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.1 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, is a world-renowned scientist and has been awarded some of the highest recognitions in her field. She commented: “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.2 The company will open an office in the USA in 2022, and is already working with US healthcare organisations.
About AcuPebble
AcuPebble SA100 is a home sleep apnoea testing device launched in the UK in late 2020, following completion of a large clinical trial conducted at the Royal Free Hospital in London that demonstrated the safety and effectiveness of AcuPebble SA100 against multi-channel polygraphy (94% positive predictive value, 98% negative predictive value).3
AcuPebble is the first wearable medical device to obtain the CE mark in Europe for the automated testing of obstructive sleep apnoea at home, without requiring patients to be trained by a healthcare professional, with positive and negative likelihood ratios over 10 and below 0.1, respectively. The device has also recently obtained FDA 510(k) clearance for OSA evaluation in adults.
AcuPebble systems operate on the principle of acoustic sensing, whereby the body’s physiological functions generate sounds that can be sensed, processed and recorded with a proprietary non-invasive wearable sensor. The acoustic signals are then transferred wirelessly to a mobile device and to the cloud, where patented algorithms automatically extract the physiological parameters used by doctors for the diagnosis and management of important conditions such as sleep apnoea, COPD and asthma. These algorithms reduce the need for clinicians to spend large periods of time interpreting data, so doctors only need to spend a total of ~30 mins per patient with AcuPebble compared to 2-3 hours with polygraphy.
The technology is a breakthrough in respiratory medicine and has been recognised with a prestigious XPRIZE and several Innovate UK grants. Following its launch, the product was chosen through a rigorous selection process to join the NHS Innovation Accelerator, a programme run by NHS England and NHS Improvement that supports promising innovations for wide adoption across NHS England for the benefit of patients, populations and NHS staff. AcuPebble is now being used in several hospitals in the UK and Europe, with healthcare professionals across multiple disciplines recognising its potential to reduce costs and waiting times, and improve the patient experience.
About Acurable
Acurable is a fast-growing medical devices company with offices in London and Seville.
Acurable creates accurate and user-friendly wearable medical devices intended to be used by patients themselves at home.
Its award-winning, patented AcuPebble technology enables the automated diagnosis and management of respiratory conditions at home. It builds on the foundation of more than 10 years’ research at the Wearable Technologies Lab in Imperial College London, by Acurable’s founder, Professor Esther Rodriguez-Villegas.
Acurable is backed by investors from Alma Mundi Ventures and Kindred Capital. For more information, please visit www.acurable.com.
About Obstructive Sleep apnoea (OSA)
OSA is the third most common serious respiratory disorder, affecting up to 24% of adults and up to 5% of children (approximately 1 billion people globally). The condition causes sufferers to repeatedly stop breathing while they are asleep, usually due to obstruction of the airway. If left untreated, OSA can lead to serious health implications including high blood pressure, heart attack, type 2 diabetes and dementia. It is also the cause of 25% of road accidents due to tiredness. Due to the high long-term costs associated with these comorbidities, several studies have demonstrated that early diagnosis and treatment of OSA is cost-effective and could save the NHS up to £55m per year.
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