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Top FDA-Cleared Wearable Heart Rate Monitors for Atrial Fibrillation Detection

A curated selection of wearable devices and smartwatches that have received FDA clearance for detecting atrial fibrillation (AFib). These devices utilize advanced optical sensors or single-lead ECG technology to provide users with clinical-grade insights into their heart rhythm, enabling early detection and informed healthcare decisions.

ID: 35735
Items: 20
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Apple Watch Series 9

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Features an FDA-cleared ECG app that allows users to take a heart rhythm reading directly from the wrist. It also includes irregular rhythm notifications and heart rate alerts, providing comprehensive cardiovascular monitoring for everyday users seeking clinical-grade insights.

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Fitbit Sense 2

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Offers an FDA-cleared ECG app capable of detecting signs of atrial fibrillation. This wellness-focused wearable combines health metrics with a sleek design, making it an excellent choice for users who want seamless daily tracking alongside occasional clinical heart checks.

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Withings ScanWatch 2

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A hybrid smartwatch featuring a built-in medical-grade ECG sensor cleared by the FDA for AFib detection. It provides continuous heart rate monitoring and tracks sleep apnea risk, offering a sophisticated blend of traditional watch aesthetics and advanced health diagnostics.

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Samsung Galaxy Watch 6

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Includes an FDA-cleared ECG feature that enables users to measure their heart rhythm for signs of AFib or sinus rhythm. The device integrates these insights with other health metrics, providing a robust platform for users already invested in the Samsung ecosystem.

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Biofourmis BioVU II

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A wireless wearable patch designed for continuous cardiac monitoring, cleared by the FDA for detecting atrial fibrillation. It is primarily used in clinical settings but offers high-fidelity data capture for patients requiring sustained monitoring over extended periods.

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iHealth Track

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A compact, non-wrist wearable patch that provides FDA-cleared ECG monitoring for atrial fibrillation. Its small form factor allows for discreet, continuous use, making it suitable for users who prefer a chest or clothing-mounted sensor over a traditional smartwatch.

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Omron HeartGuide

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The world's first FDA-cleared wearable blood pressure monitor that also includes heart rate irregularity detection. It measures BP accurately via an inflation cuff and provides ECG data, offering a unique combination of hemodynamic and rhythm monitoring in one device.

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AliveCor KardiaBand

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A small, clip-on accessory that turns any smartphone into a clinical-grade, single-lead ECG device. It is FDA-cleared for detecting AFib, normal sinus rhythm, and bradycardia, providing portable, on-demand cardiac monitoring for users who already own a compatible phone.

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AliveCor KardiaMobile 6L

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A FDA-cleared mobile cardiac monitor that generates a six-lead ECG using a smartphone and proprietary hardware. It offers a more comprehensive view of heart activity than single-lead options, allowing for detailed analysis of atrial fibrillation and other cardiac abnormalities.

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Biovotion HeartMate

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A chest strap heart rate monitor that provides FDA-cleared ECG data for detecting atrial fibrillation. Designed for athletes and fitness enthusiasts, it offers real-time heart rhythm feedback alongside standard performance metrics like intensity zones and recovery time.

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Polar Vantage V3

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A high-end multisport watch that features an FDA-cleared ECG app for detecting atrial fibrillation. It combines professional-grade training tools with cardiovascular health monitoring, ensuring that serious athletes can track both performance and heart rhythm safety.

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Garmin Venu 3

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Features an FDA-cleared ECG app that allows users to check their heart rhythm for signs of atrial fibrillation. It integrates these health insights with Garmin's robust fitness tracking capabilities, providing a holistic view of physical health and cardiac wellness.

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Empatica Embrace2

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An FDA-cleared seizure and AFib monitoring wearable designed for individuals with epilepsy or cardiac conditions. It detects generalized tonic-clonic seizures and irregular heart rhythms, offering critical alerts and data logging for caregivers and medical professionals.

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Quartet HeartWatch

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A smartwatch specifically designed for heart health, featuring a medical-grade ECG sensor cleared by the FDA. It provides 24/7 continuous monitoring for atrial fibrillation and heart rate variability, focusing exclusively on cardiovascular metrics rather than general fitness.

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Livax LivaNex

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A disposable, single-use skin patch that monitors heart rhythm and detects atrial fibrillation. It is FDA-cleared for continuous use over several days, providing a lightweight alternative to bulky wearables for patients who need short-term, high-fidelity cardiac monitoring.

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CardioMoov

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A wrist-worn device that combines heart rate monitoring with ECG capabilities for detecting atrial fibrillation. It is designed for ease of use, offering clear visual indicators of heart rhythm status, making it accessible for older adults or those less tech-savvy.

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iHealth Wave

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A wearable blood pressure monitor that also includes heart rate irregularity detection. While primarily focused on BP, its integrated sensors help identify abnormal heart rhythms, offering a dual-function device for users managing both hypertension and potential arrhythmias.

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Zoll Q-CPR Monitor

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A wearable patch used primarily in emergency and hospital settings that monitors heart rhythm and detects AFib. It is FDA-cleared for continuous telemetry, providing real-time data transmission to healthcare providers for immediate clinical intervention and assessment.

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Schiller AT-10

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A compact, portable ECG device that includes software for detecting atrial fibrillation. Though often used in clinical exams, its portable nature allows some healthcare providers to use it for extended monitoring setups, bridging the gap between hospital and home care.

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Philips HeartStart OnCor

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A portable heart monitor that can be worn by patients to continuously record heart rhythms. It is FDA-cleared for detecting AFib and other arrhythmias, transmitting data wirelessly to healthcare providers for review and diagnosis without requiring a clinic visit.