Acurable Gains FDA Nod for AcuPebble Home Sleep Apnea Testing Device

UK medical device firm Acurable has earned FDA 510(k) clearance for its AcuPebble SA100 home sleep apnea testing device. The small, wearable device provides automated, remote home testing for obstructive sleep apnea (OSA). AcuPebble builds on over ten years of research, headed by Imperial College London professor Esther Rodriguez-Villegas at the college’s Wearable Technologies Lab.
 
AccuPebble generates an instant sleep test result with OSA diagnostic indexes equivalent to gold standard methods like cardiorespiratory polygraphy. Its sensor is tiny and non-invasive, and instructions via a companion mobile app guide patients through the sleep study.
 
The device senses the body’s physiological sounds to spot respiratory and cardiac disease biomarkers. Processed acoustic signals transfer to a mobile device and the cloud, where algorithms then extract parameters needed to diagnose or manage sleep apnea, COPD, and asthma.
 
Current means to diagnose OSA are complex, manual, and expensive. AccuPebble aims to make OSA evaluation quick, easy, and comfortable.
 
California-based Magnap is using AcuPebble in a sleep apnea trial at the University of California San Francisco. Joseph Lamberti, Lead Engineer at MagNap, told the press, “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.”
 
Acurable will next focus over the next two years on expansion into the U.S. market, intending to open a U.S. office next year. The firm is already collaborating with U.S. healthcare organizations.
 
Professor Esther Rodriguez-Villegas, inventor of the AcuPebble technology and founder of Acurable, commented, “Sleep apnea is a condition that affects millions of Americans, and diagnostic bottlenecks lead to the majority not having a timely diagnosis. This not only has serious health implications, but results in billions of dollars being spent on avoidable medical costs. Receiving FDA clearance is a major milestone for Acurable and we are very excited to be able to enter the US market to serve the millions living with undiagnosed sleep apnea.”