United Kingdom-based medical device company Acurable will launch its AcuPebble device for obstructive sleep apnea diagnosis in the United States this summer after recently securing a new US Food and Drug Administration (FDA) clearance

The patient-friendly device, which first launched in Europe in 2021, makes remote and efficient home sleep apnea testing possible, allowing for earlier detection, faster treatment, and better management of this chronic condition, according to a release from Acurable. AcuPebble extracts respiratory biomarkers continuously and accurately, enabling automated analysis.

To use the device, a patient attaches the sensor to the front of their neck before going to sleep. 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 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.

Due 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 (approximately 1%), according to a release from the company. 

The EU version of the device has been used by the National Health Service in the UK 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 polygraphy (94% positive predictive value, 98% negative predictive value, with positive and negative likelihood ratios over 10 and below 0.1, respectively). In this study, 100% of patients completed the test successfully without training or assistance beforehand.

In the US, Acurable plans to launch the FDA-cleared version of its device, adapted to target the specific needs of the US healthcare system. This follows the company’s recent $12 million Series A funding round. The most recent FDA-cleared device, AcuPebble Ox100, provides a complete sleep report and offers a comprehensive set of channels including, among others, heart rate and signals, activity, snoring, oxygen saturation, respiratory phases, and airflow.

Moreover, the device is comfortable to wear and allows the patient to have a fully natural, unconstrained, sleep at home. This provides reliable OSA diagnostic results and facilitates other clinically useful applications, such as multinight testing or monitoring of the evolution of the condition, according to a release from the company.

“Launching our device in the US 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,” says Esther Rodriguez-Villegas, inventor of the AcuPebble technology, founder and co-CEO of Acurable, in a release. “We have already had a lot of interest from US 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.” 

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,” says Michael Harrison, MD, founder of Magnap and professor of surgery and pediatrics at the Children’s Hospital at UCSF, in a release. “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.”

Photo caption: A man sleeps while wearing Acurable’s AcuPebble device.

Photo credit: Acurable