August 15, 2022

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ResApp Health : receives FDA 510(k) clearance for

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Brisbane, Australia, 6 July 2022 – ResApp Well being Limited (ASX:RAP), a primary electronic health corporation developing smartphone applications for the prognosis and administration of respiratory illness, is happy to announce that SleepCheckRx has acquired 510(k) clearance as a prescription-only software-as-a-health care device from the US Food and Drug Administration (Fda). Getting Fda clearance permits ResApp to commercially market place the take a look at in the United States.

SleepCheckRx is an simple to use, at-dwelling snooze check that screens grownups for the threat of average to intense obstructive sleep apnoea by analysing breathing and snore appears recorded on an Apple Apple iphone. It demands no equipment or hardware other than an Iphone to make an evaluation. ResApp options to solicit 510(k) clearance for Android equipment in the long term.

Snooze apnoea is the most frequent rest breathing dysfunction and impacts a lot more than three in each ten guys and nearly two in each and every 10 gals1. Obstructive slumber apnoea is when air stops flowing to the lungs all through snooze. The prevalence of slumber apnoea is rising due to an ageing population and escalating rates of weight problems. Experiments have demonstrated that up to 80% of men and women with snooze apnoea are undiagnosed and untreated2.

SleepCheckRx will be created available to sufferers by using a prescription from their healthcare company. Patients will be provided with a certain code letting them to down load SleepCheckRx from the App Shop, with their benefits uploaded to a health care service provider portal.

In an at-property scientific trial of 220 clients evaluating SleepCheckRx to simultaneous polysomnography, the SleepCheckRx algorithms correctly discovered 89.3% of individuals with average to severe obstructive rest apnoea (AHI bigger than or equivalent to 15/hour) and achieved a specificity of 77.6%.

Tony Keating, CEO and Handling Director reported: “We are delighted to have secured Food and drug administration clearance for SleepCheckRx. With a lot more than 20 million American grownups suffering from snooze apnoea and the vast majority of these not recognizing that they have the problem, this clearance unlocks a considerable market place chance for ResApp. By utilizing SleepCheckRx, medical professionals will have the opportunity to monitor their patients conveniently and swiftly for slumber apnoea, helping their sufferers consider the initially stage to finding treatment.”

1. Peppard et al., Growing prevalence of sleep-disordered respiration in grownups, Am J Epidemiol 177(9), 2013
2. Frost & Sullivan, Hidden Wellbeing Disaster Costing The us Billions

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About ResApp Health and fitness Confined

ResApp Well being Minimal (ASX: RAP) is a primary digital wellness corporation producing smartphone applications for the prognosis and administration of respiratory condition. ResApp’s equipment studying algorithms use seem to diagnose and measure the severity of respiratory problems with no the require for added add-ons or hardware. ResApp’s regulatory-authorized and clinically validated solutions contain ResAppDx, a smartphone-primarily based acute respiratory disease diagnostic check for use in telehealth, unexpected emergency division and major care configurations and SleepCheck, a smartphone software which makes it possible for shoppers to self-evaluate their hazard of snooze apnoea. Both products are CE Marked in Europe and TGA authorised in Australia. For more data, you should check out www.resapphealth.com.au.