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Best FDA-Approved Smartwatch With ECG [8 Life-Saving ECG smartwatches]

Electrocardiogram(ECG) is a smart medical technology designed for checking the heart rhythm. Medical experts use electrocardiograph to measure and spot irregular heart rhythms and analyzes the data to tell if a patient has atrial fibrillation. As technology advances, so is the health care system. Today, you can conveniently, and quickly detect potential heart risks like blood clot, strokes and cardiac failure, without visiting a doctor.


By Wearing an ECG device, you can measure and determine if you have irregular heart beat, that could probably cause atrial fibrillation. Most wearables, are recently innovated to include health checking applications, and ECG happens to be a one newer addition to health-related Smartwatches.

Wearing the best smartwatch with ECG on your wrist, means you can keep track of your heart rhythm when it’s convenient for you, without the need to visit doctors. If you find that there’s an unusual ECG reading, that indicates  poor heart performance. considering time, you can quickly measure your ECG in less than a minute and send the generated report to your doctor, as a pdf copy, for further analysis.

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What is an electrocardiogram (EKG/ECG) anyway?

An electrocardiograph is a clinical investigation of a humans heart health. Physicians use the ECG procedure , to measures, or records heart rhythm so as to obtain valuable clinical data that is essential to detecting potential heart diseases.

According to the American Heart Foundation, an electrocardiograph “measures the electrical activity of heartbeat”. By measuring the intensity level of the micro electric wave and the frequency(or time) of the electrical impulse propagating from the atria to ventricles, heart experts can determine the status of the heart health.

The advancements in medical technology has made the process faster and easier in these modern times. At first, the gold standard EKG equipment was designed with 12 electrodes which could be placed around the human body, particularly around the torso and the heart.

 

best ecg smartwatch gs
Img: Best FDA Approved Smartwatch with ECG/EKG

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How does an ECG smartwatch work?

We have already got a glimpse that a clinical electrocardiograph works by detecting some micro currents right from your skin surface. Smartwatch ECG works a bit differently.

A smartwatch with a built-in ECG sensor a has sensitive-light (photo) sensors. These photo sensors uses light beam to detect changes in the blood flowing inside your finger tip or wrist.

Science calls this procedure, as a photo-plethysmograph (PPG). Since Smartwatches are high-tech wearable devices, their algorithm is able to analyze and sort out blood pressure, heart rate variability and ECG, rapidly.

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The benefits of ECG

How useful is the smartwatch ECG information? Actually, ECG offers informative clinical data about human heart. There is much that can be known by analyzing how electrical signals flow from one part of the heart(to the other. The primary purpose is that cardiologist can use this data to decide if you have risk of heart diseases or not.

But first smartwatch consumers enjoy access to a personalized heart health data and reports. At the least, individuals, can use this information in prevention and management of their medical conditions.

While ECG smartwatches help offer consumers heart rate monitoring, Electrocardiograph helps to tell health physicians about :

  •  The Blood flow within your heart,
  • The risk of thickening of the cavity walls
  • electrolytic ion imbalances. The relative quantities of electrolyte in the body, like Potassium and calcium ions determine the contractions of the cardiac muscle.
  • Actually, an ECG smartwatch offers an early detection of cardiovascular diseases , including vascular aging.

Here are other ways in which a smartwatch with an ECG is useful

 

1. Detection of Atrial Fibrillation (AFib)

Report says that atrial fibrillation – a type of heart arrhythmia, by expectation, can affect over 12 million people in the United States by 2030.

This is based on the yearly hospitalization of over 450,000 people affected by afib in the united States.

Because the prevalence rises as you age out, AFib and high blood pressure could be the worse combination in a human life.

Actually afib can be diagnosed and treated, so there is no call for panic when your ECG detects unkown conditions in your heart beat.

 

2. Detection of bradycardia or tachycardia

Bradycardia is one of the rhythm abnormalities which can be detected by an ECG smartwatch. It happens when the heart beats at a frequency under 60 beats per minute.

