PulseAI Gains FDA Clearance for Arrhythmia AI
The Belfast-developed software analyzes heart rhythm readings captured by smartwatches and other wearable devices.
Updated on Nov. 6, 2026 in Heart Disease
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PulseAI has received US Food and Drug Administration clearance for its AI-powered software that analyzes ECG heart readings generated by smartwatches and wearable devices. The clearance permits commercial sale of the software in US markets.
Why it matters
The clearance allows doctors to interpret heart rhythm data captured by consumer wearables, a fast-growing source of cardiac readings. With some 164 million smartwatches sold worldwide in 2025, the potential reach of such tools is substantial.
The FDA clearance is a regulatory milestone rather than a clinical outcome study, and the source does not report accuracy or patient-outcome results for the arrhythmia model. Some 164 million smartwatches sold worldwide in 2025 indicates the scale of devices that could feed the software, though the source does not state how many of them produce usable ECG data.
The players
PulseAI
A medical technology company founded in 2020 that develops AI software for analyzing heart rhythm readings from wearable devices.
Dr Alan Kennedy
The founder of PulseAI and an Ulster University alumnus who leads the company's development of AI-powered cardiac analysis.
US Food and Drug Administration
The US federal agency that regulates medical devices and software, and whose clearance permits the commercial sale of PulseAI's product in US markets.
The details
PulseAI's software uses an AI-powered arrhythmia model to analyze heart rhythm recordings, helping doctors interpret ECG readings taken from wearable devices. The company's stated focus is bringing this capability into devices and platforms used by millions of people daily.
Timeline
2020: PulseAI was founded by Dr Alan Kennedy.
2025: Some 164 million smartwatches were sold worldwide.
November 6, 2026: FDA clearance for the PulseAI software was reported.
Big Picture
The clearance extends FDA-regulated use of wearable ECG data beyond the built-in heart-rhythm features of consumer smartwatches to third-party software that helps clinicians interpret those readings. It positions AI arrhythmia analysis as a layer that can sit on top of the growing installed base of wearables.
Readers who wear smartwatches may eventually have heart rhythm recordings interpreted by clinicians using tools like this one. The source does not say when or where the software will be available to patients or what it will cost.
The takeaway
Wearable heart data is becoming a clinical input as well as a consumer feature, so people who track their heart rhythm may increasingly have those readings reviewed by doctors. Watch for clinical evidence and availability details as the software reaches providers.
Further reading
For more on the conditions this technology targets, see Heart Disease coverage on Wisevoter.
Source note: This article includes information reported by The Irish News.
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