Leading digital health company ResApp Health (ASX:RAP) has announced it has submitted an application to the US FDA for De Novo classification of its ResAppDx-US - a mobile software application for the diagnosis of paediatric respiratory disease using cough sounds.
Cough is one of the most common illness-related reasons for ambulatory visits in the US. It one of the top two principal reasons for children to visit a hospital emergency department (ED).
According to ResApp, the single most common diagnosis from a child’s ED visit is an acute upper respiratory tract infection, with lower respiratory tract diseases also among the most frequent diagnoses.
The company said its ResAppDx-US is for use by clinicians as an aid in the diagnosis of primary upper respiratory tract disease, lower respiratory tract disease and asthma/reactive airway disease.
It has the potential to improve diagnostic accuracy, shorten time to treatment and improve access to diagnostic testing, all using a smartphone.
The company said its De Novo application to the FDA is supported by the SMARTCOUGH-C-2 clinical study that recruited over 1,400 patients at three hospital sites in the US.
“This submission represents the culmination of years of development work and marks a significant milestone towards commercialisation,” said CEO and managing director Tony Keating.
“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.”