This represents Sibel Health's third FDA DDT COA acceptance, following previous acceptances for a scratch sensor for atopic dermatitis (DDT COA #000120) and a swallow sensor for Parkinson's disease (DDT COA #000165). Collectively, Sibel is responsible for 3 out of 8 digital health technologies ever accepted into the FDA's rigorous DDT COA program as of February 12th, 2026. Recently, Sibel announced winning a new $500,000 grant from the FDA to fully qualify its scratch sensor as an endpoint for atopic dermatitis bringing its direct funding from the FDA above $1 million total for digital endpoint development.
The Aria sensor, Sibel Health's latest wearable, adheres discretely to the suprasternal notch at the base of the neck, and uses advanced acousto-mechanic sensing to detect and quantify cough events in real-time. The device captures mechanical vibrations and acoustic signatures directly from the body while avoiding frequencies where voice is audible, addressing privacy concerns associated with traditional audio recording monitors. This approach enables continuous, objective monitoring in both clinical and home settings without capturing identifiable speech. With an accompanying AI algorithm for Aria, manual labeling is no longer required for determining cough events.
"Receiving FDA acceptance into the DDT Qualification Program represents a major step forward in our mission to provide clinicians and researchers with reliable, patient-friendly tools for measuring chronic cough," said Steve Xu, MD, FAAD, CEO and Co-Founder of Sibel Health. "Chronic refractory cough affects up to 7 million adults annually in the U.S., significantly impacting quality of life through sleep disruption, social isolation, and emotional distress. Our sensor technology offers an objective, privacy-conscious alternative to subjective patient diaries and labor-intensive manual counting methods," adds Benjamin Monteagudo, Senior Product Manager at Sibel Health.
Addressing a Critical Unmet Need
Chronic refractory cough is a persistent cough lasting more than 8 weeks that remains resistant to conventional treatment. Primarily affecting adults over 50 years of age, CRC often arises from multiple causes including postnasal drip, asthma, and gastroesophageal reflux disease (GERD). Studies have shown that frequent coughing interferes with sleep efficiency and wakefulness after sleep onset, with nocturnal coughing becoming one of the primary patient complaints. Beyond physical symptoms, CRC patients report significant social and emotional impacts, including stigma, isolation, and avoidance of public settings—concerns that were amplified during the COVID-19 pandemic.
Current clinical trial endpoints rely heavily on subjective patient-reported outcomes (PROs) such as patient diaries and recall-based questionnaires, which are prone to inaccuracies, recall bias, and variability. These subjective measures can be particularly unreliable in older adults, where cognitive decline may further compromise the accuracy of self-reported cough frequency and severity. Alternative methods involving time-consuming manual review of audio recordings require significant resources and trained personnel to review. The FDA, in its acceptance response to Sibel, identifies objective cough frequency as a key outcome measure for drug development programs targeting adult refractory chronic cough, noting that automated tools that do not require longitudinal review by trained personnel would be highly beneficial.
The Aria sensor addresses this gap by:
- Providing continuous, objective monitoring while protecting patient privacy
- Enabling 24-hour data collection with wireless charging and mobile device connectivity
- Reducing patient and researcher burden through automated cough detection algorithms leveraging AI
Following this acceptance, Sibel Health will advance to the next phase of the FDA qualification process by submitting a comprehensive Qualification Plan (QP). "This FDA acceptance validates the clinical need for our technology and provides a clear regulatory pathway forward," says Kevin Dwyer, Director of Regulatory Affairs and Quality Assurance at Sibel Health. "We're committed to conducting rigorous validation studies that will support the qualification of the Aria sensor as a reliable tool for drug development and, ultimately, clinical care."
Upon successful completion of the qualification process, the Aria sensor would be deployed as an endpoint in clinical trials evaluating new treatments for chronic refractory cough. Beyond CRC, the technology has potential applications in other respiratory conditions where objective cough measurement is clinically relevant, including asthma, chronic obstructive pulmonary disease (COPD), idiopathic pulmonary fibrosis (IPF), and post-infectious cough, potentially accelerating the development of therapies for millions of patients suffering from these debilitating conditions.
About Sibel Health
Sibel Health is an award-winning digital health company with a mission to deliver Better Health Data for All®. Based in Chicago with an international office in Seoul, the company's FDA-cleared ANNE® platform includes advanced wearable sensors, AI-enabled data analytics, and an integrated mobile software and cloud platform. The company's Discovery platform is used by the world's leading pharmaceutical companies for clinical trials. For more information, visit www.sibelhealth.com, follow us on LinkedIn, or contact us at [email protected].
About the FDA DDT Qualification Program:
The FDA's Drug Development Tool Qualification Program provides a pathway for medical device developers to gain regulatory acceptance of novel assessment tools that can be used across multiple drug development programs. Qualification demonstrates that a DDT is fit for a specific intended purpose in drug development.
Note: The Aria sensor is an investigational device and is not yet cleared or approved by the FDA for commercial use.
SOURCE Sibel Health
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