On July 6, 2022, ResApp Health Limited announced that SleepCheckRx received FDA 510(k) clearance as prescription-only software as a medical device. It is intended to record respiratory patterns during sleep to pre-screen patients for obstructive sleep apnea (OSA).
About SleepCheckRx
SleepCheckRx is an at-home sleep test that screens adults for the risk of moderate to severe OSA by analyzing breathing and snoring sounds recorded on an Apple iPhone. The results can be used to assist health care professionals in determining the need for further diagnosis and evaluation.
The SleepCheckRx app is accessed via a compatible smartphone and uses the device’s microphone to record breathing and snoring sounds while the patient is asleep over a minimum duration of six hours. The audio recording is analyzed to provide a risk assessment of the presence of OSA.
In the app, the patient is instructed to enter basic information, such as birthdate, sex, height, weight and neck circumference and answer a STOP-BANG questionnaire. At bedtime, the patient places the phone on a nightstand and initiates recording.
The app is available to patients by prescription. Patients are issued a code allowing them to download the SleepCheckRx and their results are uploaded to a health care provider portal.
According to ResApp Health’s press release, the company plans to pursue FDA 510(k) clearance for Android devices in the future.
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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