Digital health specialist ResApp Health Limited (ASX:RAP) has received the important CE Mark of approval for its ResAppDx-EU version 2, a smartphone-based diagnostic test for respiratory disease which now addresses both adults and children.
The CE Mark approval is an extension of the existing CE Mark 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.
Tony Keating, CEO and Managing Director of ResApp said the CE Mark certification indicates that ResAppDx-EU version 2 meets the essential requirements of all the applicable European regulations as a class IIa medical device and allows for its sale throughout the European Economic Area.
“Achieving CE Mark approval allows us to commercialise our novel smartphone-based test for diagnosing acute respiratory disease in adults and children across the European Economic Area as well as in other regions that recognise the CE Mark.
“A large percentage of general practitioner, emergency department and telehealth consultations are for respiratory disease and now, for the first time, clinicians in Europe will have access to a fast and accurate point-of-care diagnostic test that will improve care and reduce costs for patients of all ages.”
Mr Keating said most people will develop an acute respiratory tract infection every year and such infections are the most common acute illnesses seen in primary care.
“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.
ResApp’s cough-based diagnostic algorithms have been shown in pivotal clinical studies to accurately diagnose the most common adult and paediatric acute respiratory diseases when compared with a panel of experienced clinicians.”
ResAppDx-EU version 2 is a mobile software application to be used by clinicians for the diagnosis of lower respiratory tract disease, croup (in children only), pneumonia, asthma exacerbation/reactive airway disease, COPD exacerbation (in adults only) and bronchiolitis (in children only). The software uses machine learning algorithms that analyse a patient’s cough sounds to diagnose disease.
ResAppDx-EU version 2 is a software-only solution that runs on a smartphone and does not require any additional hardware or accessories.