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Smartphone-only cough counter application approved as a medical device in Australia and Europe
Technology already in use by a global pharmaceutical company to monitor disease in a clinical trial
Discussions on-going with customers for use in clinical research and monitoring disease progression in patient support and management programs
Brisbane, Australia, 29 November 2021 - ResApp Health Limited (ASX:RAP), a leading digital health company developing smartphone applications for the diagnosis and management of respiratory disease, is pleased to advise that it has achieved Australian Therapeutics Good Administration (TGA) clearance and CE Mark certification for the world's first regulatory-approved standalone cough counter smartphone application. The application is now listed on the Australian Register of Therapeutic Goods (ARTG) and available for sale in Europe as a class I medical device.
ResApp's standalone cough counter application tracks cough frequency using only a smartphone. The application uses ResApp's proprietary machine learning algorithms to accurately identify cough events from audio recorded using the smartphone's in-built microphone.
Cough frequency is a key factor in determining and managing respiratory disease progression and may also be a valuable outcome measure in clinical trials involving a broad range of disease states where cough is implicated. Traditionally, the only ways to measure the cough frequency is by subjective self-reporting or manually listening to audio recordings. These methods are labour intensive, not cost effective and inaccurate. The cough counting application was developed to deliver patients, healthcare providers and researchers more accurate and reliable analysis for disease monitoring.
ResApp's cough counting technology is already being used by the global biopharmaceutical company AstraZeneca to monitor patients participating in a lung cancer clinical trial and an asthma management support program.
CEO and Managing Director, Dr Tony Keating said: "We are pleased to have secured regulatory clearance in Australia and Europe for our cough counting technology. The ability to measure cough frequency using only a smartphone is a highly scalable solution that has a number of broad clinical applications. After our success in partnering with AstraZeneca, we are particularly excited about the opportunity in supporting clinical trials, where cough can provide important insight into the progression of disease and efficacy of treatment."
About ResApp Health Limited
ResApp Health Limited (ASX: RAP) is a leading digital health company developing smartphone applications for the diagnosis and management of the 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 which allows consumers to self-assess their risk of sleep apnoea. Both products are CE Marked in Europe and TGA approved in Australia. For more information, please visit www.resapphealth.com.au.
ResApp Health Limited published this content on 29 November 2021 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 29 November 2021 22:00:04 UTC.