– ResApp awarded second CE mark for its first smartphone-based diagnostic test for respiratory disease.
– 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.
– ResAppDx-EU version 2 is a software-only solution that runs on a smartphone and does not require any additional hardware or accessories.
ResApp Health Ltd., the Australian digital health company developing smartphone applications for diagnosis and management of respiratory disease announced that they have received a second CE Mark approval for ResAppDx-EU version 2. This version is one that can diagnose adult respiratory disease from the sound signatures of an individual’s cough. Last month ResApp received CE Mark approval for its pediatric software.
What That CE Mark Means for ResApp
This 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. 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.
ResApp’s Cough-based Diagnostic Algorithms
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 judgment 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 pediatric 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 analyze 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.
Why It Matters
“Achieving CE Mark approval allows us to commercialize 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,” said Tony Keating, CEO and Managing Director of ResApp. “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.”
