Medibio (ASX:MEB) has announced it has received CE Mark approval for its sleep staging software, MEBsleep.
CE Mark approval will allow the company to commercialise MEBsleep across the European Union.
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 a range of technologies to analyse large amounts of raw data to assist physicians in understanding a patient’s condition.
The current gold standard for identifying sleep stages in a sleep laboratory setting is a 60 to 90-minute visual assessment conducted. Medibio said MEBsleep performs the same assessment in 60 to 90 seconds.
The company said it is currently exploring commercialisation paths with European academic groups and pharmaceutical companies focused on behavioural sleep medicine.
Claude Solitario, Managing Director of Medibio, said the approval was a significant regulatory milestone.
“MEBsleep is our first marketable product with CE Mark and its approval is an important step on our path towards commercialisation. Furthermore, it is also an important validation as we advance development of our depressive burden software medical device MEB-001, of which MEBsleep is a component,” said Mr Solitario.