- Regulatory milestone supports broader adoption of C-mo’s privacy-preserving technology in clinical research and medical practice
- Approval covers the biosensor, automated cough monitoring algorithms and software platform
- C-mo allows precise, objective monitoring of cough frequency and intensity across multiple indications
LISBON, Portugal – April 15, 2026 – C-mo Medical Solutions, a leading provider of next-generation cough monitoring technology, today announced that it has received CE Mark for C-mo System, its AI-powered cough monitoring solution.
C-mo System is a non-invasive, Class IIa medical device, now CE-marked under EU MDR 2017/745, for monitoring cough in patients across a broad range of indications. The certification covers the biosensor, the automated cough monitoring algorithms and the software platform. This solution objectively measures cough frequency, cough bouts and cough intensity, and is indicated for use across pediatric, adult and elderly patient populations (i.e. any patients aged > 5 years old).
Strong clinical and regulatory validation support broader adoption
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.
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 median sensitivity of 95.0% and median specificity of 99.9% in cough event detection, with consistently strong performance across age groups, diseases, cough rates and BMI.
C-mo System combines a robust wearable biosensor, sophisticated 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. 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: Significant unmet medical need
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 burden1. 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.
Providing actionable insights for clinical trials and medical practice
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.
“This important regulatory milestone reinforces confidence in the quality, safety and performance of our technology,” said Diogo Tecelão, Chief Executive Officer of C-mo Medical Solutions. “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.”
“In recent years, precise and reliable cough analysis has emerged as an important biomarker in respiratory research,” said Prof. Surinder Birring, Consultant Respiratory Physician at King’s College Hospital, London, UK. “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.”
The CE Mark is expected to support the Company’s commercial momentum as it expands engagement with pharmaceutical partners, CROs, eClinical partners, researchers and healthcare professionals. C-mo has developed its solution 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.
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About C-mo Medical Solutions
C-mo Medical Solutions is a pioneering medtech company focused on developing innovative solutions that improve respiratory care. Its mission is to address a significant unmet need in the monitoring and management of 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. Combining a wearable biosensor, AI-powered algorithms and software, the platform delivers automated, scalable and privacy-preserving assessments of cough. C-mo System is 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 ISO 13485-certified, compliant with EU MDR 2017/745 and has a Class IIa CE-marked product. The Company is also aligned with GDPR, HIPAA and state-of-the-art cybersecurity standards.
C-mo Medical Solutions is backed by leading investors including Boehringer Ingelheim Venture Fund, High-Tech Gründerfonds, Novalis and Portugal Ventures.
Media Inquiries
C-mo Medical Solutions
Diogo Tecelão, Chief Executive Officer
press@c-mo.solutions
akampion
Ines-Regina Buth
Managing Partner
info@akampion.com
Tel. +49 30 23 63 27 68
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