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ResApp (ASX:RAP) receives TGA approval for ResAppDx-EU version 2

Health Care
ASX:RAP
20 February 2020 14:37 (AEST)
ResApp Health (ASX:RAP) - Managing Director & CEO, Tony Keating

Sourced: Finance News Network

ResApp (RAP) has received Australian Therapeutic Good Administration (TGA) approval for its ResAppDx-EU version 2 smartphone app.

The TGA approval is an extension of the existing approval for ResAppDx-EU, adding the ability to test adults for lower respiratory tract disease, pneumonia, asthma and chronic obstructive pulmonary disease.

Most people will develop an acute respiratory tract infection every year and thus are the most commonly seen in primary care.

Currently, diagnosis of these conditions is a complex, subjective process that combines clinical judgement with diagnostic aids such as imaging, and blood and phlegm tests.

ResAppDx-EU is ResApp’s mobile software application that is used by clinicians for the diagnosis of multiple respiratory problems and, up until today, was only available to children and infants.

The software uses machine learning algorithms that analyse a patient’s cough sounds to diagnose diseases and provide timely and accurate information.

It is a software-only solution that runs on smartphones and does not require and additional hardware or accessories.

“We are pleased that our lead product, ResAppDx-EU is now approved for use on both adults and children in Australia and Europe,” CEO and Managing Director Tony Keating commented.

“ResAppDx-EU offers strong health and economic benefits to Telehealth providers, emergency departments and urgent care clinics in Australia and Europe, and we are excited by the scale of the opportunity and our unique position in the market,” he added.

ResAppDx-EU is now listed on the Australian Register of Therapeutic Goods (ARTG) as a Class IIa medical device which means the device requires stricter regulatory controls to provide assurance of its effectiveness and safety.

After entering a trading halt yesterday, ResApp’s share price is currently trading for 24 cents apiece in a $167.1 million market cap.

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