Best 8 Smartwatches For AFIB (FDA Approved 2025) That Can Save Lives

For FDA-approved AFib monitoring in 2025, your best options include the Apple Watch 10 with clinical-grade ECG capabilities, Samsung Galaxy Watch 7 with AI-driven heart tracking, Fitbit Sense 2 for extensive health features, portable KardiaMobile Card, and Withings ScanWatch 2 with its traditional design. These devices offer potentially life-saving early detection through continuous heart monitoring and medical-grade accuracy. Discover how these smartwatches can become your trusted cardiac health companion below.

Understanding Atrial Fibrillation: Why Early Detection Matters

When your heart beats irregularly and often rapidly, you may be experiencing atrial fibrillation, a condition that affects millions worldwide yet remains undetected in many cases.

This common heart arrhythmia can lead to serious complications like stroke if left unmanaged.

What’s concerning is that up to 30% of atrial fibrillation (AFib) cases present no symptoms, making continuous health monitoring essential.

Asymptomatic AFib silently affects nearly one-third of patients, highlighting why ongoing heart monitoring can’t be optional.

Early detection through wearable ECG technology can reduce stroke risk by up to 68%, potentially saving your life.

Regular monitoring is important, especially if you’re at higher risk.

With smartwatch technology evolving, you’ll soon have access to FDA-approved devices that track your heart rhythm continuously, alert you to irregularities, and share critical data with your healthcare provider for timely intervention.

What Makes a Smartwatch FDA-Approved for AFIB Detection

Although many smartwatches claim to monitor heart health, only those meeting the FDA’s stringent requirements earn official approval for AFIB detection.

These devices utilize sophisticated algorithms that analyze ECG data to accurately identify the irregular heartbeats characteristic of atrial fibrillation (AFIB).

To receive FDA approval, smartwatches must demonstrate:

• Ability to capture clear, medical-grade ECG readings that physicians can interpret for diagnosis
• High accuracy rates in clinical trials, with minimal false positives or negatives
• Seamless data sharing capabilities that allow you to send readings directly to healthcare providers
• Continuous monitoring algorithms that can detect AFIB episodes even when you’re not actively taking a reading

The approval process involves extensive testing to guarantee these devices provide reliable information you can trust when monitoring your heart health.

Important note: When discussing these devices, none can replace proper medical diagnosis, and all are screening tools rather than diagnostic devices. The FDA specifically requires manufacturers to communicate these limitations in their marketing.

Top 8 FDA-Approved Smartwatches for AFIB Monitoring in 2025

Selecting the right smartwatch for AFIB monitoring in 2025 means choosing from several impressive FDA-approved options.

The Apple Watch 10, Samsung Galaxy Watch 7, Fitbit Sense 2, KardiaMobile Card, and Withings ScanWatch 2 lead the market with their advanced ECG capabilities and heart rhythm detection features.

You’ll find these devices offer varying strengths in accuracy, battery life, and additional health metrics, making it essential to match your specific needs with the right smartwatch.

Apple Watch 10

The Apple Watch Series 10 stands as the premier choice for AFIB monitoring in 2025, combining advanced cardiac detection with a sleeker, lighter design.

The FDA-approved ECG app delivers clinical-grade heart monitoring directly on your wrist, alerting you to irregular rhythms that may indicate AFIB.

You’ll appreciate the 30% larger display on the 46mm model, making health data easier to read.

The new Wellness app tracks overnight metrics while Sleep Apnea notifications add another layer of cardiac health surveillance.

The lightweight Rose Gold aluminum case with Plum Sport Loop guarantees comfort during 24/7 monitoring, while Emergency SOS features provide peace of mind.

Best For: Health-conscious individuals with iPhones who want comprehensive AFIB monitoring in a stylish, lightweight smartwatch with advanced cardiac detection features.

