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.

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.

OSA is one of the most common serious respiratory disorders, affecting approximately 1 billion people globally. The condition causes sufferers to repeatedly stop breathing while sleeping. If left untreated, OSA can lead to serious health complications including high blood pressure, heart attack, type 2 diabetes, and dementia. It is also the cause of 25% of road accidents due to tiredness. However, current diagnosis methods are complex, manual, and expensive, a problem that AcuPebble sets out to address by making OSA evaluation easy and comfortable for patients and clinicians.

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.”

Professor Esther Rodriguez-Villegas, inventor of the AcuPebble technology and founder of Acurable, added: “Sleep apnoea is a condition that affects millions of people, and diagnostic bottlenecks lead to the majority not having a timely diagnosis. This not only has serious health implications, but also leads to massive unnecessary medical costs further down the line. With adoption of AcuPebble SA100 in Europe growing rapidly, and now FDA clearance, we are very excited to bring AcuPebble to as many people as possible living with undiagnosed sleep apnoea.”

Having obtained FDA clearance, Acurable’s focus over the next two years will be expansion into the US market, where OSA affects at least 25 million adults. The company will open an office in the USA in 2022 and is already working with US healthcare organisations.