Sibel Health has received acceptance from the US Food and Drug Administration (FDA) into the clinical outcome assessment (COA) qualification programme under the drug development tool (DDT) framework for its Aria cough monitoring sensor.
This development marks Sibel Health’s third FDA DDT COA acceptance, advancing technology for chronic refractory cough (CRC) measurement in adults.
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The company previously secured DDT COA acceptances for a scratch sensor targeting atopic dermatitis and a swallow sensor designed for Parkinson’s disease.
Sibel Health now accounts for three of eight digital health technologies accepted by the FDA DDT COA programme as of 12 February 2026.
The company recently received a $500,000 grant from the FDA to qualify its scratch sensor, increasing its total direct funding for digital endpoint development to over $1m.
The Aria sensor is Sibel Health’s latest wearable device. It attaches at the suprasternal notch and uses acousto-mechanical sensing for detecting and quantifying real-time cough events by capturing acoustic signatures and mechanical vibrations.
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By GlobalDataIt operates outside of audible voice frequencies, helping address privacy concerns associated with traditional audio monitors.
Coupled with an AI algorithm, the Aria sensor eliminates the need for manual cough event labelling.
Sibel Health CEO and co-founder Steve Xu said: “Receiving FDA acceptance into the DDT Qualification Programme represents a major step forward in our mission to provide clinicians and researchers with reliable, patient-friendly tools for measuring chronic cough.”
The Aria sensor provides continuous, privacy-conscious monitoring, minimises researcher workload through automated detection, and supports 24-hour data collection with wireless charging and mobile connectivity.
Sibel Health will now submit a comprehensive qualification plan as part of the next phase of FDA review.
Upon successful qualification, Aria may serve as an endpoint in clinical trials for CRC treatments. Its technology may also be applied to other respiratory conditions such as chronic obstructive pulmonary disease (COPD), asthma, post-infectious cough, and idiopathic pulmonary fibrosis (IPF).
In March 2025, Sibel Health secured $30m in an equity financing round to expedite the commercial deployment of its Anne One monitoring platform.
