C-mo Medical Solutions Receives CE Mark for AI-Powered Cough Monitoring System
Key Insights
C-mo Medical Solutions (search) has received CE Mark approval for its C-mo System (search), a Class IIa medical device that uses AI-powered algorithms to objectively monitor cough frequency, bouts, and intensity in patients aged 5 years and older.
The system demonstrated strong clinical validation with median sensitivity of 95.0% and specificity of 99.9% in cough event detection across more than 180 subjects in three clinical studies.
The technology addresses a significant unmet need in respiratory care, as chronic cough affects approximately 9.6% of adults worldwide and is associated with substantial quality of life impairment.
C-mo Medical Solutions (search) has achieved a significant regulatory milestone with the receipt of CE Mark approval for its C-mo System (search), an AI-powered cough monitoring solution that promises to transform how respiratory conditions are assessed in clinical trials and medical practice. The Class IIa medical device, now CE-marked under EU MDR 2017/745, offers objective monitoring of cough across a broad range of indications for patients aged 5 years and older.
Robust Clinical Validation Demonstrates High Accuracy
The C-mo System (search) has undergone extensive clinical validation, demonstrating impressive performance metrics across diverse patient populations. In three clinical studies involving more than 180 subjects, the technology achieved a median sensitivity of 95.0% and median specificity of 99.9% in cough event detection. The system maintained consistently strong performance across age groups, diseases, cough rates, and BMI variations.
The CE Mark certification covers the complete solution, including the biosensor, automated cough monitoring algorithms, and software platform. This comprehensive approval enables the system to objectively measure cough frequency, cough bouts, and cough intensity while preserving patient privacy by avoiding the recording of private conversations.
Addressing Critical Unmet Medical Needs
Respiratory diseases represent a growing healthcare challenge, with substantial unmet needs in diagnosis, treatment options, disease monitoring, and long-term management. Chronic cough compounds this burden, affecting approximately 9.6% of adults worldwide and carrying significant personal and healthcare costs. The condition is associated with substantial quality of life impairment, including sleep disruption, anxiety, and depression, as well as repeated healthcare utilization and high resource burden.
Chronic cough serves as a key symptom across multiple diseases, including refractory chronic cough, idiopathic pulmonary fibrosis (IPF), COPD, asthma, gastro-oesophageal reflux disease (GERD), and cystic fibrosis. The C-mo System (search)'s ability to provide precise, longitudinal cough data addresses the long-standing reliance on subjective reporting or limited objective tools in this critical area of respiratory care.
Technology Platform and Commercial Strategy
The C-mo System (search) combines a robust wearable biosensor with sophisticated AI-driven cough analysis and an intuitive digital platform. This integration provides a comprehensive, unbiased, and privacy-preserving approach to next-generation cough monitoring, enabling pharmaceutical companies, contract research organizations (CROs), researchers, and healthcare providers to assess cough with clinical precision.
"This important regulatory milestone reinforces confidence in the quality, safety and performance of our technology," said Diogo Tecelão, CEO of C-mo Medical Solutions (search). "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."
The company's initial commercial focus targets the clinical trials market, where pharmaceutical companies, biotechnology firms, and research institutions increasingly seek robust and objective cough endpoints. The approval simultaneously supports future adoption in medical practice and hospital settings.
Clinical Expert Endorsement
Prof. Surinder Birring, Consultant Respiratory Physician at King's College Hospital, London, emphasized the significance of the technology's validation. "In recent years, precise and reliable cough analysis has emerged as an important biomarker in respiratory research," he noted. "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 (search) show that cough can be assessed objectively across multiple key dimensions, including frequency and intensity, while maintaining strong performance across diverse patient characteristics."
Regulatory Foundation and Investment Support
Building on its ISO 13485 certification, the CE Mark further reinforces C-mo's commitment to meeting high regulatory and quality standards. The company maintains compliance with EU MDR 2017/745 and aligns with GDPR, HIPAA, and state-of-the-art cybersecurity standards.
C-mo Medical Solutions (search) has secured backing from leading investors including Boehringer Ingelheim Venture Fund (search), High-Tech Gründerfonds (search), Novalis (search), and Portugal Ventures (search). The CE Mark approval is expected to support the company's commercial momentum as it expands engagement with pharmaceutical partners, CROs, eClinical partners, researchers, and healthcare professionals.