GlySure has received the CE Mark for continuous intravascular glucose monitoring system (CIGMS).
The initial use of the system will improve blood glucose management in adult cardiac surgery patients in the intensive care unit (ICU).
The GlySure CIGMS features three main parts, which include a monitor, a disposable fibre optic sensor and a disposable 5 lumen central venous catheter.
The company is currently undertaking a UK-based multicentre trial to allow the utilization of CIGMS in all adult ICU patients.
GlySure said poorly controlled blood sugar levels can result in increased mortality, morbidity, lengths of stay in the ICU and costs to healthcare providers in critically ill patients.
The CE Mark allows GlySure to market CIGMS in Europe. It will initially be launched in critical care centers across the UK, Benelux and Germany, followed by other countries.
GlySure chief operating officer Roger Moody said: "We are pleased to bring to market the first practical solution to address this significant unmet medical need.
"Our first customers will lead the way in how glucose management is best practised, enabling improved patient outcomes and reduced healthcare costs. Continuous glucose monitoring in critical care has been a vexing medical challenge."
GlySure is planning to secure clearance from the US Food and Drug Administration (FDA) for CIGMS. The design of the clinical trial is being finalized for its submission.