Sibel Health Advances Digital Health Innovation with FDA Recognition for Cough and Scratch Monitoring Technologies
核心洞察
Sibel Health (搜索) received FDA acceptance into the Drug Development Tool Qualification Program for its Aria cough monitoring sensor, marking the company's third FDA DDT acceptance alongside previous approvals for scratch and swallow sensors.
The company was awarded a $500,000 FDA grant to advance its ADAM™ scratch sensor for atopic dermatitis (搜索), building on technology that already demonstrates >99% accuracy in detecting scratch duration and events.
Sibel Health (搜索) now holds 3 out of 8 digital health technologies ever accepted into the FDA's rigorous DDT program, positioning the company as a leader in objective digital endpoints for clinical trials.
Sibel Health (搜索) has achieved significant regulatory milestones with the FDA recognizing two of its innovative wearable sensor technologies for drug development applications. The Chicago-based digital health company received FDA acceptance into the Drug Development Tool (DDT) Qualification Program for its Aria cough monitoring sensor while simultaneously securing a $500,000 grant to advance its ADAM™ scratch sensor for atopic dermatitis (搜索) trials.
FDA Recognizes Cough Monitoring Innovation
The Aria sensor (搜索) represents Sibel Health (搜索)'s third FDA DDT acceptance, following previous approvals for scratch sensor technology (DDT COA #000120) and a swallow sensor for Parkinson's disease (搜索) (DDT COA #000165). This achievement places Sibel Health as the developer of 3 out of 8 digital health technologies ever accepted into the FDA's rigorous DDT program as of February 2026.
The Aria sensor (搜索) 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.
"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 (搜索).
Addressing Chronic Refractory Cough
Chronic refractory cough (搜索) (CRC) affects up to 7 million adults annually in the U.S., significantly impacting quality of life through sleep disruption, social isolation, and emotional distress. The condition is defined as a persistent cough lasting more than 8 weeks that remains resistant to conventional treatment, primarily affecting adults over 50 years of age.
Current clinical trial endpoints rely heavily on subjective patient-reported outcomes such as patient diaries and recall-based questionnaires, which are prone to inaccuracies, recall bias, and variability. 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.
Scratch Sensor Technology Advances
Simultaneously, Sibel Health (搜索) received a $500,000 Drug Development Tools Research Grant from the FDA for its ADAM™ sensor technology targeting atopic dermatitis (搜索). The sensor addresses a critical gap in measuring itch, the defining symptom of atopic dermatitis that disrupts sleep, impairs daily function, and contributes to skin damage.
"We already have >99% accuracy in determining scratch duration and scratch events. Using Sibel Health (搜索)'s latest hardware innovations, we will be expanding upon our best in class scratch detection AI model using sensor fusion to estimate scratch intensity and the percentage of body surface area scratched," says Dylan Richards, Head of Data Science at Sibel Health and co-investigator.
The technology builds on a strategic partnership with Maruho Co., Ltd., a leading Japanese dermatology company. Earlier in 2025, a collaborative team demonstrated that a bio-feedback enabled version of the ADAM™ sensor reduced scratch events by 50% overnight in a cohort of atopic dermatitis (搜索) patients, with results published in JAMA Dermatology.
Clinical Impact and Future Applications
The implications of these technologies extend beyond their primary indications. While the FDA-supported scratch sensor work focuses on atopic dermatitis (搜索), applications extend to chronic kidney disease (搜索)–associated pruritus, cholestatic itch, prurigo nodularis (搜索), and infectious diseases like scabies.
For cough monitoring, the technology has potential applications in respiratory conditions including asthma (搜索), chronic obstructive pulmonary disease (COPD (搜索)), idiopathic pulmonary fibrosis (搜索) (IPF), and post-infectious cough, potentially accelerating therapy development for millions of patients.
"This is about more than technology," said Dr. Xu. "Itch is devastating. This is about giving patients, clinicians, and drug developers a common, objective vital sign for itch—one that reflects lived experience, not just recalled symptoms."
The Aria sensor (搜索) enables continuous, objective monitoring while protecting patient privacy through 24-hour data collection with wireless charging and mobile device connectivity, reducing patient and researcher burden through automated detection algorithms. Following FDA acceptance, Sibel Health (搜索) will advance to the next phase by submitting a comprehensive Qualification Plan for the cough monitoring technology.