, MPH, FACS, chief of acute and critical care surgery, and Harry Edison Professor of Surgery, Washington University School of Medicine, in a press release.

Read the full press release here.

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