Digital health company ResApp Health has submitted an application to the Food and Drug Administration (FDA) for De Novo classificiation of ResAppDX-US, a mobile software application for the diagnosis of paediatric respiratory disease using cough sounds.
ResAppDx-US is intended to be used by clinicians as an aid in the diagnosis of primary upper respiratory tract disease, lower respiratory tract disease and asthma or reactive airway disease. ResAppDx-US has the potential to improve diagnostic accuracy, shorten time to treatment and improve access to diagnostic testing, all using only a smartphone. The De Novo application is supported by the Smartcough-C-2 clinical study which recruited over 1,400 patients at three hospital sites in the US.
Tony Keating, CEO and managing director of ResApp Health said: “This submission represents the culmination of years of development work and marks a significant milestone towards commercialisation. These respiratory diseases are the most common illnesses seen in healthcare, and once cleared by the FDA ResAppDx-US will deliver substantial clinical benefits by providing actionable information to clinicians sooner. We are now entering a new and exciting phase in ResApp’s evolution as we prepare for the commercial launch of ResAppDx-US.”