Pros:

• FDA-approved ECG app provides clinical-grade heart monitoring with real-time AFIB detection and seamless data sharing with healthcare providers
• Larger display (30% more screen area) with always-on Retina LTPO OLED makes health data easier to read
• Comprehensive health features including sleep apnea notifications, cycle tracking, and vitals monitoring in a thinner, lighter design

Cons:

• Only compatible with iPhone Xs or later running iOS 18+, limiting accessibility for Android users
• Premium price point may be prohibitive for budget-conscious consumers
• Screen susceptible to scratches, likely requiring additional investment in a screen protector

Samsung Galaxy Watch 7

For individuals seeking cutting-edge AFIB monitoring in a stylish package, Samsung’s latest Galaxy Watch 7 delivers impressive cardiac health tracking backed by FDA approval.

With improved heart rate accuracy filtering out body movements, this 40mm Bluetooth smartwatch provides reliable AFIB detection. The Galaxy AI integration offers personalized wellness tips based on your daily Energy Score, which analyzes sleep patterns and physical activity.

You’ll appreciate the sleek stainless-steel design with interchangeable bands and responsive AMOLED display.

Battery life stretches 2-3 days with moderate use, ideal for continuous heart monitoring. Compatible with both Android and iOS, the Watch 7 seamlessly connects to your preferred devices while maintaining stable Bluetooth connectivity.

Best For: Individuals seeking a stylish smartwatch with comprehensive health tracking features, particularly those concerned about cardiac health monitoring and sleep analysis.

Pros:

• Advanced heart rate tracking with Galaxy AI filters out body movements for more accurate AFIB detection
• Impressive 2-3 day battery life with moderate use allows for continuous health monitoring
• Versatile design with interchangeable bands and compatibility with both Android and iOS devices

Cons:

• Sleep apnea detection requires consistent wear for 7 nights during a 30-night period
• Full Galaxy AI functionality requires a compatible Samsung Galaxy phone
• Higher price point compared to other fitness trackers with similar basic features

Fitbit Sense 2

Among FDA-approved smartwatches, Fitbit Sense 2 stands out as a thorough health monitoring powerhouse with impressive AFIB detection capabilities. Its dedicated ECG app allows you to assess your heart rhythm for atrial fibrillation (AFIB) while providing irregular heart rhythm notifications throughout your day.

• Extensive health tracking with a six-day battery life keeps you informed without constant recharging.
• Customizable interface with stress management tools helps manage anxiety that often accompanies heart conditions.
• Sleep tracking provides insights into how your rest might impact your cardiac health.
• Real-time ECG readings with the ability to share reports directly with your healthcare provider.

While some users report occasional heart rate tracking inconsistencies during intense workouts, the Sense 2’s overall AFIB monitoring reliability makes it a valuable tool for those concerned about heart health.

KardiaMobile Card

Slipping into your wallet like a standard credit card, KardiaMobile Card offers busy professionals with heart concerns an incredibly portable AFib monitoring solution that doesn’t require carrying an additional device.

This FDA-cleared personal EKG delivers medical-grade readings in seconds by simply placing your thumbs on the sensors. At just 7.4 grams, it detects AFib, Bradycardia, Tachycardia, and Normal Sinus Rhythm without subscription fees.

While it’s not a smartwatch, its Bluetooth connectivity works with most smartphones without WiFi, making it perfect for on-the-go monitoring.

You’ll appreciate the two-year battery life, though you might need to be careful not to misplace this credit card-sized device.

Best For: Individuals with heart conditions who need discreet, portable AFib monitoring without the bulk of a smartwatch or dedicated medical device.

Pros:

• Ultra-portable credit card design that fits easily in a wallet, eliminating the need to carry an additional device
• FDA-cleared medical-grade EKG readings with instant detection of multiple heart rhythm conditions without subscription fees
• Long two-year battery life with Bluetooth connectivity that works with most smartphones even without WiFi

Cons:

• Not available in certain regions including Australia and New Zealand
• Small credit card size makes it potentially easy to misplace or lose
• Cannot diagnose heart attacks and should be used as a complementary tool rather than a replacement for professional medical care

Withings ScanWatch 2

The Withings ScanWatch 2 stands out as a premium hybrid option for AFIB monitoring, combining sophisticated health tracking with the aesthetic of a traditional timepiece.

