C-mo Medical Solutions Secures CE Mark for Innovative AI-Powered Cough Monitoring System

• This regulatory achievement paves the way for wider use of C-mo’s privacy-protecting technology in both clinical research and healthcare delivery
• The clearance includes the biosensor, the automated cough monitoring algorithms, and the software platform
• The C-mo solution enables accurate, objective tracking of cough frequency and intensity for various medical conditions

(SeaPRwire) –   LISBON, Portugal – April 15, 2026 – C-mo Medical Solutions, a premier provider of advanced cough monitoring technology, today declared it has obtained CE Mark for its C-mo System, an AI-driven cough monitoring solution.

The C-mo System is a non-invasive, Class IIa medical device, now certified under EU MDR 2017/745, for tracking cough in patients with a wide variety of indications. The approval encompasses the biosensor, the automated algorithms for cough monitoring, and the software platform. This technology impartially quantifies cough frequency, cough bouts, and cough intensity, and is approved for pediatric, adult, and elderly patient groups (patients over 5 years old).

Robust clinical and regulatory validation facilitates wider use

This achievement represents a significant phase in the Company’s commercial growth and encourages the expanded implementation of its privacy-conscious technology in clinical studies and healthcare settings.

Complementing its ISO 13485 certification, the CE Mark further underscores C-mo’s dedication to adhering to stringent regulatory and quality benchmarks. Thus far, the C-mo System has been tested in over 180 participants across three clinical trials, showing a median sensitivity of 95.0% and a median specificity of 99.9% in identifying cough events, with reliably high performance regardless of age, disease, cough rates, or BMI.

The C-mo System integrates a durable wearable biosensor, advanced AI-based cough analysis, and a user-friendly digital platform. This technology offers a thorough, impartial, and privacy-conscious method for next-generation cough monitoring, allowing pharmaceutical firms, CROs, researchers, and healthcare providers to evaluate cough with clinical accuracy. In contrast to traditional cough monitoring systems, the C-mo System is engineered to produce accurate, long-term cough data and clinically relevant endpoints without capturing private speech.

Respiratory diseases: A major unmet healthcare challenge

Respiratory illnesses represent an escalating healthcare issue, fueled by a significant gap in diagnosis, treatment options, disease tracking, and long-term care. Chronic cough compounds this problem, impacting about 9.6% of adults globally and imposing a considerable personal and healthcare cost¹. It is linked to a major reduction in quality of life, involving sleep disturbances, anxiety, and depression, alongside frequent healthcare visits and significant resource use. Chronic cough is a primary symptom in numerous conditions, such as refractory chronic cough, idiopathic pulmonary fibrosis (IPF), COPD, asthma, gastro-oesophageal reflux disease (GERD), and cystic fibrosis.

Delivering practical insights for clinical trials and healthcare

C-mo’s primary market focus is the clinical trials sector, where pharmaceutical companies, biotechnology firms, and research organizations are progressively looking for reliable and objective cough metrics. Concurrently, the regulatory approval also facilitates potential future use in clinical and hospital environments.

“This key regulatory achievement strengthens trust in our technology’s quality, safety, and efficacy,” stated Diogo Tecelão, Chief Executive Officer of C-mo Medical Solutions. “We are confident that C-mo can establish a new benchmark for the objective evaluation of cough by facilitating accurate monitoring of its various aspects. With the CE Mark secured, we are ideally equipped to assist pharmaceutical companies, researchers, and healthcare providers in both clinical trials and medical practice.”

“In recent years, accurate and dependable cough analysis has become a significant biomarker in respiratory research,” noted Prof. Surinder Birring, Consultant Respiratory Physician at King’s College Hospital, London, UK. “Nevertheless, only a handful of solutions currently exist that can provide precise cough monitoring appropriate for routine clinical application. The validation outcomes from the C-mo System indicate that cough can be evaluated objectively along several crucial dimensions, such as frequency and intensity, while sustaining high performance across varied patient profiles. This is especially important for clinical trials, where solid and consistent endpoints are critical. The CE Mark approval is a vital move toward broadening the clinical availability of C-mo.”

The CE Mark is anticipated to bolster the Company’s commercial progress as it increases collaboration with pharmaceutical partners, CROs, eClinical partners, researchers, and healthcare professionals. C-mo has created its solution as a new reference point for objective cough evaluation, introducing digital accuracy to a field of care historically dependent on subjective reports or restricted objective instruments.

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About C-mo Medical Solutions

C-mo Medical Solutions is an innovative medtech company dedicated to creating novel solutions that enhance respiratory care. Its goal is to tackle a major gap in the tracking and management of cough, a significant clinical symptom and biomarker in numerous respiratory and other medical disorders.

The Company’s C-mo System is a state-of-the-art cough monitoring platform created for contemporary clinical trials and application in healthcare. By merging a wearable biosensor, AI-based algorithms, and software, the platform provides automated, scalable, and privacy-protecting cough evaluations. The C-mo System is the first technology to offer objective measurement of both cough frequency and intensity without recording private dialogues.

C-mo Medical Solutions holds ISO 13485 certification, conforms to EU MDR 2017/745, and has a Class IIa CE-marked product. The Company also complies with GDPR, HIPAA, and modern cybersecurity standards.

C-mo Medical Solutions is supported by prominent investors such as 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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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.