By: IPP Bureau
Last updated : April 16, 2026 3:43 pm
The CE Mark builds on the company’s ISO 13485 certification, further strengthening confidence in the platform's safety, quality and performance
C-mo Medical Solutions has received CE Mark approval for its C-mo System, an AI-powered cough monitoring platform, marking a key regulatory milestone that could accelerate adoption across respiratory clinical trials and future hospital use.
The approval covers the company’s wearable biosensor, automated cough detection algorithms and software platform under EU MDR 2017/745 Class IIa standards.
The non-invasive device is designed to objectively track cough frequency, cough bouts and cough intensity in patients aged above five years across paediatric, adult and elderly populations.
Unlike conventional cough monitoring tools, the system generates longitudinal, privacy-preserving cough data without recording private conversations, positioning it as a next-generation digital biomarker solution for respiratory research and care.
The CE Mark builds on the company’s ISO 13485 certification, further strengthening confidence in the platform's safety, quality and performance.
In three clinical studies involving more than 180 participants, the system demonstrated a median sensitivity of 95% and specificity of 99.9% for cough event detection, with strong performance across age groups, disease conditions and BMI ranges.
C-mo said its immediate commercial focus will be the clinical trials market, where pharmaceutical companies, biotechs, CROs and researchers are increasingly looking for robust and reproducible cough endpoints in respiratory disease studies. The company expects the certification to strengthen momentum with pharma partners and eClinical providers, while also opening pathways for deployment in routine medical practice.
The opportunity is significant as chronic cough affects nearly 9.6% of adults globally, and remains a major symptom across diseases such as COPD, asthma, idiopathic pulmonary fibrosis, GERD and cystic fibrosis. Objective cough analysis is emerging as an increasingly valuable biomarker in respiratory R&D, particularly for precision endpoints in drug development.
Commenting on the milestone, Diogo Tecelão said the CE Mark positions the company to set a new benchmark in objective cough assessment for both research and clinical use. Surinder Birring added that the approval is an important step toward making accurate, multi-dimensional cough analysis widely available for everyday clinical care and trials.