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OptiScan Biomedical Receives CE Mark for OptiScanner Automatic Bedside Glucose Monitoring System
Date:9/19/2011

HAYWARD, Calif., Sept. 19, 2011 /PRNewswire/ -- OptiScan Biomedical Corporation, a developer of innovative continuous glucose monitoring systems for use in intensive care units (ICU), today announced that the company's OptiScanner™ Automatic Bedside Glucose Monitoring System has received CE Mark certification for use in the European Union.  This CE Mark certifies that the OptiScanner has met all relevant European Union consumer safety, health and environmental requirements, allowing it to be sold and marketed in the 30 countries that make up the European Economic Area (EEA).  The company plans to initiate marketing of the OptiScanner during the first quarter of 2012, and is presently engaging in dialogue with appropriate distributors in the various countries.  Additionally, OptiScan is currently in active discussions with the United States Food and Drug Administration regarding the approval of the OptiScanner in the U.S.  

The OptiScanner is a first-of-its-kind automated, bedside glucose monitoring system that overcomes the limitations of today's current handheld, manually operated glucose meters and provides physicians with the tools and information they need to best manage patient glucose levels in the ICU.  The device represents a significant advancement in the delivery of care to ICU patients by helping to combat both hyperglycemia and hypoglycemia through automated monitoring of patients' glucose in plasma, as opposed to whole blood.  It is estimated that approximately 20 percent of ICU patients have pre-existing diabetes and an additional 40 to 70 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 tight glycemic control.

"There is a very real crisis related to patient blood glucose levels that is being played out daily in ICUs around the world.  With hyperglycemia, hypoglycemi
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SOURCE OptiScan Biomedical Corporation
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