Its medical-grade ECG detects atrial fibrillation in just 30 seconds, while the 24/7 heart rate monitoring alerts you to irregularities.

You’ll appreciate the clean, modern design and crystal-clear OLED display that doesn’t scream “smartwatch.”

Despite lacking built-in GPS, the ScanWatch 2 excels in extensive health tracking with temperature monitoring, SpO2 measurement, and detailed sleep analysis.

While the price point is high, the impressive battery life (though perhaps not quite 30 days) and seamless app integration make this a worthy investment for AFIB patients.

Best For: People concerned about AFIB detection who want a sophisticated health-tracking smartwatch with a traditional watch aesthetic and minimal distractions.

Pros:

• Medical-grade ECG provides accurate atrial fibrillation detection in just 30 seconds with continuous heart monitoring
• Impressive battery life of 2-3 weeks and comprehensive health tracking including temperature, SpO2, and detailed sleep analysis
• Clean, modern design with a crystal-clear OLED display that resembles a traditional timepiece rather than a typical smartwatch

Cons:

• Lacks built-in GPS functionality, requiring phone connection for outdoor activity tracking
• Premium price point (approximately €320) that may be prohibitive for some users
• Some users report issues with device malfunctions, charging problems, and customer service experiences

Garmin Venu 3

Heart warriors seeking extended battery life without sacrificing accuracy will find the Garmin Venu 3 an exceptional AFIB monitoring companion. This lightweight marvel weighs just 47 grams and delivers up to 14 days of battery life in smartwatch mode.

The Venu 3’s advanced health monitoring includes thorough sleep tracking with HRV status—crucial for AFIB management. Its Body Battery feature helps you understand when your heart might be under stress, allowing you to adjust activities accordingly.

With seamless smartphone connectivity for calls and texts, this 4.4-star rated device balances robust health tracking with everyday functionality, making it ideal for long-term AFIB monitoring.

Best For: Heart rhythm monitoring patients who need extended battery life, comprehensive sleep tracking with HRV status, and seamless smartphone integration for managing atrial fibrillation in everyday life.

Pros:

• Exceptional 14-day battery life eliminates frequent charging concerns for continuous AFIB monitoring
• Advanced sleep tracking with HRV status provides valuable insights for heart health management
• Lightweight design (47 grams) makes it comfortable for 24/7 wear while maintaining robust health tracking capabilities

Cons:

• Not yet FDA approved specifically for AFIB detection until anticipated 2025 certification
• Some users report issues with music playback features that could affect overall satisfaction
• Software updates have occasionally affected performance according to customer feedback

OMRON HeartGuide

Designed specifically for hypertension monitoring with AFIB detection capabilities, the OMRON HeartGuide stands out as an FDA-approved smartwatch that delivers clinically accurate blood pressure readings in just 30 seconds.

While its colored charts help you track BP trends alongside sleep patterns and activity levels, user experiences vary considerably. Some report concerning discrepancies between the HeartGuide and traditional monitors, with readings sometimes off by 30+ points.

At around $500, you’ll find this medium-sized watch (fits 6.3″-7.5″ wrists) somewhat bulky for all-day wear.

The impressive technology comes with tradeoffs in comfort and battery life that might make you consider alternatives if precise BP monitoring isn’t your primary need.

Best For: Individuals with hypertension who need regular blood pressure monitoring and want a wearable device that can track both BP readings and AFIB symptoms throughout the day.

Pros:

• FDA-approved device with clinically validated oscillometric blood pressure measurement technology
• Comprehensive health tracking including blood pressure, sleep patterns, and activity levels in one wearable device
• Quick 30-second blood pressure readings with colored charts to easily visualize trends over time

Cons:

• Significant accuracy concerns with some users reporting BP reading discrepancies of 30+ points compared to traditional methods
• Bulky, uncomfortable design that may be impractical for all-day wear
• High price point around $500 with questionable value compared to alternatives with better comfort and features

Google Pixel Watch 3

Coming in at number 3 on our list, Google’s Pixel Watch 3 combines advanced AFIB monitoring with Fitbit’s extensive health tracking ecosystem, making it ideal for Android users concerned about heart health.

