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.