Cambridge, UK-based company TidalSense’s N-Tidal Diagnose system identifies chronic obstructive pulmonary disease (COPD) without the need for traditional spirometry. Instead, it combines a state-of-the-art N-Tidal medical device with AI-powered diagnostic software to deliver a COPD diagnosis at the point of care in under five minutes.
It provides a unique COPD diagnostic solution that leverages a revolutionary new patented sensor technology to perform real-time geometric analysis of CO2 breath waveforms. Proprietary algorithms remove noise and isolate clinically relevant patterns in CO2 breath waveforms, properly emphasizing disease-specific patterns.
N-Tidal Diagnose provides highly sensitive quantification of lung function, all from just 75 seconds of relaxed breathing. Users breathe into the cordless N-Tidal medical device, equipped with an industry-leading sensor that captures high-resolution respiratory CO2 data. The sensor detects subtle changes in CO2, including physiologic signals that are too small to detect.
It detects COPD across all severity levels and effectively distinguishes it from other respiratory conditions. The system delivers high-accuracy diagnostic output: 90% sensitivity and 88% specificity, with Positive and Negative Predictive Values of 93%.
N-Tidal Diagnose removes the need for manual interpretation and automates diagnostic reporting. It’s CE-marked under EU Medical Device Regulations (EU MDR) as a class 2a diagnostic device for COPD. Notably, it doesn’t provide FEV1 values but delivers diagnostic output as the likelihood of COPD. It also indicates if severe disease is present.
The platform makes COPD testing faster and more accessible, especially for areas without specialist spirometry resources. It also takes about 10 minutes to train healthcare professionals on how to use the medical device. Models of the handheld device have over 100,000 breath recordings equivalent to >2.5 million patient breaths.
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Images courtesy of TidalSense