At that low rate, oxygenated blood is pumped from the heart at a low pressure. Distant body parts may tend to suffer for accumulation of waste and low arrival of oxygen. These generally results in a failing body system.

Tachycardia is another rhythm abnormality, where the heart rhythm goes over 100 beats per minute. The final observable signs of these heart rhythm conditions are fatigue, confusion and the difficulty to breathe due to shortness of breath.

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Advantages for gym Fans

This is where the advantage off ECG Smartwatches come in. Whether you are at the gym pounding on a treadmill with tv, or you are in an occasion, business meetings, and in the office during intense working hours, you absolutely can save your time going into the hospital for check up.

Just like blood sugars monitoring watches, and fall detection Smartwatches, patients need to constantly wear their ECG smartwatches around. Thankfully, the medical application is compatible with both iPhone and android phones.

 

Best smartwatch with ECG

Our primary criteria to pick these ECG watches was based on speed of smartwatch operating system, and the accuracy of ECG data. After all the check, analysis and comparison, we found that Samsung Galaxy watch 3 and the Apple Watch series 6 are the best smart wearables with electrocardiograph.

But there secondary considerations we made regarding choosing the best ECG smartwatch like the battery life.

Note seriously that :

Before we dive straight into ECG smartwatch review, note that they are not meant to replace professional, health expert diagnosis no replace medical equipment for electrocardiograph.

Whatever the situation, meet with your doctor, or any health specialist to fully diagnose your heart conditions. They can spot irregular rhythmic contractions of the heart, to pinpoint any potential atrial fibrillation.

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Best ECG Smartwatches for you this year

An ECG smartwatch is helpful where you can’t readily access hospital health services immediately. You could be in the mountain trailing and hiking, or you could be down the ocean diving, and doing your outdoor athletics.

ECG smartwatch would simply measure, and forward the electrocardiograph report to a health expert. But such wearable ECG watches can’t replace medical equipment.

 

 

 Samsung Galaxy Watch 3 : Best android FDA Approved smartwatch with ECG

SAMSUNG Galaxy Watch 3 (45mm, GPS, Bluetooth) Smart Watch with Advanced Health Monitoring, Fitness Tracking, and Long lasting Battery - Mystic Silver
Img : Amazon -SAMSUNG Galaxy Watch 3 – FDA Approved ECG Smartwatch


  • Connectivity :Bluetooth, Wi-Fi, NFC, GPS
  • Support: Phone, GPS, Camera,
  • Health : ECG, Heart Rate Monitor
  • Special : LTE/4G
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Samsung Galaxy 3 is powered by their Tizen operating system which us known to be pretty fast. This smartwatch actually, is built with a Larger memory capacity of 1Gb RAM.

As the latest flagship standalone smartwatch from the Samsung, the device features a very larger storage capacity up to 8Gb. What you store in this excessive internal memory, is never going to be enough.

With the Samsung health monitorand ECG app, you can readily access you ECG and reads your heart rate, oxygen level and blood pressures. Measuring your electrocardiograph is simple here.

Wear the watch on the wrist of your less dominant arm, place the finger of the other hand, on the top button, or 30-60 seconds. The Samsung ECG watch has cellular functions, and built-in sensors that will detect electrical impulse or beats as your heart pumps.

The unique feature that distinguishes Samsung Galaxy 3 from other ECG watches is the PDFs generation of the ECG report. You just need to share with family health experts, or send to hospital.

