Achievement marks key progress toward European regulatory trials
Tuesday, March 5th, 2013: Oxfordshire, England: GlySure Limited, developer of in-hospital continuous blood glucose monitoring systems, today announced that it has achieved ISO 13485 certification, the global standard for the requirements of a quality management system for the design, manufacture and distribution of medical devices. By establishing a quality management system that meets international regulatory and customer requirements, GlySure has set the foundation for its European clinical trials.
“This is an exciting time for our company as we conclude our prototype trials and turn our sights toward securing a CE mark,” said GlySure CEO Chris Jones. “ISO 13485 certification is a key step in this transition as it validates our quality management system and ability to consistently deliver safe and effective technologies to the global marketplace.”
GlySure’s continuous blood glucose monitoring (CBGM) technology meets the clinically documented need for Tight Glycemic Control (TGC) in the Intensive Care Unit (ICU), which has been shown to improve outcomes, reduce mortality and cut the cost of care.
ISO certification is the latest in a series of recent key achievements for GlySure as it prepares for regulatory trials. Over the past year the company has expanded its manufacturing, quality and development teams, opened a new manufacturing facility in Oxfordshire, England and is nearing completion of pre-clinical trials in over 120 ICU patients. GlySure anticipates that it will begin CE mark trials of its CGM system in the second quarter of 2013.
For more information on GlySure, TGC and CBGM technology, visit www.glysure.com.
GlySure has developed a continuous intravascular glucose monitoring system using a proprietary optical fluorescence sensor to meet the $2B+ worldwide demand for implementation of Tight Glycemic Control (TGC) in the hospital Intensive Care Unit (ICU). The company has demonstrated through ICU testing highly accurate sensors, which can provide continuous glucose readings throughout the length of a patient’s stay in the ICU. GlySure was founded in 2006, it is based in Abingdon, Oxfordshire, England and it has 23 employees. The company’s products are not approved for use in the U.S. or Europe. www.glysure.com
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