ResApp Health Ltd, a digital health company developing smartphone applications for the diagnosis and management of respiratory disease, has submitted its CE Mark Technical File to its European Notified Body, the British Standards Institution (BSI), for a smartphone application for the diagnosis of acute pediatric respiratory disease. 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, and bronchiolitis in infants and children. CE Marking will enable the commercial sale of ResAppDx-EU in the European Economic Area and facilitate commercialization in other markets such as Australia, Canada, and Singapore.
“The preparation and filing of the CE Mark Technical File for ResAppDx-EU, our flagship acute respiratory disease diagnostic tool, is an exciting moment for ResApp as it unlocks the last element required to commercialize our first product,” says Tony Keating, CEO and managing director, in a release. “Europe represents a very attractive opportunity with a large portion of the continent’s 6 billion annual general practitioner visits related to respiratory disease. ResAppDx-EU will provide clinicians with the first rapid and accurate test for the most commonly-seen acute respiratory diseases. It has the potential to have far-reaching benefits for the healthcare system and we are working with a German private hospital network this European winter to quantify these benefits.”
ResApp plans to file a de novo premarket submission for its acute pediatric respiratory disease diagnostic smartphone application with the US Food and Drug Administration in the first quarter of this calendar year.
ResApp has two other major clinical programs underway: an acute adult respiratory disease diagnosis study in which clinical adjudication is expected to finish this quarter and an at-home obstructive sleep apnea study in which recruitment is nearly complete. A technical issue prevented clinical adjudication for croup in ResApp’s acute pediatric respiratory disease diagnosis study in the US, SMARTCOUGH-C-2; however, this has been resolved and adjudication is expected to be completed this quarter.