ResApp Health’s SleepCheckRx app received FDA 510(k) clearance as a prescription-only software-as-a-medical device. Gaining FDA clearance enables ResApp to commercially market the test in the United States.
SleepCheckRx is an at-home sleep test that screens adults for the risk of moderate to severe obstructive sleep apnea by analyzing breathing and snore sounds recorded on an Apple iPhone.
The app requires no accessories or hardware other than an iPhone to make an assessment. ResApp plans to solicit 510(k) clearance for Android devices in the future.
ResApp Health is a digital health company developing smartphone applications for the diagnosis and management of respiratory disease. ResApp’s machine learning algorithms use sound to diagnose and measure the severity of respiratory conditions without the need for additional accessories or hardware.
ResApp’s regulatory-approved and clinically validated products include ResAppDx, a smartphone-based acute respiratory disease diagnostic test for use in telehealth, emergency department and primary care settings; and SleepCheck, a smartphone application that allows consumers to self-assess their risk of sleep apnea. Both products are CE Marked in Europe and TGA-approved in Australia.
SleepCheckRx will be made available to patients via a prescription from their healthcare provider. Patients will be provided with a specific code allowing them to download SleepCheckRx from the App Store, with their results uploaded to a healthcare provider portal.
According to the company, in an at-home clinical trial of 220 patients comparing SleepCheckRx to simultaneous polysomnography, the SleepCheckRx algorithms correctly identified 89.3% of patients with moderate to severe obstructive sleep apnea (AHI greater than or equal to 15/hour) and achieved a specificity of 77.6%.
Tony Keating, CEO and managing director of ResApp Health, says in a release, “We are delighted to have secured FDA clearance for SleepCheckRx. With more than 20 million American adults suffering from sleep apnea and the majority of those not knowing that they have the condition, this clearance unlocks a significant market opportunity for ResApp. By using SleepCheckRx, physicians will have the opportunity to screen their patients conveniently and quickly for sleep apnea, helping their patients take the first step to getting treatment.”