- ResApp has received Australian Therapeutics Goods Administration approval for its ResAppDx-EU device
- The device is now listed on the Australian Register of Therapeutic Goods
- ResAppDx-EU is now pending De Novo classification for paediatric use in the United States
ResApp is up more than 11 per cent this afternoon after receiving Australian Therapeutics Goods Administration (TGA) approval for its ResAppDx-EU device.
Just recently, the device received CE Mark approval for version 2 of the app, which comes after the original version of ResAppDx-EU received CE Mark certification as a Class IIa medical device.
ResAppDx-EU is a mobile software application to be used by clinicians for the diagnosis of lower respiratory tract disease, croup, pneumonia, asthma, and bronchitis in infants and children.
The software uses machine learning algorithms that analyse a patient’s cough sounds to diagnose disease and provide timely and accurate information.
It is a software-only solution that runs on a smartphone and does not require any additional hardware or accessories.
This recent approval classes ResAppDx-EU as a Class IIa medical device, and it is now listed on the Australian Register of Therapeutic Goods (ARTG).
According to ResApp, most people will develop an acute respiratory tract infection every year and these infections are the most common acute illnesses seen in primary care.
In Australia, upper respiratory tract infections account for 3-4 million visits to GPs every year. Lower respiratory tract infections cause an additional three million visits.
It is hoped that ResApp’s device will minimise the time, money, and effort spent diagnosing infections.
“Achieving TGA approval is an important regulatory milestone that allows us to sell ResAppDx-EU in Australia, our home market,” CEO and Managing Director Tony Keating said.
“We believe that ResAppDx-EU will deliver strong health and economic benefits when used by clinicians in Australian emergency departments, urgent care clinics, GP offices and in the Australian telehealth industry, which has grown markedly in the last year,” he continued.
ResAppDx-EU is now pending De Novo classification for paediatric use in the United States with a follow-on TGA submission for adult use will be made shortly.
ResApp shares are up 11.1 per cent at 2:33 pm AEST trading for $27.5 cents apiece. Its market cap is valued at $171.9 million.