Sibel Health Secures Third FDA Tool Qualification Acceptance With Aria Cough Sensor

New updates have been reported about Sibel Health.

Sibel Health has received U.S. Food and Drug Administration acceptance of its Letter of Intent for the Aria cough monitoring sensor into the agency’s Drug Development Tool Clinical Outcome Assessment Qualification Program, positioning the device as a potential standard endpoint for chronic refractory cough drug trials. This is Sibel’s third digital health technology in the DDT COA program, giving the company 3 of the 8 accepted digital tools to date and reinforcing its regulatory credibility in digital endpoints.

The Aria sensor is a neck-worn, suprasternal patch that captures acousto-mechanical signals from the body to quantify coughs in real time while excluding voice frequencies, enabling objective, privacy-preserving monitoring in clinic and at home. Coupled with an AI algorithm that automates cough detection and removes the need for manual labeling, the system targets a large unmet need in trials for chronic refractory cough, a condition affecting an estimated 7 million U.S. adults and currently measured largely by subjective patient diaries and labor-intensive audio review.

The FDA’s response explicitly recognized objective cough frequency as a key outcome measure for adult chronic refractory cough drug development and noted that automated tools not requiring ongoing manual review would be highly beneficial, effectively validating Sibel’s development path. Building on earlier FDA acceptances for its scratch sensor in atopic dermatitis and swallow sensor in Parkinson’s disease, and more than $1 million in cumulative FDA grant funding for digital endpoints, Sibel now has a differentiated portfolio of investigational tools that can be deployed across multiple therapeutic areas.

Next, Sibel will submit a detailed Qualification Plan for Aria, outlining validation studies needed to achieve full qualification as a drug development endpoint. If successful, Aria could become a de facto measurement standard in chronic cough trials and later in broader respiratory indications such as asthma, COPD, idiopathic pulmonary fibrosis, and post-infectious cough, deepening Sibel’s role as a key infrastructure provider to pharmaceutical sponsors and expanding the commercial potential of its digital sensor and analytics platforms.