'An outstanding example': Belfast AI firm secures US approval for life-saving heart-monitoring technology
PulseAI, founded by an Ulster University graduate, wins FDA clearance for software designed to improve the detection of heart rhythm disorders and reduce inconclusive smartwatch ECG results
Belfast-based medical technology company PulseAI has secured US regulatory clearance for its artificial intelligence software, which is designed to help detect heart rhythm disorders and improve the analysis of smartwatch ECG recordings.
The company has received 510(k) clearance from the US Food and Drug Administration (FDA) for its AI-powered arrhythmia analysis model, marking a significant milestone in its ambitions to bring its technology to healthcare providers and device manufacturers worldwide.
Founded in 2020 by Ulster University alumnus Dr Alan Kennedy, PulseAI develops artificial intelligence for cardiac diagnostics, using deep learning technology to analyse electrocardiogram (ECG) recordings and identify potential abnormalities.
The technology comes as the use of wearable devices, including smartwatches, continues to grow, with an estimated 164 million smartwatches sold worldwide in 2025, according to IDC.
While many devices now offer some form of heart rhythm monitoring, the increasing volume of recordings presents a challenge for healthcare providers, particularly when it comes to interpreting inconclusive results.
In a prospective study involving 296 participants, published in the journal Heart Rhythm, PulseAI's algorithm improved the sensitivity of atrial fibrillation (AFib) detection and reported a 92% reduction in inconclusive interpretations compared with the Apple Watch's native algorithm.
AFib is the most common sustained heart rhythm disorder and can increase the risk of stroke if left untreated.
PulseAI said reducing inconclusive results could help cut the time clinicians spend manually reviewing recordings, requesting repeat tests and following up with patients.
Dr Kennedy, CEO and founder of PulseAI, said: “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.
“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.”
The software is designed to integrate with compatible ECG devices and platforms, with recordings submitted for automated cloud-based analysis and structured results returned to applications for clinical review.
PulseAI has developed its technology through a longstanding relationship with Ulster University, where its proprietary deep learning algorithms for ECG analysis were developed in collaboration with the University's research expertise.
Professor Dewar Finlay, PulseAI's chief scientist and professor of electronic systems at Ulster University, has played a key role in the partnership, which has helped take the technology from academic research towards commercialisation.
Innovation Ulster Limited, the University's innovation, commercialisation and venture development company, has also supported the business's growth and led its recent seed funding round alongside the Mortara Group.
The company continues to collaborate with Ulster University through regional initiatives including the £2.5m Digital Health Technologies Accelerator and the Centre for Digital Healthcare Technology.
Ulster University vice-chancellor Professor Paul Bartholomew added: “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.”
The Belfast-based company was founded in 2020 and has developed algorithms trained on millions of ECG recordings, with applications across smartwatches, wearable patches, hospital monitors and defibrillators.