NI AI firm secures US clearance for technology to improve heart rhythm detection from smartwatch ECGs
Dr Alan Kennedy, PulseAI's founder and chief executive
Friday 6 November 2026
A Belfast-based medical technology company has secured US regulatory clearance for artificial intelligence software designed to help detect potentially dangerous heart rhythm disorders, marking a significant milestone for healthcare innovation developed in collaboration with Ulster University.
PulseAI has received clearance from the US Food and Drug Administration (FDA) for its AI-powered arrhythmia analysis software, which examines electrocardiogram (ECG) recordings to identify potential abnormalities in the heart's electrical activity.
The technology could help healthcare professionals make better use of heart rhythm recordings collected through smartwatches and other monitoring devices, while reducing the time spent reviewing results that cannot be clearly interpreted.
Reducing uncertainty in smartwatch heart monitoring
As smartwatches become increasingly common, more people can record their heart rhythms outside hospitals and GP surgeries. However, the growing volume of recordings presents a challenge for healthcare services responsible for interpreting them.
According to market research company IDC, 164 million smartwatches were sold worldwide in 2025, highlighting the scale of consumer technology now capable of supporting health monitoring.
One particular difficulty is inconclusive ECG readings, which can require further clinical assessment, repeat recordings or follow-up appointments.
In a prospective study involving 296 participants, published in the medical journal Heart Rhythm, PulseAI's algorithm reportedly reduced inconclusive interpretations of Apple Watch ECG recordings by 92% compared with the watch's own analysis algorithm.
The study also reported improved sensitivity in detecting atrial fibrillation (AFib), a common heart rhythm disorder that can increase the risk of stroke.
Why detecting atrial fibrillation matters
Atrial fibrillation occurs when the heart beats irregularly and can sometimes go unnoticed because people experience no obvious symptoms.
The condition affects tens of millions of people worldwide and, when untreated, is associated with an approximately fivefold increased risk of ischaemic stroke, although individual risk varies.
Identifying the condition allows healthcare professionals to assess a patient's stroke risk and consider treatment where appropriate.
PulseAI's technology is designed to analyse ECG recordings automatically, helping clinicians identify possible abnormalities and assess results more efficiently. However, the software supports clinical interpretation rather than replacing professional medical judgement.
The company's findings suggest potential benefits for healthcare services, although the reported reduction in inconclusive readings comes from a study of 296 participants and does not, by itself, establish equivalent improvements across all devices or clinical settings.
FDA clearance opens opportunities in US healthcare
The FDA's 510(k) clearance represents an important regulatory step for PulseAI, allowing the cleared technology to be marketed in the United States for its authorised intended use.
It does not mean the software has already been incorporated into every compatible smartwatch or monitoring platform.
PulseAI intends to integrate its technology with compatible ECG devices and software platforms. Recordings are submitted for automated cloud-based analysis, with structured results returned to connected applications for clinical review.
Dr Alan Kennedy, PulseAI's founder and chief executive, said the company wants to help healthcare providers manage the increasing availability of heart rhythm recordings.
“Wearables have made ECG recording widely accessible. Our ambition is to match expanded access with improved accuracy to help deliver a truly scalable solution to providers,” he said.
“Our AI-powered arrhythmia model is an important step toward that goal. With FDA clearance, our focus now is bringing this capability into the devices and platforms in use by millions every day.”
Ulster University research behind the technology
Founded in 2020, PulseAI has developed its technology through a longstanding collaboration with Ulster University, demonstrating how academic research in Northern Ireland can contribute to international healthcare innovation.
Dr Kennedy is an Ulster University alumnus, while the company's chief scientist, Professor Dewar Finlay, is Professor of Electronic Systems and Head of the School of Engineering at the university.
Their collaboration has supported the development of deep learning technology designed to analyse ECG recordings from different sources, including smartwatches, wearable monitoring patches, hospital monitors and defibrillators.
The company says its algorithms have been trained on millions of ECG recordings to support accurate analysis across different monitoring technologies.
Innovation Ulster Limited, the university's innovation, commercialisation and venture development company, has also supported PulseAI's growth.
It led the company's recent seed funding round alongside the Mortara Group, providing investment to help accelerate development of the technology.
Northern Ireland collaboration supports further development
PulseAI and Ulster University continue to work together through regional research initiatives, including the £2.5 million Digital Health Technologies Accelerator and the Centre for Digital Healthcare Technology.
These collaborations focus on advancing digital healthcare and the application of artificial intelligence to cardiac diagnostics.
Ulster University Vice-Chancellor Professor Paul Bartholomew described the FDA clearance as an important achievement for both the company and Northern Ireland's research sector.
“PulseAI is an outstanding example of how pioneering research and expertise, through collaboration with Ulster University, can be transformed into innovative technology with the potential to improve people's lives. Its journey from University spin-in to securing FDA clearance is a significant achievement for the company, the University and Northern Ireland which will benefit patients worldwide.
“This milestone highlights the impact universities can have in driving innovation, investment and high-value jobs while showcasing Northern Ireland's research excellence on the global stage. As an investor through Innovation Ulster Ltd, we warmly congratulate the team and look forward to supporting PulseAI's continued growth and its contribution to advancing cardiac care worldwide.”
For PulseAI, the next challenge is turning regulatory clearance into wider practical use by integrating its software into compatible devices and healthcare platforms. The achievement also demonstrates the potential for research developed in Northern Ireland to influence how heart conditions are detected and monitored internationally.
