Acurable receives FDA 510(k) clearance for its home sleep apnoea testing device
AcuPebble SA100, a small wearable device that enables automated, remote home testing to detect obstructive sleep apnoea (OSA) in adults, has obtained FDA clearance as a Class II medical device in the USA. The device, which received a CE Mark as a Class IIa medical device in 2020, was developed and is commercialised by UK-based medical device company Acurable and builds on more than ten years of research led by Professor Esther Rodriguez-Villegas at the Wearable Technologies Lab in Imperial College London.
AcuPebble provides an instant diagnostic sleep test result which is equivalent in accuracy to the gold standard – cardiorespiratory polygraphy, which requires time consuming clinical interpretation. The AcuPebble sensor is very small and non-invasive. Simple instructions provided by a companion mobile application guide the patient through their sleep study without any training – creating a seamless patient experience. AcuPebble devices sense the physiological sounds generated by the body, detecting, amongst others, respiratory and cardiac disease biomarkers. Processed acoustic signals are transferred to a mobile device and to the cloud, where patented algorithms extract the parameters, doctors need to diagnose or manage conditions such as sleep apnoea, COPD and asthma. Automatic processing means that the demand on a clinician’s time is greatly reduced.
California-based Magnap are using AcuPebble in a sleep apnoea clinical trial at the University of California San Francisco. Joseph Lamberti, Lead Engineer at MagNap, said: “AcuPebble SA100 has been a game changer for us as a research tool for patients who are taking part in our clinical trial. The patients love using it, so much so that some have even asked to use it more often than they need to! For the MagNap team, the fact that AcuPebble provides instant results from easy-to-conduct multiple night studies, in a natural sleep setting, is exactly what we need.”.