CE Mark Awarded to AI-Powered Cough Monitoring Solution

C-mo Medical Solutions has received CE Mark certification for the C-mo System, its artificial intelligence (AI)-powered, non-invasive cough monitoring solution. The certification covers the biosensor, the automated cough-monitoring algorithms, and the software platform.

Designated a Class IIa medical device, the C-mo System objectively measures cough frequency, cough bouts, and cough intensity, and is used in pediatric, adult, and elderly patient populations (i.e. patients ages 5 and older).

The milestone marks an important step in the company’s commercial development and supports broader adoption of its privacy-preserving technology in both clinical trials and medical practice, executives claim.

“This important regulatory milestone reinforces confidence in the quality, safety and performance of our technology,” C-mo Medical Solutions CEO Diogo Tecelão said. “We believe C-mo can set a new standard for objective assessment of cough by enabling precise monitoring of cough across its different dimensions. With CE Mark now in place, we are well positioned to support pharmaceutical companies, researchers, and healthcare professionals in clinical trials and in medical practice.”

Building on its ISO 13485 certification, the CE Mark further reinforces C-mo’s commitment to meeting high regulatory and quality standards. To date, C-mo System has been validated in more than 180 subjects in three clinical studies, demonstrating a 95% median sensitivity and a 99.9% median specificity in cough event detection, with consistently strong performance across age groups, diseases, cough rates, and BMI.

C-mo System combines a wearable biosensor, AI-driven cough analysis, and an intuitive digital platform. The technology provides a comprehensive, unbiased and privacy-preserving approach to next-generation cough monitoring, enabling pharmaceutical companies, CROs, researchers, and healthcare providers to assess cough with clinical precision, according to the company. Unlike conventional cough monitoring systems, C-mo System is designed to generate precise, longitudinal cough data and clinically meaningful endpoints without recording private conversations.

Respiratory diseases are a growing healthcare challenge, driven by a substantial unmet need in diagnosis, available treatments, disease monitoring and long-term management. Chronic cough further adds to this burden, affecting approximately 9.6% of adults worldwide and carrying a substantial personal and healthcare burden.¹ It is associated with substantial impairment in quality of life, including sleep disruption, anxiety and depression, as well as repeated healthcare utilization and high resource burden. Chronic cough is a key symptom in several diseases, including refractory chronic cough, idiopathic pulmonary fibrosis (IPF), COPD, asthma, gastro-oesophageal reflux disease (GERD) and cystic fibrosis.

C-mo’s initial commercial focus is the clinical trials market, where pharmaceutical companies, biotechs and research institutions are increasingly seeking robust and objective cough endpoints. At the same time, the approval also supports future adoption in medical practice and hospital settings.

“In recent years, precise and reliable cough analysis has emerged as an important biomarker in respiratory research,” stated Prof. Surinder Birring, a consultant respiratory physician at King’s College Hospital in London. “However, only a few solutions are currently capable of delivering accurate cough monitoring suitable for everyday clinical use. The validation results generated with the C-mo System show that cough can be assessed objectively across multiple key dimensions, including frequency and intensity, while maintaining strong performance across diverse patient characteristics. This is particularly relevant for clinical trials, where robust and reproducible endpoints are essential. With CE Mark approval, an important step has been taken towards making C-mo widely available for clinical use.”

C-mo Medical Solutions has developed its product as a new benchmark for objective cough assessment, bringing digital precision to an area of care that has long relied on subjective reporting or limited objective tools.

C-mo Medical Solutions is a medtech company developing solutions that improve respiratory care. Its mission is to address a significant unmet need in monitoring and managing cough, an important clinical symptom and biomarker across multiple respiratory and other medical conditions. The Company’s C-mo System is a next-generation cough monitoring platform designed for modern clinical trials and use in medical practice. C-mo System is reportedly the first solution to combine objective measurement of cough frequency and cough intensity while avoiding the recording of private conversations. C-mo Medical Solutions is backed by various investors including Boehringer Ingelheim Venture Fund, High-Tech Gründerfonds, Novalis, and Portugal Ventures.

Reference
¹ Satia I et al. The Clinical Approach to Chronic Cough. J Allergy Clin Immunol Pract. 2025;13(3):454–466.  Bali V et al. Understanding the economic burden of chronic cough: a systematic literature review. BMC Pulm Med. 2023;23:430.