FDAnews
www.fdanews.com/articles/192936-australia-approves-smartphone-diagnostic-for-acute-pediatric-respiratory-disease
Grey Approved Stamp

Australia Approves Smartphone Diagnostic for Acute Pediatric Respiratory Disease

October 2, 2019

Australia’s Therapeutic Goods Administration (TGA) has approved ResApp’s ResAppDx-EU, a smartphone-based app for diagnosing and managing respiratory disease in pediatric patients.

The app previously received the CE Mark, which was supported by data from a pediatric clinical study showing that the app’s cough-based diagnosis algorithms had “excellent agreement with a clinical diagnosis,” the company said.

The mobile software app is intended for use by clinicians to diagnose lower respiratory tract disease, croup, pneumonia, asthma/reactive airway disease and bronchiolitis in infants and children.

View today's stories