Symphony is a non-invasive, wireless system designed to provide accurate, real-time blood glucose data for patients in hospital critical care settings.
The Symphony device met the primary safety and effectiveness points of the trial, Echo reported. The system monitored glucose levels with an error rate of 12.5%, 97.9% of the readings were clinically accurate and 1.8% were benign errors.
“This was the largest study of Symphony to date and it was the 1st time that all of the components of the system were used together in a clinical trial," executive chairman & interim CEO Robert Doman said in prepared remarks. "We believe Symphony demonstrated satisfactory safety, accuracy and reliability during the clinical trial to satisfy CE Mark requirements. We believe that there is great clinical need in the hospital for a non-invasive continuous glucose monitoring system, like Symphony, to support glycemic control protocols in hospital critical care units, leading to improved clinical outcomes."