Cambridge, 31 March 2025 - A breakthrough in respiratory diagnostics is set to transform the way serious lung conditions, such as Chronic Obstructive Pulmonary Disease (COPD), are detected and managed in the UK.
N-Tidal™ Diagnose is the first new non-spirometry-based AI COPD diagnostic test to receive clearance under EU Medical Device Regulations. Set to launch in the NHS in the UK from April 2025, this groundbreaking technology offers a game-changing alternative to traditional spirometry - a diagnostic technique dating back to 1846.
Unlike spirometry, which requires forceful breathing and specially trained medical professionals to operate, N-Tidal™ Diagnose provides a simpler, more comfortable solution that reduces strain on healthcare providers and helps tackle long diagnostic waiting times.
With up to 2 million people in the UK undiagnosed, this marks a major breakthrough in respiratory healthcare, promising faster, easier, and more accessible COPD diagnosis and treatment for patients.1
N-Tidal™ Diagnose has been granted regulatory clearance and is CE-marked under EU Medical Device Regulations for the diagnosis of COPD and is now being rolled out across GP practices across the country. Developed by respiratory diagnostic technology company TidalSense, the device uses AI to automatically interpret the CO2 waveform output from a patient's normal breathing pattern and can give an accurate diagnosis in as little as five minutes - making it a fast, cost-effective and patient-friendly alternative to traditional spirometry testing.
COPD affects around three million people in the UK.1 It is the country's third biggest killer, costing the NHS £1.9 billion annually2 and contributing to more than 30,000 deaths each year.3 Many patients face lengthy delays and misdiagnoses, which can lead to more severe illness and hospitalisation.
Data validated for TidalSense by Health Tech Enterprise indicates that around 45,000 patients a year are either under or over treated while waiting for current spirometry testing, with 1,455 patients experiencing a deterioration in their condition as a result of under-treatment.4,5 Meanwhile, data from Asthma and Lung UK shows that only 50% Integrated Care Boards have the capacity to meet demand for spirometry for COPD.6 Delays in diagnosis can allow the condition to worsen, so access to early, accurate testing is essential.
N-Tidal™ Diagnose is set to transform this by enabling a wider range of healthcare professionals, including healthcare assistants in community settings, to conduct COPD tests quickly and accurately, thus helping to reduce waiting times and encourage faster diagnosis and treatment.
The Health Tech Enterprise data also suggests that incorrect prescriptions for mis-diagnosed COPD for patients waiting for spirometry cost the NHS over £15.9m annually.7,8 N-Tidal™ Diagnose can help ease that burden by providing accurate diagnoses which can easily be accessed in the community, reducing waiting times for testing.
Dr Ameera Patel, CEO of TidalSense, said: "For decades, respiratory diagnostics have lagged behind other areas of medicine, despite lung disease being one of the UK's greatest healthcare challenges. The N-Tidal Diagnose device represents the first real breakthrough in COPD diagnosis in several decades, addressing both the needs of the patient and of the health system - and it's designed to be deployed at scale across the NHS. Our goal is to make respiratory diagnosis fast, accurate, and accessible to everyone who needs it, at the instant that they present.
"The NHS is under immense pressure and the Government has laid out ambitious plans to change the way services are delivered. Its targets against reducing waiting times and using staff time more efficiently will be easier to meet with the introduction of new tools like N-Tidal Diagnose. This simple device can help significantly reduce waiting lists, improve patient experience, deliver accurate diagnoses and ultimately provide a better standard of care for the millions of people in the UK who have COPD."
N-Tidal™ Diagnose will be available for use across the NHS from 14th April. Dr Simon Rudland, a GP in Suffolk, said: "COPD is one of the most underdiagnosed and misdiagnosed conditions we see in the NHS, and because spirometry testing can only be carried out by specially trained practitioners, it can lead to sizeable wait lists for diagnosis. Having the ability to assess a patient's lung health quickly and accurately with a device that gives near-instant results will be game-changing for respiratory care across both primary and secondary healthcare settings."
Colin Best, 76 from Suffolk, said: "I was diagnosed with COPD six years ago. I'd been to see my doctor because I couldn't breathe properly with the slightest exertion - even walking was a challenge. After that I was diagnosed with COPD."
"I had to have lots of different tests to diagnose my COPD, all of which were difficult to do and left me gasping for breath. My journey to diagnosis would have been much easier if I could have been tested at my local practice and had a result the same day. I hope that this device helps more people get a rapid diagnosis in the future so they can start treatment and get on with living their lives."
With regulatory clearance now granted, TidalSense is working closely with Integrated Care Boards (ICBs) across the UK to roll out the N-Tidal™ Diagnose device nationally, helping to reduce the burden on GPs, speed up early detection, and ultimately improve patient outcomes.