Digital health company ResApp (ASX:RAP) has announced TGA clearance and CE Mark certification for its 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 said its standalone cough counter application tracks cough frequency using only a smartphone.
The application uses ResApp’s 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 way to measure the cough frequency is by subjective self-reporting or manually listening to audio recordings. These methods are labour intensive and inaccurate.
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.”