GlySure Develops Continuous Intravascular Glucose Monitor for Hospital Use

Last year, the FDA released draft guidance for the first time separating out blood glucose monitors specifically for professional use in an institutional, hospital setting from those intended for at-home, consumer use. GlySure next plans to gain an FDA clearance for its Continuous Intravascular Glucose Monitoring System (CIGMS); it is currently designing a trial intended as the basis for an FDA submission.

The GlySure sensor includes a highly selective proprietary chemistry that provides the first commercially available glucose testing system that can accurately measure intravascular glucose levels every fifteen seconds. This breakthrough provides physicians with continual feedback that helps avoid dangerous fluctuations in ICU patient glucose levels. GlySure intends to seek clearance from the U.S. Food and Drug Administration (FDA) for the GlySure CIGMS and is currently finalizing the design of the clinical trial to support its submission.

Read the original articles at FierceMedicalDevices.com:
http://www.fiercemedicaldevices.com/story/glysure-gets-ce-mark-first-continuous-intravascular-glucose-monitor-hospita/2015-07-02
http://www.fiercemedicaldevices.com/press-releases/glysure-secures-ce-mark-and-launches-worlds-first-continuous-intravascular