On Nov. 30, 2021, Acurable announced it received FDA 510(k) clearance for its AcuPebble SA100, a small wearable device that enables automated, remote home testing to detect obstructive sleep apnea (OSA) in adults.
About AcuPebble SA100
AcuPebble SA100 senses, records and interprets a patient’s physiological signals during sleep for the purpose of prescreening patients for OSA. The device is designed for use in home-screening adults with suspected sleep breathing disorders.
A small, noninvasive sensor is attached to the base of the neck to record sounds generated by the patient’s respiratory and cardiac functions. The signals are transmitted to a mobile device and uploaded to a cloud platform. AcuPebble SA100 signal processing algorithms extract OSA diagnostic parameters, which can be accessed by a health care professional.
The system is not intended as a substitute for full polysomnography when parameters such as sleep stages, limb movements or EEG are required. It is not intended for use with patients with pacemakers, other implantable devices, or those with known or suspected arrhythmias.
About obstructive sleep apnea
OSA is a prevalent and serious sleep disorder where the airway becomes repeatedly blocked during sleep, leading to paused breathing and oxygen deprivation. Commonly caused by the collapse of throat tissues, it can result in loud snoring, choking noises and frequent awakenings, potentially contributing to health issues such as high blood pressure, heart disease, stroke, diabetes and depression.
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