OXFORD, England, September 25, 2013 /PRNewswire/ --
GlySure Limited, developer of in-hospital continuous blood glucose monitoring (CBGM) systems, today announced the appointment of Justine McQuillan as its European Director of Clinical Affairs. In this newly established position, McQuillan is leading European clinical regulatory trials of GlySure's CBGM technology, which the company expects to complete this fall.
McQuillan has extensive clinical, operational and commercial experience within the MedTech industry, with expertise in the development, evaluation and validation, regulatory clearance and marketing of medical devices and supporting services. She spent eight years at Medicsight PLC, having most recently served as Vice President of Clinical Development. In this role, McQuillan planned, implemented and managed the clinical regulatory strategy to support European, U.S., Chinese and Japanese submissions for regulatory clearance of the company's computer-aided detection medical image analysis products.
"McQuillan's knowledge and experience in successfully guiding a company from R&D through regulatory trials and all the way through to commercialization are the exact qualities we need at this critical juncture of our development," said GlySure CEO Chris Jones. "In addition to leading efforts to secure a CE mark, McQuillan will be working closely with our U.S. trial sites to prepare for U.S. FDA 510(k) regulatory trials."
McQuillan holds a Master of Business Administration from the University of Westminster, London, a Post-graduate Diploma in Management from University of London, and a Diploma in Medical Diagnostic Imaging from Auckland School of Radiography, New Zealand.
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 30 employees. The company's products are not approved for use in the U.S. or Europe. http://www.glysure.com