AcuPebble HSAT Receives FDA Clearance

acurable acupebble

Following a successful launch in Europe, medical device company Acurable is aiming to revolutionize sleep apnea detection for Americans with the launch of its AcuPebble device for obstructive sleep apnea (OSA) diagnosis in the U.S.

The extremely patient-friendly device makes remote and efficient home sleep apnea testing possible, allowing for earlier detection, faster treatment and better management of this chronic condition.

OSA affects around 25 million adults in the U.S.1 and causes people to repeatedly stop breathing while asleep. If left untreated, it is associated with serious health conditions, including heart attacks, diabetes and dementia.

Despite its prevalence, an estimated 85% of adults worldwide2 are undiagnosed and the current testing process is complex and expensive. Currently, patients need to visit a hospital so they can be trained to use the testing equipment, which involves using a set of uncomfortable wired sensors at home.

Around 10-20%3 of these sleep tests have to be repeated because sensors get detached or are not placed correctly by the patient. Once the results are available, a specialist needs to spend up to two hours manually interpreting the signals.

The AcuPebble device offers a much cheaper, faster, safer, environmentally-friendly, and patient-friendly solution. AcuPebble is the world’s first medical device that is able to extract respiratory biomarkers continuously and accurately, enabling automated analysis.

To use the device, all a patient needs to do is attach the sensor to the front of their neck before going to sleep. The sensor transfers the signals to a mobile device, which uploads the data to a secure platform. A doctor then receives a report with a diagnosis.

Thanks to the ease of use, no patient training or healthcare professional involvement is needed to explain how to use the device and very few tests have to be repeated (~1%). This means that sleep testing can be significantly scaled up while saving both clinicians’ and patients’ time. It also decreases infection risks by reducing patients’ need to visit a hospital.

The EU version of the device has been used by the National Health Service (NHS) in the U.K. as an established alternative to traditional testing processes for the past two years.

A study conducted at the Royal Free Hospital, a center of excellence in respiratory medicine in the UK, demonstrated the safety and effectiveness of AcuPebble against multi-channel polysomnography (94% positive predictive value, 98% negative predictive value, with positive and negative likelihood ratios over 10 and below 0.1, respectively).4 In this study, 100% of patients completed the test successfully without training or assistance beforehand.

Acurable plans to launch, in the summer, the FDA-cleared version of its device, adapted to target the very specific needs of the U.S. healthcare system. This follows their recent $12M Series A funding round, which was joined by KHP Ventures, the first NHS-anchored venture fund in the U.K.

The most recent FDA-cleared device, AcuPebble Ox100, provides a complete sleep report and offers a comprehensive set of channels including, amongst others, heart rate and signals, activity, snoring, oxygen saturation, respiratory phases and airflow.

Moreover, the device is very comfortable to wear and allows the patient to have a fully natural, unconstrained, sleep at home. This provides more reliable OSA diagnostic results and facilitates other clinically useful applications such as multi-night testing or monitoring of the evolution of the condition.

This breakthrough patented technology comes after a decade of research by Acurable’s founder, Professor Esther Rodriguez Villegas, at the Wearable Technologies Lab at Imperial College London. Ranked the 6th best university in the world, Imperial is a distinguished institution focusing solely on science, engineering, medicine and business.

AcuPebble has been recognized as a breakthrough in respiratory medicine, winning some of the most respected awards in the industry.

Acurable is predicting it will grow its team by 300% this year as it expands its business in the U.S.

“Launching our device in the U.S. is a major milestone for Acurable as we set our sights on AcuPebble becoming the gold standard and market leader for at-home sleep testing,” said Professor Esther Rodriguez-Villegas, inventor of the AcuPebble technology, Founder and Co-CEO of Acurable.

“We have already had a lot of interest from U.S. clinicians, who believe it can be transformational for the millions of Americans who have undiagnosed sleep apnea, putting them at risk of other serious health conditions. Yet accessing a diagnosis and the diagnostic test itself has for too long been uncomfortable and inconvenient for patients, and far too time-consuming for clinicians.

“The AcuPebble device is set to change that by making it far simpler for patients to get tested and for doctors to access the results, saving billions of dollars in the process.”

California-based Magnap has used the AcuPebble device in a sleep apnea clinical trial at the University of California San Francisco.

“The AcuPebble has been game-changing for our patients, as it is a much simpler and comfortable experience,” said Dr. Michael Harrison, Founder of Magnap and professor of surgery and pediatrics at the Children’s Hospital at UCSF for more than 20 years.

“It enables clinicians to conduct multiple night studies at a time, improving patient outcomes by giving them a much speedier diagnosis.

“This will make an enormous difference to the lives of millions of Americans who have undiagnosed sleep apnea.”


  1. American Academy of Sleep Medicine. Accessed April 2023.
  2. British Lung Foundation. Accessed April 2023.
  3. Validation of Embletta portable diagnostic system for identifying patients with suspected obstructive sleep apnoea syndrome (OSAS). Accessed April 2023.
  4. Provided by the NHS Royal Free Hospital (UK). Available from Acurable, AcuPebble SA100 clinical evidence. Accessed April 2023.

Source: Acurable

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