The Pulse

FDA Cleared PulseAI’s Arrhythmia Analysis Model for Wearables Under 510(k), Company Says

The FDA granted 510(k) clearance for PulseAI’s AI-powered arrhythmia analysis model for wearables, the company says. The company cited a 296-participant study reporting improved AFib detection sensitivity and a 92% reduction in inconclusive

AI.info Team · Written with AI · fact-checked · 2026-11-06

PulseAI announces FDA clearance

PulseAI announced on Nov. 5, 2026, that the U.S. Food and Drug Administration had granted 510(k) clearance for its AI-powered arrhythmia analysis model for wearables. The Belfast-based medical technology company develops artificial intelligence for cardiac diagnostics. Its technology is designed to integrate with compatible ECG devices and software platforms.

The company’s announcement comes as smartwatches and other wearables make heart rhythm recording more common outside hospitals and clinics. The release cited IDC figures showing that 164 million smartwatches were sold worldwide in 2025. Most models provide some form of heart rhythm monitoring, the release said, while healthcare providers face the challenge of interpreting those recordings without a corresponding rise in clinical labor.

Study reports fewer inconclusive readings

PulseAI pointed to a prospective study of 296 participants, published in Heart Rhythm. The company’s AI algorithm improved atrial fibrillation (AFib) detection sensitivity and reported a 92% reduction in inconclusive interpretations compared with the Apple Watch’s native algorithm, according to the release.

Inconclusive ECG interpretations can require manual review, repeat recordings and patient follow-up. Reducing unresolved results could lower the staff time needed to assess patient-generated ECGs, helping clinical services handle more recordings with existing resources, the release says.

The release describes AFib as the most common sustained heart rhythm disorder, affecting tens of millions of people worldwide. It can occur without symptoms and, when untreated, is associated with around a fivefold higher risk of ischaemic stroke, depending on individual risk factors. Identifying AFib enables clinicians to assess stroke risk and consider appropriate treatment.

Company describes its next steps

PulseAI CEO and Founder Dr Alan Kennedy said the company aims to pair the wider availability of ECG recordings with improved accuracy. The release quoted him as saying: “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.”

PulseAI’s technology is designed for integration with compatible ECG devices and software platforms. Recordings are submitted for automated analysis in the cloud, with structured results returned to the connected application for clinical review.

University investment and company background

Innovation Ulster Limited, the investment arm of Ulster University, led PulseAI’s recent investment round alongside the Mortara Group. Ulster University Vice Chancellor Professor Paul Bartholomew said: “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.”

Founded in 2020, PulseAI is based in Belfast, Northern Ireland. The company says its deep learning algorithms were trained on millions of ECGs and deliver clinically validated performance across smartwatches, patches, hospital monitors and defibrillators.