Other features on the Samsung smartwatch with ECG and blood pressure,  include

  • Installed Spotify helps In music download, streaming, playing and listening.
  • Rotating bezel helps users navigate the watch interface effortlessly. The feature first appeared in Samsung Galaxy S2.
  • This modern smartwatch with ECG also support installation off third party apps l
  • For outdoor use, this Samsung ECG watch has built-in GPS for full location, navigation.
  • Another useful feature is the NFC chip, that allows you to make wireless or contactless payments from your smartwatch. Shopping is quick and easy, just from the wrist.
  • The 18 hours battery life is a bid des outraging, as it can last the whole day when GPS is on, and music is playing. At the least, that battery
  • is enough if you seat only in the office and need to measure only your ECG every hour.
  • Takes ECG and makes a PDF of your ECG report shareable with your doctor
  • Has a Rotating bezel makes it easy navigation
  • 8GB of internal storage is enough to holds favorite songs for phone-free music listening

 

 

Samsung Galaxy Active 2 : Best FDA Approved Fitness smartwatch with ECG

SAMSUNG Galaxy Watch Active 2 (40mm, GPS, Bluetooth) Smart Watch with Advanced Health Monitoring, Fitness Tracking, and Long Lasting Battery, Aqua Black
Img: Amazon – SAMSUNG Galaxy Watch Active – Best FDA Approved ECG SMartwatch for Fitness


  • Supported Application Sleep tracking
  • Operating System Tizen OS 4.0
  • high or a low heart rate
  • Compatible : Samsung, Android
  • internal storage of 4GB
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This Samsung Galaxy 2 is the best ECG smartwatch, with slimmer, lightweight design, for fitness fanatics. Athletes and fitness enthusiast wear it to track fitness activities and workouts.

The Samsung also double the watch as smartwatch with ECG. This means the manufacturer was mindful of potential irregular heart beat amongst outdoor sportsmen and gym users.

With almost all the features o the flagship Galaxy Watch 3 we reviewed above, the uniqueness of this one comes in its design. The ECG watch has got a slimmer and lighter loops.

The thinner and sleep profile o the ECG smartwatch offers plenty of comfort, to wear unnoticeable on your wrist. Absolutely No bulk on your wrist while exercising.

Samsung watchmakers decided to cut out the bezel, as a way to achieve the slim profile. Actually, when you make comparison between these Samsung watches, the physical bezel in this Samsung Galaxy S2 is replaced with a touch-sensitive bezel.

Although the modification to touch-sensitive bezel accomplishes similar tasks, that exposes the smartwatch screen and makes it susceptible or more prone to cracks, and scratches.

Aluminum edible silicone bands just further make it one of the slimmest, smartwatch with lightweight design. It is Slimmer and lighter than Galaxy 3 and the Silicone strap is the best band material suited to exercising.

Similar to the Galaxy watch 3

  • it runs Samsung’s Tizen smartwatch operating system with a good user experience
  • Has the ability to install third-party apps,
  • It does the ECG for monitoring o your heart rhythm,
  • Has good internal storage 4Gb RAM, 8 GB storage.
  • it can be the best smartwatch or music, Spotify and Youtube.
  • Works compatibly with iPhone and android devices
  • Supports Samsung pay, smash health

 

 

 Fitbit Sense Fitness Watch : Best Health Tracking smartwatch with ECG and heart rate monitor

Fitbit Sense Advanced Smartwatch with Tools for Heart Health, Stress Management & Skin Temperature Trends, Carbon/Graphite, One Size (S & L Bands Included)
Img: Amazon – Fitbit Sense EKG Watch – FDA Approved ECG Smartwatch
  • Sleep Monitor,
  • GPS, Voice Assistant,
  • Heart Rate Monitor
  • Electrocardiograph
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( EDA Scan app detects electrodermal activity and the Fitbit ECG app is only available in select countries)

You can talk of the most premium Fitbit watches without mentioning Fitbit sense smartwatch. Fitbit is reputably known for producing fitness tracking watches, and this Fitbit sense has health tracking features like electrocardiograph, alongside its activity tracking functions.

To take you ECG with Fitbit sense smartwatch, you are required to place two fingers on the watch. This ECG measurement looks slower, as compared to Samsung ECG smartwatches.

But this is the benefits of Fitbit sacrificing time of measuring the the smart watch ECG. Fitbit is only the best smartwatch with ECG because according to reports, the Fitbit sense has a more accurate ECG sensor.

