Get expert insights into cough science, monitoring and research
As new mechanism-based therapies emerge and the field continues to refine its endpoint strategies, objective, continuous cough monitoring represents a strategic quantitative approach to complement existing outcome measures in bronchiectasis.
“CDRH clearance is neither necessary nor sufficient for CDER to accept a cough monitor as a trial endpoint. The two run on independent tracks.”
FDA device marketing approval and clinical trial endpoint acceptability are different issues. Equating the two may confuse sponsors about risks involved.
A decentralized feasibility study that delivered rich, real-world cough data without the scale, cost, or complexity of a trial or a market-research program.
Idiopathic Pulmonary Fibrosis (IPF) is a severe, chronic lung disorder characterized by progressive scarring of lung tissue, affecting millions worldwide. This disease significantly impacts quality of life, and its hallmark symptom is a persistent, nonproductive cough, which is crucial for early detection and monitoring disease progression.
IPF poses substantial economic burdens due to its high mortality rate and the complexity of its management, underlining the need for early detection and targeted management strategies.
Hyfe (www.hyfe.ai) builds software that detects coughing via audio analysis on phones, watches, wearables, and other devices with mics. Cough detection is fully automated, using AI algorithms trained on the sounds of coughs of tens of thousands of individuals. Since the system runs fully on-device, no audio data is sent to servers, thereby ensuring full patient privacy. By using Hyfe’s technology to detect and quantify cough, healthcare organizations seeking to roll out or improve COPD remote patient monitoring can improve outcomes and cut costs.
