Acurable Gets FDA’s 510(k) Clearance for Its Sleep Apnea Testing Device

London, UK-based Acurable has received 510(k) clearance from the FDA for its AcuPebble SA100, a wearable device that enables automated, home testing to detect sleep apnea.

The small, noninvasive device provides an instant sleep test result, including obstructive sleep apnea diagnostic measurements equivalent in accuracy to those obtained using the more time-consuming cardiorespiratory polygraphy.  

The device is based on research led by Professor Esther Rodriguez-Villegas at the Wearable Technologies Lab in Imperial College London.