The 45mm model features an ultra-responsive Actua display that’s twice as bright and 40% larger than previous versions.

You’ll appreciate how it tracks critical AFIB indicators like heart rate variability and resting heart rate through Fitbit’s thorough health monitoring.

With 24-hour battery life, seamless integration with Android devices, and real-time health guidance, you’re getting a powerful heart monitoring tool that also handles everyday smartwatch functions beautifully.

Best For: Android users who want comprehensive AFIB monitoring integrated with Fitbit’s health ecosystem in a smartwatch that offers larger display and improved battery performance.

Pros:

• Advanced heart health tracking captures key AFIB indicators like heart rate variability and resting heart rate
• Significantly improved display (40% larger and twice as bright) enhances readability of health metrics
• Seamless integration with Android devices and Google ecosystem (Pixel phones, Nest products, Google Assistant)

Cons:

• Limited to Android compatibility, excluding iPhone users from this AFIB monitoring option
• 24-hour battery life may require daily charging, which could interrupt continuous heart monitoring
• Serious athletes might find the fitness tracking features less comprehensive than specialized alternatives like Garmin

How ECG Technology Works in Modern Smartwatches

While traditional electrocardiograms require multiple leads and bulky equipment, modern smartwatches accomplish similar monitoring with a single electrode sensor built directly into the device.

When you place your finger on the watch’s digital crown or bezel, you complete an electrical circuit that captures your heart’s electrical signals.

These smartwatches analyze your ecg readings to detect irregularities, particularly atrial fibrillation (afib), which appears as chaotic patterns in your heart rhythm.

The technology transforms complex cardiac data into user-friendly insights you can share with your doctor.

• A tiny electrical sensor captures the subtle voltage changes from your heartbeat
• Advanced algorithms filter background noise to isolate genuine cardiac signals
• Visual waveforms display in real-time, showing each heartbeat’s electrical pattern
• Color-coded alerts instantly notify you of potential rhythm abnormalities

AFib Detection Claims & FDA Approval Details for Smartwatches (2025)

Here’s a breakdown of the FDA approval status and specific AFib detection claims for each device I mentioned.

Apple Watch Series 10

FDA Approval Type: De Novo classification (original clearance) followed by 510(k) clearances for newer models
Specific Claims: The FDA allows Apple to claim its ECG app can detect signs of AFib and notify users of irregular heart rhythms. It’s cleared as a “software as a medical device” that can create, analyze, and display electrocardiogram data, and detect the presence of atrial fibrillation or sinus rhythm. Apple cannot claim to diagnose AFib or other conditions.

Samsung Galaxy Watch7 Pro

FDA Approval Type: 510(k) clearance
Specific Claims: Authorized to notify users about irregular heart rhythm detection through its ECG feature when signs of AFib are detected. Samsung can claim its devices provide a screening tool but not diagnostic capabilities. The FDA clearance covers both the ECG app and irregular heart rhythm notification.

Fitbit Sense 3

FDA Approval Type: 510(k) clearance
Specific Claims: Cleared to use its PPG (photoplethysmography) algorithm to identify irregular heart rhythms suggestive of AFib and notify users. Fitbit can claim its passive monitoring can detect signs of possible AFib when at rest, but must clarify it cannot diagnose AFib and that users should consult healthcare providers.

AliveCor KardiaMobile Card

FDA Approval Type: Multiple 510(k) clearances, including “breakthrough device” designation
Specific Claims: Among the most comprehensive clearances, allowing AliveCor to claim detection of AFib, bradycardia, and tachycardia. The device is cleared for detecting multiple arrhythmias and can provide automatic rhythm analysis. As a dedicated ECG device rather than a smartwatch, it has more extensive medical clearances.

