Strados Labs, a digital health company focused on improving the lives of patients with respiratory diseases, announced today the successful completion of a recent study of its technology in pediatric asthma, which took place at Ann & Robert H. Lurie Children’s Hospital of Chicago. The study focused on evaluating the clinical utility and effectiveness of the company’s technology, the RESP® Biosensor, in detecting wheezing in children.
The RESP® Biosensor, an innovative wearable device that remotely measures changes in lung sounds such as coughing and wheezing, has shown significant promise aiding in disease management in adult respiratory patients and received two FDA 510(k) clearances. This study was the company’s first study utilizing the device in children, a steppingstone towards the larger goal of assisting in the management pediatric asthma which affects 5 million children in the US each year (source).
The study, which was completed in late June, was led by Dr. Henry Schmidt and enrolled 35 patients. While Strados Labs is still preparing and analyzing full results from the study, initial feedback and results from the study were reported to be positive. These results were presented at the American Thoracic Society 2024 annual conference by Dr. David R. Spielberg which can be viewed here.
“We are thrilled to have completed our first pediatric study which is an important step towards bringing our technology to children and families,” Says Devan Parson, Clinical Operations Manager at Strados Labs. “Working with the team at Lurie Children’s has been a pleasure and we’re grateful for their support and partnership.”
Based on the results of the study, Strados Labs plans to submit for FDA clearance of the RESP® Biosensor for pediatric use in 2025.