No other smartwatch that does ECG has the level of accuracy that this filibuster sense has. The report says , the Fitbit sense is an ECG sensor smartwatch that is about 98% accurate in identification of afib(atrial fibrillation) cases.

As an accurate smartwatch with ECG sensor, Fitbit is the choicest If you want to quickly detect if your heart can potentially suffer from atrial fibrillation. You know, afib is a known cause for cardiac attacks, strokes and blood clots.

Remember, you still need to go for health check, let a health expert make full diagnosis. You cannot rely on smartwatch ECG function alone.

The Fitbit Sense is the best small smartwatch for health focused fitness fanatics and sportsmen. Not all best sports watches out there can extensively track your health.

But Fitbit sense does not function only a smartwatch with ECG, it’s also a better heart rate monitor, a stress management watch , as well as an SpO2 monitoring smartwatch.

It is also the best ECG smartwatch with with blood oxygen monitoring function. Wiith these many health tracking features, sleep monitoring could be absent from the list. The watch would tell your sleep score, and fatigue based on your heart rate.

Some health metrics you would often get include the time you spend being awake or restless, the time you spent in REM sleep, and the various sleep stages.

The Fitbit Sense is one of the thinnest smartwatch with slim, sleek and lightweight design. Despite bent one of the smaller Smartwatches, it supports third party apps, and it is compatible with Strava, Android devices.

Away from the extra functionality, the battery life does not look impressive, as t lasts up to 6 days after single charge. Actually, you would get 3 straight days of regular use. To get more health data from Fitbit , subscribe for their premium health reporting with 6 months free trial and free ECG reports.

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I love this slimmer smartwatch :

  • Very Proactively to detect afib
  • Sleep tracking with daily sleep score
  • Advanced ECG and health reporting
  • Free 6 months Fitbit Premium subscription

 

Apple Watch Series 6 : Best smartwatch with ECG and blood pressure

New Apple Watch Series 6 (GPS, 40mm) - Space Gray Aluminum Case with Black Sport Band
Img: Amazon – Apple Watch Series 6 – FDA Approved Smartwatch with ECG/EKG

  • heart rhythm with the ECG app
  • Processor : S6 SiP
  • Interface:Touchscreen
  • Tracker :Sleep, Fitness & Heart Rate
  • Screen Size 40 Millimeters
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ECG is no surprise health feature coming right from apple. Amongst the apple watches, Series 6 is the high-tech smartwatch with ECG function.

Although the Apple watch series 6 ECG watch  comes at a heavier price point, considering the health benefits ranging from diabetics monitoring to sleep tracking, apple series 6 is the best electrocardiograph smartwatch to own.

The design combines both style and usability, and given the sleek, unisex, and slimmer looks, you can wear it on wrist without feeling that it’s a load. There are only 2 options, the 44 mm model and the 40 mm Apple Watch series 6.

It’s pretty easy to record your ECG on  Apple smartwatch. You need just make a finger tough on the crowd dial, to let your whole body complete the electrical circuit.

This means, that as you touch the dial, electrical signals flow through your body to track your heart’s rhythm. Just like for Samsung, the process is quite quick and takes less than 30 seconds to issue the waveform results.

Alongside the Apple Watch smartwatch ECG function, series 6 is also a fantastic tracker for heart rate, and it also serves as a pulse oximeter to monitor how saturated, oxygen is, in your blood.

Many apple fans have confirmed the ECG watch is a great lifesaver for them. But where are all these health data stored in an Apple Watch? Check the Apple Watch health app, where the health information is reported in variety of formats.

Other health and fitness features include voice assistance, onboard GPS for outdoor adventures, big storage memory for holding downloaded songs, stream and play music. It can make part of a smart home sound system.

The watch has also fall detection or seniors and people who may frequently take a hard fall. Moreover, I love this smartwatch for its standalone ability, supporting SIM card, texting and phone-free calls.

iPhone users know this watch does not work with android phones, but you can enjoy several benefits like Siri, Apple Music, Apple Pay, blue tot connectivity, wifi, and other built-in tether functions.

