AI Tool Reads Smartwatch Heart Data for Doctors
FDA-cleared software from PulseAI helps clinicians interpret ECG readings from wearable devices used by millions.
Updated on Nov. 6, 2026 in Heart Disease
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PulseAI, a medical technology company founded in 2020 by Dr Alan Kennedy, received US Food and Drug Administration clearance for its AI-powered software that analyzes heart rhythm readings from smartwatches and wearable devices. The clearance permits commercial sale of the software in US markets.
Why it matters
Heart rhythm irregularities such as arrhythmias can be detected through ECG readings, and wearable devices are now a common way people collect that data. A tool that helps doctors interpret those wearable readings could make it easier to turn consumer-device recordings into clinically useful information, and the timing reflects how widely these devices have spread.
The FDA clearance grants permission for commercial sale of the software in US markets. The source does not describe the study design, sample size, or measured accuracy results behind the clearance.
The players
PulseAI
A medical technology company founded in 2020 that develops AI-powered software for analyzing ECG heart readings from wearable devices.
Dr Alan Kennedy
Founder of PulseAI and an Ulster University alumnus.
US Food and Drug Administration
The US federal agency responsible for regulating medical devices, including software that analyzes heart data.
The details
The software uses an AI-powered arrhythmia model to analyze heart rhythm recordings captured by smartwatches and other wearables. It is designed to help doctors interpret the ECG readings those devices generate. PulseAI's stated focus is bringing this arrhythmia capability into devices and platforms that millions of people use every day.
Timeline
2025: some 164 million smartwatches were sold worldwide.
- 2026-11-06
FDA clearance for PulseAI's software was reported.
Health Landscape
Wearable devices are increasingly collecting heart rhythm data outside clinical settings, creating a gap between consumer readings and physician interpretation. Tools that help clinicians read these recordings address a growing volume of data that conventional care pathways were not built to handle.
If you use a smartwatch or wearable that records heart rhythm, this development points toward more tools that help your doctor interpret those readings. Any concern about an irregular heartbeat is worth raising with your physician rather than relying on a device reading alone.
The takeaway
Consumer wearables are generating more heart rhythm data than ever, and tools that help clinicians interpret it are arriving. Bring any device-flagged irregular rhythm to your doctor for proper evaluation.
Further reading
For more on the conditions these heart-rhythm tools are designed to detect, see our Heart Disease coverage.
Source note: This article includes information reported by The Irish News.
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Do you trust AI tools to accurately read your smartwatch heart data?
