OptiScan Biomedical Receives CE Mark for OptiScanner Automatic Bedside Glucose Monitoring System
Certification Enables European Sale and Marketing of World’s First Automated Device Designed to Continuously Monitor Glucose Levels in Critically Ill Patients
Hayward, CA, September 19, 2011 – 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..... Read more
