PulseAI wins FDA clearance for wearable arrhythmia analysis model
PulseAI has received U.S. Food and Drug Administration 510(k) clearance for an AI-powered arrhythmia analysis model designed for wearable ECG devices. The Belfast medical technology company said the clearance supports its plans to bring the system to devices and software platforms used by millions of people.
- The FDA granted PulseAI 510(k) clearance for its wearable arrhythmia analysis model.
- A study of 296 participants reported a 92% reduction in inconclusive interpretations versus Apple's native algorithm.
- The model analyses compatible wearable ECG recordings in the cloud.
- PulseAI says its next focus is integration with devices and software platforms.
Model targets inconclusive wearable ECG results
PulseAI develops artificial intelligence for cardiac diagnostics. Its model is designed to analyse recordings from 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.
The company framed the technology as a response to the growing use of wearables, including smartwatches, for heart rhythm monitoring. The announcement cited IDC data showing that 164 million smartwatches were sold worldwide in 2025.
According to PulseAI, healthcare providers face a growing workload when interpreting patient-generated ECG recordings. Inconclusive results can require manual review, repeat recordings and patient follow-up. Reducing those unresolved results could help clinical services assess more recordings with existing resources, the company said.
Study reports improved AFib detection
A prospective study of 296 participants, published in Heart Rhythm, reported that PulseAI's algorithm improved atrial fibrillation detection sensitivity and reduced inconclusive interpretations by 92% compared with the Apple Watch's native algorithm.
Atrial fibrillation, or AFib, is the most common sustained heart rhythm disorder, according to the announcement. 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.
The release also described the published study as reporting up to a 10x performance improvement when the PulseAI model is used with leading wearables. The announcement did not provide further detail on how that figure was measured.
PulseAI plans integration with existing platforms
“With FDA clearance, our focus now is bringing this capability into the devices and platforms in use by millions every day,” Dr Alan Kennedy, PulseAI's CEO and founder, said in the announcement. He said the company's ambition was to pair wider access to ECG recording with improved accuracy.
PulseAI's technology is intended for integration with compatible ECG devices and software platforms rather than use as a standalone wearable. The FDA clearance therefore gives the company regulatory clearance for the model while its next stated focus is incorporating the capability into devices and platforms.
Innovation Ulster Limited, the investment arm of Ulster University, led PulseAI's recent investment round alongside the Mortara Group. PulseAI was founded in 2020 and is based in Belfast, Northern Ireland. The company says its deep learning algorithms were trained on millions of ECGs and are designed for smartwatches, patches, hospital monitors and defibrillators.
