Acurable receives US FDA clearance for its home sleep apnoea testing device AcuPebble SA100

AcuPebble SA100, a small wearable device that enables automated, remote home testing to detect obstructive sleep apnoea (OSA) in adults, has obtained FDA 510(k) 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.