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FDA Greenlights Sibel Health's Cough Sensor Tech
20 Feb
Summary
- Sibel Health's Aria sensor accepted by FDA for COA qualification.
- Sensor uses acousto-mechanical sensing to quantify cough events.
- Aria may be used in clinical trials for chronic refractory cough treatments.
Sibel Health has achieved a significant milestone with its Aria cough monitoring sensor, securing acceptance into the US Food and Drug Administration's (FDA) clinical outcome assessment (COA) qualification program. This program operates under the drug development tool (DDT) framework, aiming to advance measurement technologies for various diseases.
The Aria sensor is a wearable device that attaches at the suprasternal notch. It employs acousto-mechanical sensing to detect and quantify real-time cough events by capturing acoustic signatures and mechanical vibrations. Operating outside audible voice frequencies, it addresses privacy concerns associated with traditional audio monitors.
This FDA acceptance is Sibel Health's third in the DDT COA program, highlighting its focus on digital health technologies. Previously, the company received acceptances for sensors targeting atopic dermatitis and Parkinson's disease. The Aria sensor, combined with an AI algorithm, eliminates the need for manual cough event labeling, reducing researcher workload.
Upon successful qualification, the Aria sensor may serve as an endpoint in clinical trials for chronic refractory cough (CRC) treatments. Its technology also holds potential applications for other respiratory conditions, including COPD, asthma, post-infectious cough, and idiopathic pulmonary fibrosis (IPF).
