Respiratory diagnostics company ResApp Health Ltd has received CE Mark approval for ResAppDx‑EU version 2, the latest version of its smartphone-based diagnostic test for respiratory disease—which now addresses both adults and children.
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. In August, ResApp received CE Mark approval for its pediatric software. 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 have been shown in 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.
“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 recognize the CE Mark,” says Tony Keating, CEO and managing director of ResApp, in a release. “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.”
ResApp has an at-home obstructive sleep apnea study underway.