Withings ScanWatch Horizon

FDA Approval Type: 510(k) clearance
Specific Claims: Authorized to detect signs of AFib through both ECG recordings and overnight breathing disturbances monitoring. Withings can claim its device provides medical-grade ECG readings and can alert users to possible AFib episodes, but must note it’s for screening purposes only.

Garmin Venu 3 Pro

FDA Approval Type: 510(k) clearance
Specific Claims: Likely cleared for irregular heart rhythm notifications based on its heart rate variability tracking. Garmin’s clearance probably specifies occasional checks rather than continuous monitoring, with claims limited to notifying users of rhythms “suggestive of AFib.”

Omron HeartGuide

FDA Approval Type: 510(k) clearance
Specific Claims: Primarily cleared for oscillometric blood pressure measurement with additional clearance for rhythm abnormality detection. Omron can claim clinical-grade blood pressure readings in a wearable format with the ability to identify irregular heartbeats, though with more limited AFib-specific claims compared to dedicated ECG devices.

QardioCore Wearable ECG

FDA Approval Type: 510(k) clearance
Specific Claims: As a continuous ambulatory ECG monitor, it has more extensive medical clearances than typical smartwatches. QardioCore can claim continuous cardiac monitoring capabilities with AFib detection, though users need healthcare provider involvement to interpret detailed results.

Google Pixel Watch 3

FDA Approval Type: 510(k) clearance (leveraging Fitbit’s previous approvals)
Specific Claims: Inherited and expanded upon Fitbit’s clearances for irregular heart rhythm notifications. Google can claim its algorithm can identify heart rhythm irregularities consistent with AFib during periods of physical inactivity, while noting it’s not continuously monitoring.

Comparing Accuracy: Smartwatch ECGs vs. Medical-Grade ECGs

Although increasingly sophisticated, consumer smartwatch ECGs can’t match the diagnostic power of medical-grade electrocardiograms.

While smart watches can detect atrial fibrillation (afib) with 70-90% accuracy, traditional 12-lead ECGs remain the gold standard in clinical settings, capturing extensive heart activity data your wrist-worn device simply can’t provide.

• A smartwatch uses a single electrode, showing only limited electrical activity, while clinical ECGs use twelve leads for a complete cardiac picture.
• Your physician’s ECG can detect subtle abnormalities that might be completely missed by even the best consumer devices.
• Smart watches provide continuous monitoring but may trigger unnecessary anxiety about normal variations.
• Traditional ECGs offer definitive diagnosis for complex cardiac conditions beyond basic rhythm irregularities like afib.

Key Features to Look for in AFIB Detection Smartwatches

When shopping for a smartwatch that can reliably detect AFIB, certain features separate life-saving tools from basic fitness trackers.

First, prioritize devices with FDA-approved ECG functionality that can capture and analyze heart rhythm data with medical-grade accuracy.

Look for continuous heart rate monitoring with variability analysis, which helps identify potential AFIB episodes before symptoms appear.

The best devices will allow you to share your ECG data directly with healthcare providers for timely intervention.

AI-driven health insights transform raw heart health metrics into actionable information, empowering you to make informed decisions.

For active users, built-in GPS functionality enhances the experience while maintaining focus on cardiac monitoring.

These critical features guarantee you’re investing in technology that genuinely supports your heart health journey.

Setting Up AFIB Alerts on Your Smartwatch

Once you’ve selected a smartwatch with robust AFIB detection capabilities, properly configuring your alert settings becomes crucial for effective heart monitoring.

Setting up your afib alerts requires an FDA-approved device with ECG functionality and a compatible health app on your smartphone.

To get started:

• Download your manufacturer’s health app (Apple Health, Garmin Connect, etc.) and pair your devices via Bluetooth for seamless data transmission.
• Navigate through the app’s setup wizard to enable afib notifications and customize when and how you receive alerts.
• Confirm your smartwatch firmware stays updated to access the latest heart monitoring improvements.
• Position your watch snugly on your wrist for accurate readings, maintaining consistent skin contact throughout the day.

