ResApp Health Limited announced that it has received notification from the Australian Therapeutics Goods Administration (TGA) that its smartphone application, ResAppDx-EU version 2, which diagnoses respiratory disease in both adults and children, is approved as a Class IIa medical device and is now listed on the Australian Register of Therapeutic Goods (ARTG). 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 exacerbation and chronic obstructive pulmonary disease (COPD) exacerbation. Most people will develop an acute respiratory tract infection every year and such infections are the most common acute illnesses seen in primary care. Currently, diagnosis of acute respiratory disease is a complex, subjective process, combining clinical judgement with diagnostic aids such as auscultation with a stethoscope, imaging, blood and sputum tests. ResAppDx-EU is a mobile software application to be used by clinicians for the diagnosis of lower respiratory tract disease, croup, pneumonia, asthma/reactive airway disease exacerbation, COPD exacerbation and bronchiolitis. The software uses machine learning algorithms that analyse a patient's cough sounds to diagnose disease. ResAppDx-EU is a software-only solution that runs on a smartphone and does not require any additional hardware or accessories.