- ResApp (RAP) receives 510(k) clearance from the US Food and Drug Administration (FDA) for its at-home sleep test, SleepCheckRx
- The test is listed as a prescription-only software-as-a-medical device and gaining FDA clearance will enable the company to commercially market the test in the US
- The sleep test will be made available to patients via a prescription from their healthcare provider which patients will be provided with a specific code allowing them to download the test from the Apple App Store and upload their results to a healthcare provider portal
- The app is only available on Apple devices but the company plans to solicit 501(k) clearance for Android devices in the future
- Shares in ResApp are down 3.7 per cent to trade at 13 cents as of 11:30 am AEST
ResApp (RAP) has received 510(k) clearance from the US Food and Drug Administration (FDA) for its at-home sleep test, SleepCheckRx.
The test is listed as a prescription-only software-as-a-medical device and gaining FDA clearance will enable the company to commercialise the test in the US.
SleepCheckRx is an easy-to-use, at-home sleep test that screens adults for the risk of moderate to severe obstructive sleep apnoea. It does this by analysing breathing and snore sounds recorded on an Apple iPhone.
ResApp plans to solicit 510(k) clearance for Android devices in the future.
CEO and Managing Director Tony Keating said the clearance unlocks a significant market opportunity for ResApp.
“With more than 20 million American adults suffering from sleep apnoea, the majority of those [do not know] that they have the condition.
“By using SleepCheckRx, physicians will have the opportunity to screen their patients conveniently and quickly for sleep apnoea, helping their patients take the first step to getting treatment.”
The sleep test 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 the test from the Apple App Store, with their results uploaded to a healthcare provider portal.
In an at-home clinical trial of 220 patients comparing SleepCheckRx to simultaneous
polysomnography, the test algorithms correctly identified 89.3 per cent of patients with
moderate to severe obstructive sleep apnoea and achieved a specificity of 77.6 per cent.
Shares in ResApp were down 3.7 per cent to trade at 13 cents as of 11:30 am AEST.