Medibio Limited announce that it has received CE Mark approval for its sleep staging software, MEBsleep. MEBsleep is a software-only medical device that analyses Electroencephalogram (EEG) and Electrocardiogram (ECG) data collected during polysomnography to verify sleep stages and heart rate variability (HRV) in patients suffering from primary or secondary sleep disturbances. MEBsleep uses artificial intelligence, deep learning algorithms and neural network methodology to analyse large amounts of raw data, including autonomic nervous system modulation throughout sleep stages, to highlight key information to assist the physician in understanding the patient's condition. Currently, the gold standard for identifying sleep stages in a sleep laboratory setting is a 60 to 90 minute visual assessment conducted by a clinician. MEBsleep performs the same assessment in 60 to 90 seconds, thereby providing improved efficacy for overall patient evaluation by sleep medicine technicians, under the supervision of a physician. CE Mark approval will allow Medibio to commercialise MEBsleep across the European Economic Community. The intended users of this device are sleep technicians and researchers. The path is now clear for Medibio to accelerate its commercialization activities for MEBsleep in the EEC. The company is currently exploring commercialization paths with European academic groups and pharma companies focused on behavioural sleep medicine.