AI Cough Monitor Earns CE Mark, Targeting Chronic Respiratory Disease

By Nancy Torres

LISBON, Portugal – April 15, 2026 – A novel artificial intelligence-powered wearable designed to objectively monitor coughs has received a pivotal European regulatory approval, signaling a potential new era in the management of chronic respiratory diseases. C-mo Medical Solutions announced today that its C-mo System has earned the CE Mark, clearing its path for broader adoption in clinical trials and future medical practice across the European Union.

The certification designates the C-mo System as a Class IIa medical device under the stringent EU Medical Device Regulation (MDR 2017/745). This approval encompasses the entire platform: a wearable biosensor, sophisticated AI-driven algorithms, and a digital software interface. The system is designed to provide precise, objective measurements of cough frequency, intensity, and bouts, moving beyond the subjective patient diaries that have long been the standard in respiratory care.

This milestone is particularly significant for the estimated 9.6% of adults worldwide who suffer from chronic cough, a persistent symptom linked to conditions like idiopathic pulmonary fibrosis (IPF), COPD, and asthma. For these patients, the condition carries a heavy burden, often leading to sleep disruption, anxiety, and a diminished quality of life.

A New Standard in Objective Monitoring

For decades, clinicians have relied heavily on patient recall to track coughing, a method notoriously prone to inaccuracy. The C-mo System aims to replace this guesswork with hard data. The device is worn by a patient and uses a combination of sensors and AI to analyze cough events without continuously recording audio, a key feature designed to protect user privacy.

"We believe C-mo can set a new standard for objective assessment of cough by enabling precise monitoring of cough across its different dimensions," said Diogo Tecelão, Chief Executive Officer of C-mo Medical Solutions, in a statement. "With CE Mark now in place, we are well positioned to support pharmaceutical companies, researchers and healthcare professionals."

The company's commitment to privacy is a critical differentiator. By engineering the device to activate its microphone only during a detected cough event, it avoids capturing private conversations—a major concern for always-on audio monitoring technologies. This approach, combined with compliance with GDPR and HIPAA data protection standards, is crucial for building trust with both patients and healthcare providers.

C-mo's clinical validation data appears robust. The company reports that in trials involving over 180 subjects, the system demonstrated a median sensitivity of 95.0% and a median specificity of 99.9% in detecting coughs. These figures are competitive within the emerging field of digital cough monitoring, where a recent meta-analysis of similar devices reported a pooled sensitivity of 89% and specificity of 99%.

Navigating a Competitive Digital Health Market

C-mo Medical Solutions enters a dynamic and increasingly competitive market. It is not the only company leveraging AI to quantify coughs. Competitors include Hyfe, with its acoustic AI system used in numerous studies, and Strados Labs, whose RESP Biosensor has already achieved both CE Mark and FDA 510(k) clearance in the United States. Strados Labs' device also provides continuous cough recording and analysis, highlighting the intense innovation in this space.

The challenge for C-mo will be to differentiate its technology and secure market share. Its emphasis on measuring both cough frequency and intensity, alongside its privacy-first architecture, may provide a competitive edge. The backing from prominent investors, including Boehringer Ingelheim Venture Fund, High-Tech Gründerfonds, and Novalis Biotech, lends significant credibility and financial runway. The initial seed funding of €4.8 million ($5.25 million) is fueling the company's push into its first target market: clinical research.

"Precise and reliable cough analysis has emerged as an important biomarker in respiratory research," noted Prof. Surinder Birring, a Consultant Respiratory Physician at King’s College Hospital in London. He highlighted that few solutions can deliver the accuracy needed for clinical use. "The validation results generated with the C-mo System show that cough can be assessed objectively across multiple key dimensions... This is particularly relevant for clinical trials, where robust and reproducible endpoints are essential."

The Long Road from Approval to Widespread Use

Achieving the CE Mark is a monumental step, but it marks the beginning, not the end, of the commercialization journey. While the certification allows the C-mo System to be sold across Europe, it does not guarantee that national health systems will pay for it. The company must now navigate the complex, country-by-country process of securing reimbursement.

This involves engaging with national Health Technology Assessment (HTA) bodies in key markets like Germany and France. These agencies scrutinize new medical devices for clinical added value and cost-effectiveness before recommending them for public funding. This process can be lengthy and requires substantial evidence beyond initial regulatory approval.

C-mo’s initial strategy of focusing on the clinical trials market is a savvy one. Pharmaceutical companies and contract research organizations (CROs) are increasingly seeking objective endpoints to prove the efficacy of new respiratory drugs and are often willing to pay for validated technologies that can provide such data. Success in this sector could generate revenue and build a larger body of evidence to support future reimbursement applications for broader clinical use.

To further bolster its clinical evidence, the company is already running additional studies. An ongoing trial (NCT05989698) aims to enroll 245 patients to further validate the system's performance in detecting and characterizing coughs. This forward-looking research is essential for demonstrating the device's utility across diverse patient populations and solidifying its place as a trusted tool in modern respiratory medicine.