Mobile app that uses cough sounds for diagnosis submitted for FDA approval

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.”

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