FDA okays ResApp’s (ASX:RAP) SleepCheckRx; how are shares faring?

3 min read | July 06, 2022 01:12 PM AEST | By Aditi Sarkar

Google News:

FDA okays ResApp’s (ASX:RAP) SleepCheckRx; how are shares faring? — Image source: © Stockbakery | Megapixl.com

Recent News

ASX Alert: Stealth Global’s Forecast Sparks Market Buzz

ASX Opens Cautiously as Oil Slides and Key Stocks Make Headlines

Dow Hits Records While Oil Slides: What Could Shape the ASX Today?

Why Is Excite Technology Services Rewarding Staff With New Shares?

Make Kalkine Media
My Trusted Source

Highlights

ResApp Health receives the US Food and Drug Administration (FDA) clearance for its SleepCheckRx mobile application

SleepCheckRx is a sleep test that analyses the risk of moderate to severe obstructive sleep apnoea in adults by probing breathing and snore sounds recorded on an Apple iPhone

ResApp plans to seek 510(k) clearance for Android devices in the future

ResApp Health Limited (ASX:RAP), a digital health company, has received the US Food and Drug Administration (FDA) clearance for its at-home sleep test SleepCheckRx. This clearance opens a substantial market prospect for ResApp as over 20 million adults in America suffer from sleep apnoea. The company can now commercially sell the test in the United States.

SleepCheckRx is a sleep test (mobile application) that can be used at home. It analyses the risk of moderate to severe obstructive sleep apnoea in adults by probing breathing and snore sounds recorded on an Apple iPhone. It does not require any other accessories.

SleepCheckRx has got 510(k) clearance from FDA as a prescription-only software-as-a-medical device. ResApp plans to seek 510(k) clearance for Android devices in the future.

What is sleep apnoea?

Sleep apnoea is a very common sleep breathing disorder, and its prevalence is growing due to the increasing ageing population and increasing rates of obesity. The condition affects over three out of ten men and almost two out of ten women. Studies indicate that almost 80% of people with sleep apnoea are unaware of the condition and are untreated.

Obstructive sleep apnoea is a condition when the air stops flowing to the lungs during sleep.

Patients can avail SleepCheckRx through a prescription from their healthcare providers. A specific code will be given to them for downloading the application from mobile Appstore. Their results will be uploaded to the portal of the healthcare provider.

SleepCheckRx was assessed in 220 patients in an at-home clinical trial, compared to simultaneous polysomnography, which is a study designed to identify sleep disorders. The app’s algorithm correctly identified 89.3% of patients with moderate to severe sleep apnoea with a 77.6% specificity.

Australian and Japanese patents

Yesterday (05 July), the company bagged a patent entitled “Methods and apparatus for cough detection in background noise environments”. The patent was granted in Australia and Japan. It covers the use of machine learning audio processing techniques for detecting cough sounds in settings with considerable background noise.

Stock information

At the time of writing this article (as on WED 06 JUL at 11:51 AM AEST), shares of RAP were trading at AU$0.132.

Disclaimer

The content, including but not limited to any articles, news, quotes, information, data, text, reports, ratings, opinions, images, photos, graphics, graphs, charts, animations and video (Content) is a service of Kalkine Media Pty Ltd (Kalkine Media, we or us), ACN 629 651 672 and is available for personal and non-commercial use only. The principal purpose of the Content is to educate and inform. The Content does not contain or imply any recommendation or opinion intended to influence your financial decisions and must not be relied upon by you as such. Some of the Content on this website may be sponsored/non-sponsored, as applicable, but is NOT a solicitation or recommendation to buy, sell or hold the stocks of the company(s) or engage in any investment activity under discussion. Kalkine Media is neither licensed nor qualified to provide investment advice through this platform. Users should make their own enquiries about any investments and Kalkine Media strongly suggests the users to seek advice from a financial adviser, stockbroker or other professional (including taxation and legal advice), as necessary. Kalkine Media hereby disclaims any and all the liabilities to any user for any direct, indirect, implied, punitive, special, incidental or other consequential damages arising from any use of the Content on this website, which is provided without warranties. The views expressed in the Content by the guests, if any, are their own and do not necessarily represent the views or opinions of Kalkine Media. Some of the images/music that may be used on this website are copyright to their respective owner(s). Kalkine Media does not claim ownership of any of the pictures displayed/music used on this website unless stated otherwise. The images/music that may be used on this website are taken from various sources on the internet, including paid subscriptions or are believed to be in public domain. We have used reasonable efforts to accredit the source wherever it was indicated as or found to be necessary.