N-Tidal Diagnose

TidalSense is a respiratory diagnostic technology company based in Cambridge.

N-Tidal Diagnose, a product from TidalSense, is a point of care diagnostic medical device (CE-marked class 2a regulated under EU MDR) that can be used to diagnose patients with Chronic Obstructive Pulmonary Disease (COPD).

N-Tidal Diagnose performs real-time analysis of breath waveforms captured on the N-Tidal Handset, which contains an innovative fast-response carbon dioxide sensor embedded within a connected, handheld device. Using the handset requires only 75 seconds of normal relaxed breathing. N-Tidal Diagnose then applies its AI diagnostic algorithms to the waveform to output the likelihood that the patient being tested has COPD. A diagnostic output is displayed for the clinician within five minutes of using the handset. A broad range of healthcare professionals, including healthcare assistants, can be trained to use this rapid and highly accurate point of care diagnostic test without the need for Association for Respiratory Technology & Physiology (ARTP) accreditation.

Diagnosing COPD in the community

Chronic Obstructive Pulmonary Disease (COPD) is a lung condition characterised by chronic respiratory symptoms that is associated with persistent and progressively worsening airflow obstruction. Approximately 1.4 million people aged 40 years or over in England have a diagnosis of COPD with an estimated 2 million remain undiagnosed (1).

The prevalence and severity of COPD increases with age and the earlier a diagnosis the better the long-term health outcomes. Diagnosis of COPD is the crucial first step in effective management of the disease – treatment slows the decline in lung function and reduces the chances of needing to attend hospital with an exacerbation, reducing winter pressures.

Spirometry services, the current standard diagnostic test for the condition, have been under pressure for some time. Community spirometry was halted during the COVID-19 pandemic and has not recovered in many places across the UK, creating a substantial bottleneck and waiting list for this diagnostic test.

The need for specialist ARTP qualified clinicians to deliver the test limits the ability for the test to be delivered in a primary care setting, increasing the burden on specialist or secondary care centres with patients who could otherwise be diagnosed in a community setting.

N-Tidal Diagnose aims to significantly reduce the need for spirometry services, reducing diagnostic delays for patients, reducing overall service cost and lowering secondary care referrals in the process.

N-Tidal Diagnose recently received regulatory approval (March 2025) and therefore projects to evaluate its real-world impact are being finalised. It is anticipated to be most effective in primary care, bringing diagnostic services for COPD to the community. However, from existing evidence, including Budget Impact Modelling, N-Tidal Diagnose is expected to be able to:

• Reduce the delay between the first time a patient presents with symptoms and when they receive a COPD diagnosis
• Reduce the waiting lists of those currently referred for spirometry for COPD
• Be easier for primary care services to use than spirometry, including a shorter training period for staff and a shorter appointment time (under 10 minutes) compared with spirometry. N-Tidal Diagnose enables allied healthcare professionals such as healthcare assistants to be able to effectively administer COPD diagnostic testing.
• Provide cost saving for health services.

References:

(1) https://cks.nice.org.uk/topics/chronic-obstructive-pulmonary-disease/background-information/prevalence-incidence/