But apple Smartwatches don’t last longer, with weaker battery life. Apple reports 18 hours after full charge but users have confirmed the watch hardly reaches that number of hours. But there are few things you can do to extend, save, increase and improve Apple Watch battery life.

  • Accurate ECG app that displays waveform on the watch face
  • Premium look and feel with several materials to choose from
  • Smooth and fast user experience
  • Only works with iPhones

 

 

 Apple Watch Series 5 : Best Affordable Smartwatch with ECG

Apple Watch Series 5 (GPS, 40mm) - Space Gray Aluminum Case with Black Sport Band
Img: Amazon – Apple Watch Series 5 – FDA Approved Smartwatch with ECG Function
  • Always-On Retina display
  • ECG app
  • Electrical & optical heart sensors
  • Emergency SOS
  • Fall detection
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There is a more cost-friendlier Apple Watch smartwatch with ECG function, if you got no enough cash to splash on the high-end series 6 cousins.

This Apple Watch series 5 has some similar gestures as seizes 6, like the ECG function, but it comes at a lower price. While both watches are ,designed in a unisex, 44mm and 49 mm sizes, Apple Watch 5 watch has a Digital Crown with haptic feedback.

The Retina display, the variety of design featuring aluminum, stainless steel, ceramic and titanium makes Apple Watch 5 a versatile and fashionable smartwatch that suits both outdoor use, as well as fashion.

Where it comes short of functions is in the lack of pulse oximeter to check oxygen saturation in the blood, always-on-screen display, but it supports fall alert detection.

Other excellent features of this apple series 5 ECG smartwatch include

  • Fast Charging(150 minutes to get full )
  • Not very impressive battery life but you can activate battery saving feature to prolong the battery usage
  • Has good smartwatch processor, which is slower compared to model series 6
  • Supports many third party apps
  • Integrates contactless payment, for restaurants, hotels, airports and more
  • Media support include music download and streaming from Spotify, YouTube and Apple Music
  • Great as mountain hiking smartwatch
  • Measure blood sugar level for diabetics,
  • With its numerous medical features, it can serve as a better smartwatch or nurses, medical students and doctors
  • Budget friendly ECG smartwatch which is more Cheaper than the Series 6
  • Digital crown with haptic feedback
  • Compatible with Apple’s services – Apple Music and Siri

 

 

 Withings Move ECG : Best ECG smartwatch with longest Battery life


  • Brand Withings
  • Wireless : Bluetooth
  • Compatible : android phones
  • Interface :Buttons
  • Band Width :12 Millimeters
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Amongst the list o the manufacturers of Smartwatches with ECG, Withings carved out a different approach or their health wearables. They create a smartwatch, while maintaining the appearance of a more regular or traditional analog watch face.

Withings Move ECG watch is actually a hybrid smartwatch with a good list of sensors for tracking fitness and health data. The inbuilt sleep monitoring feature, and the progress motor or ones daily fitness goals are just few.

Looking at the dial of this hybrid smartwatch with ECG, you find a small dial featuring a 0-100 scale. That one is an analog step counter, a useful function for an avid treadmill runner or an outdoor mountain hiker.

Unlike all the other standalone Smartwatches we have seen above, withings move is still tightly dependent on smartphone. You can only access most features, through a paired smartphone app.

This does not mean it clan only record ECG, record you steps and do more, only when the phone is available. No, rather, the hybrid ECG smartwatch will keep tracking your core vitals without a phone, and automatically sync it up when it connects.

The device is actually not as slim as one could expect, given that it is minimal as compared to other smart watches. It is a little bulkier that Samsung Galaxy 3.

More importantly, there is no ECG smartwatch that keeps durable battery life as this Withings Move ECG. Stunningly, the battery life can last for up to 1 year(12 months) after a single charge.

Because there isn’t any power-hungry smart or touch screens, no always-on-display, no smartphone notifications, withings is the best ECG smartwatch with the longest lasting battery life. It virtually has got no sensitive screen that demands much power from the battery.