Remember to share your afib data with healthcare providers during checkups for thorough heart health management.

Sharing Smartwatch Health Data With Your Healthcare Provider

Sharing data from your AFIB-detecting smartwatch with your doctor transforms routine heart monitoring into actionable healthcare insights.

With modern smartwatches like Apple Watch, Samsung Galaxy Watch, and Fitbit, you’ll be able to sync ECG readings directly to health apps, creating detailed records of your heart activity.

Modern wearable technology transforms everyday heart monitoring into comprehensive health insights your doctor can actually use.

When your device detects an irregular heart rhythm, you can immediately save and share this critical health data with your physician. This capability enables timely intervention before conditions worsen.

Rather than trying to describe fleeting symptoms during appointments, you’ll provide tangible evidence of exactly what’s happening with your heart.

This seamless data sharing empowers you to take a more active role in your cardiac care while giving your healthcare provider the precise information needed for personalized treatment decisions.

Limitations of Smartwatch AFIB Detection Technology

While smartwatch data sharing enhances your cardiac care experience, understanding the technology’s limitations is essential for responsible use.

Even the most advanced atrial fibrillation (afib) detection smartwatches aren’t perfect diagnostic tools. Their single-electrode sensors capture less detailed data than traditional 12-lead ECGs used in clinical settings.

• Your smartwatch’s ECG algorithm may miss actual afib cases or trigger false alarms when your heart rhythm is normal.
• Physical factors like movement, skin conditions, and even your posture can compromise reading accuracy.
• Continuous monitoring might create unnecessary anxiety when you misinterpret normal variations as problems.
• Your device can’t detect acute cardiac emergencies like heart attacks, requiring traditional medical intervention.

Lifestyle Changes to Complement Your AFIB Monitoring

Beyond relying solely on your smartwatch for AFIB detection, implementing key lifestyle modifications can greatly reduce episode frequency and severity.

Adopting heart-healthy habits like consuming a diet rich in fruits, vegetables, whole grains, and lean proteins directly supports your cardiovascular system.

Commit to at least 150 minutes of moderate exercise weekly through activities like walking, swimming, or cycling to maintain ideal weight.

Minimize alcohol and caffeine consumption, as both can trigger irregular heart rhythms.

Incorporate stress management techniques such as mindfulness, yoga, or deep breathing exercises to promote relaxation and heart health.

While your FDA-approved smartwatch will help detect AFIB patterns, these lifestyle adjustments create an all-encompassing approach to managing your condition and improving long-term outcomes.

Cost Analysis: Investment in Health Monitoring Technology

Although the upfront cost of an FDA-approved smartwatch for AFIB detection may seem significant, ranging from $250 to $800, this expense represents a strategic investment in your long-term health.

Studies show that early AFib detection through health monitoring technology can reduce hospitalization rates by 30%, saving you substantial medical costs over time.

• Your $400 smartwatch detecting an irregular heartbeat before a potential $30,000 hospital stay
• The quiet vibration on your wrist that leads to life-saving early intervention
• Your doctor reviewing your ECG data remotely, eliminating unnecessary office visits
• The peace of mind when checking your heart rhythm before an important meeting

As competition increases among FDA-approved devices, you’ll likely see prices decrease, making this cost-effective health management tool even more accessible.

Future Developments: What’s Next for Cardiac Monitoring Wearables

As we look toward 2025, the landscape of cardiac monitoring wearables stands on the brink of revolutionary change.

You’ll soon benefit from non-invasive blood glucose tracking integrated with advanced ECG technology in a single device, offering extensive health insights without invasive procedures.

AI algorithms will dramatically improve the accuracy of ECG readings, making your smartwatch more reliable for detecting atrial fibrillation (AFib) and other cardiac irregularities.

Expect FDA-approved devices that not only monitor but predict potential cardiac events before they occur.

The connectivity between your wearable and healthcare providers will transform patient care through real-time data sharing.

When your watch detects irregular heart rhythms, this seamless communication will enable swift intervention—potentially saving your life through early detection and treatment.