TidalSense has developed, regulated and is bringing to market, a rapid, high accuracy and easy-to-use diagnostic test for COPD, which has potential to replace spirometry in respiratory diagnostic pathways. N-Tidal Diagnose (R) combines a novel, patented, and innovative fast-response CO2 sensor embedded within a connected, handheld and battery-operated handset (N-Tidal Handset), with AI algorithms that can sensitively detect changes in lung physiology consistent with obstructive respiratory diseases such as COPD (N-Tidal Diagnose software). N-Tidal Diagnose (R) is now CE-marked as a certified Class 2a medical device under EU Medical Device Regulations (MDR) for use in COPD diagnosis. It is the first non-spirometry-based diagnostic technology to be certified for COPD diagnosis under EU MDR.