Also, if you want to have a feel of a luxury wrist watch, which still provides smart features, pick this hybrid smartwatch with ECG and get going. Don’t expect any music from it.

  • Longest lasting smartwatch battery life of 12 months
  • Budget friendly hybrid smartwatch with ECG function
  • has Limited features than other smartwatches
  • free Health Mate app (iOS and Android️)
  • Automatic walk, run, swim, bike & 10+ activities recognized. Plus calories burned & distance.
  • No smart screen

 

AliveCor KardiaMobile 6L EKG : FDA Cleared 6L EHG

FDA-Cleared 6-lead EKG
  • FDA-Cleared
  • 6-lead EKG
  • ECG measurement: 30 seconds
  • compatible: smartphones and tablets
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AliveCor KardiaMobile 6L is one of the best FDA approved smartwatches for diagnosis of atrial fibrillation and potential heart diseases. This ECG watch uses a wireless ECG tracker which can take between 30 and 60 seconds to produce your heart’s ECG.

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because this ECG monitor works wirelessly, you can mount it on any smartwatch that does not have ECG. he device is the most clinically-validated 6-lead personal EKG, to detect AFib, Bradycardia, and Tachycardia.

Using 6 leads instead of single lead in samsung and apple watches, this AliveCor EKG monitors is about 6 times accurate . The FDA-cleared wireless medical-grade EKG is compatible with most smartphones and tablets.

To measure your afib, place your fingers on the the two electrodes and touch the bottom electrode to your left leg. If you wear a smartwatch without ECG, it would read the data from the Wireless 6-Lead EKG.

The Wireless 6-Lead EKG design does more than just detect Atrial fibrillation, it can tell you about other heart problems. Unfortunately, you must pay for the premium.

Alivcor is well known for making EKG sensors , luckily, they were the first company to get an ECG accessory for the Apple Watch approved by the Food and Drug Administration.

I love this unit

  • its smaller, easily portable
  • the 6 leads ECG monitoring is insanely accurate
  • Compatible with iOS and Android devices
  • good battery life
  • you have advantage to subscribe for doctor ECG interpretation
  • ECG report is shareable

 

Withings ScanWatch : Best Hybrid smartwatch with ECG

The better alternative to Withings move ECG are the Withings HR and the Scanwatch Smartwatch. The Scanwatch is a really a hybrid-style smartwatch, with an analog watch face.

The minimalist watch face just displays basic information like heart rate, and step count, but it comes packed with many features.

The hybrid smartwatch comes with a medical-grade ECG, a heart rate sensor, and a blood oxygen pulse oximeter.

To check your ECG, place your finger on the watch bezel for up to half a minute. The watch tracks your heart rhythm and issues a report. Unfortunate, as the hybrid watch screen looks pretty smaller, the ECG recording is not clearly viewable.

That is why you are going to need a smartphone to track such data collected. It is Limited when compared to other smartwatches. You should not also expect from this hybrid watch , an NFC payment, built-in GPS and map navigation features to track runs.

Slightly better than other standalone smartwatch like apple, this Withings ScanWatch has got a decent 30-day battery life. This is not an impressive battery life duration, as compared to 12 months for Withings Move ECG.

 

Amazfit Verge 2 –  Budget friendly smartwatch with ECG function

Amazfit GTS 2e Smartwatch with 24H Heart Rate Monitor, Sleep, Stress and SpO2 Monitor, Activity Tracker Sports Watch with 90 Sports Modes, 14 Day Battery Life, Purple
  • Supported: Fitness Tracker, , Heart Rate Monitor
  • Connectivity: Wireless, Bluetooth
  • Operating System: Amazfit OS
  • Human Interface: Touchscreen
  • Water Resistant

Amazfit GTS 2e Smartwatch is our last health smartwatch packed with ECG , 24H Heart Rate Monitor, Sleep, Stress and SpO2 Monitor, and Activity Tracker for Sports . You also get about 90 Sports Modes, and a 14 Day Battery Life,

The smartwatch is equipped with the Huami-developed BioTracker 2, the second-generation PPG bio-tracking optical sensor.

Even whilw running outdoor or cycling a bike, this Amazfit GTS 2e can provide you, a 24-hour heart rate monitoring, SpO2 measurement, and sleep quality and stress level monitoring.

At a cost-friendlier price, you can do screening of your heart arrhythmia and atrial fibrillation. Unfortunately, this ECG smartwatch has only been approved in China FDA. US and Europe are still pending.

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Are smartwatch ECGs accurate?

There is some concerns about ecg smartwatch accuracy but First, can a smartwatch diagnose heart attack?

Yes, the smart watch generated ECG, according to reports at Harvard health, are about 93% to 95% accurate at detecting, identifying, and distinguishing heart attacks, for people already having heart problems. This accuracy is quite different for healthier people, as the watch’s ECG accuracy stood at 90% signifying no heart attack.

However, a Smartwatch ECG, is of course, not as accurate as a clinical 12-lead electrocardiogram. Yet, they offer very informative data which can potential lead to deadly heart-health troubles.

For example, Apple Watch from Series 4, 5 and 6 use one-lead electrode for their ECG measurement. It technically Combines both electrical signals and wrist photoplethysmography to provide a greater reliability and an improved ECG accuracy.

Another ecg watch like AliveCor KardiaBand uses a single-lead EKG. As tested and proven by Dr. Kajakariar, Box Hill Hospital, Australia, this one lead ECG has more clinical benefits, with moderate diagnostic accuracy.

Even if your smartwatch alerts irregular heart performance, your heart still needs to be checked and if there are issues, they are addressed by cardiologists . They have very sophisticated instruments for that purpose.

In fact, the best recommendation is that you should not keep waiting because a chronic disease to progress silently. If you pick your own ECG smart device, it holds the potential to ring alarm when your hear beats irregularly. A a smartwatch with EKG is potentially your life saver.

Time is a very critical factor in cardiology. Heart issues that are promptly treated at early stages can add several decades to your age.

 

 

Understanding an FDA-approved and FDA-cleared ECG smartwatch

To protect the health of the United States citizens, Food and Drug Administration (FDA) evaluate and regulate medical products to make sure they don’t be of potential health risk for people.

With the rigorous FDA regulatory process , getting a medical device approved isn’t an easy task. You know, the manufacturers need to submit how the medical device performs – results of the clinical test conductor on the product.

Europe and United States don’t follow the same pathways to getting formal approval. So it’s possible that some ECG Smartwatches can be approved in Japan and Europe, but not approved by FDA in U.S.

That also explains why there are not many medical Smartwatches in the market, as compared to GPS Smartwatches, in the market. I guess manufacturers or pharmaceutical laboratories in America needs a lot of patience.

Getting clearance on a medical device may creates risks of manufacturers using old predicates. Do it’s perfect a product be formally approved base on the clinical studies made about it. The big problem with health Smartwatches is that independent trials take a lot of time to be conducted.

 

Pros and Cons of ECG smartwatches

Back in 2018, American Heart Foundation acknowledged that new wearable technologies related to health, like EKG watches are absolutely be beneficial for patients with heart diseases. But there are some disadvantages

  •  Price is higher, which then limits accessibility to help determine the health of many.
  • a false positive or false negative may occur , leading to more stress and or a non-justified relief.
  •  Smartwatches have potential breach of privacy even with HIPAA compliance.
  • Although they are helping, but there is risk of clinical unreliability with the use of PPG or single-lead EKG.

 

Wrap Up

Wearing a smartwatch with ECG everyday, would be an efficient and timely way to track anomalies in your heart rhythm. The most interesting aspect of having an ECG smartwatch is that you get to analyze your heart beat pattern anytime and anywhere.

ECG Smartwatches are not meant to replace medical tools and expert advice. So while you wear your smart watch with ECG, consult your physician or cardiologist for clinical and diagnostic analysts, immediately you observe irregular heart functions.

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