Best FDA Approved ECG Smartwatches 2021 | Apple, Fitbit, Samsung ECG Watches

FDA-approved ECG smartwatches are the most suitable consumer wearables to deal with Atrial Fibrillation: a leading cause of heart strokes mainly in obese or elderly people, smokers, and those with medication conditions. 

These are powerful health tools at your disposal to keep closer tabs on your heart health. And these watches add more value to the life of old folks than young ones. 

By now, there are only a handful of watches that are approved for ECG tracking by the FDA. We will discuss them later in this post, but first, you should know the dangers of Atrial fibrillation.

According to CDC (Centers for Disease Control and Prevention)

“ Between 2.7 million and 6.1 million Americans have Atrial fibrillation.”

A more chilling estimate by CDC, 

“About 12.1 million people in the United States will have AFib in 2030.”

AFib causes about 1 in 7 strokes.”

What Precisely Is Atrial Fibrillation?

Disclaimer: I am no medical expert and have just paraphrased the CDC article for your convenience. 

Often referred to as AFib or AF, it is the most common type of treated ‘heart arrhythmia’. 

The medical jargon (heart arrhythmia) refers to the irregular heartbeat due to irregular beating of the upper chambers of the heart. It interrupts the blood flow to the lower chambers of the heart thus leading to deadly strokes. 

It may be a permanent condition or may happen in brief episodes. 

How An ECG Smartwatch Can Save Your Life?

An ECG smartwatch is not a replacement for a regular trip to the doc.

It affords you the flexibility of carrying out ECG tests when you’re out and about, at the gym or exercising or when you are at home. 

AFib and other heart conditions can come and go. An ECG smartwatch is supposed to alarm unsuspecting users just at the right time so they can get themselves checked by a physician. 

ECG smartwatches can help individuals be more aware of whether or not they should consult a heart specialist, thus saving lives by proactively detecting heart-related problems. 

Why We Have Included Only FDA Approved ECG Smartwatches?

Personal ECG devices, including ECG smartwatches, are not reliable as they are more likely to detect “False Positives” & and “False Negatives”. They are still lagging behind medical devices and are not highly accurate.

However, some ECG smartwatches are better than others. FDA approved ECG smartwatches have clearance from a robust US regulatory authority and so are better than the rest of the lot. 

Top FDA Approved ECG Watches By Apple: 

Apple released its first ECG-enabled smartwatch back in 2018 and was able to get FDA approval for it

By doing so, it spurred its competitors like Samsung, Fitbit, and Whiting to pursue the ECG feature. All of them got it in their latest smartwatches, whereas only Samsung and Fitbit were able to get FDA approval for it. 

The ECG app and irregular rhythm notification on the Apple watch require the latest version of WatchOS and iOS. As specified by the company, the smartwatch is not suitable for people under 22 years and is not a replacement for a regular trip to your physician.

To avoid ‘false positives’ and ‘False Negatives’ for people who have been previously diagnosed with Afib, Apple has clearly mentioned that irregular rhythm notification should not be relied upon. 

This resource will help you using the ECG app on Apple Watches.

The following reviews are not thorough, but are jot down with laser-sharp focus on health features and especially ECG features.

Apple Watch Series 6 (GPS + Cellular)

$499.00
$449.99
 in stock
2 new from $449.99
9 used from $361.20
Free shipping
Amazon.com
as of March 7, 2021 9:12 pm

Features & Specs:

  • eSIM: Yes
  • Size: 44mm Version
  • Weight: 47.1 g (1.66 oz)
  • OS: watchOS 7.0, upgradable to 7.1
  • Display: Sapphire crystal glass | 448 x 368 pixels (~326 PPI density) | 1.78 inches, 10.0 cm2 (~60.0% screen-to-body ratio) | Retina LTPO OLED, 1000 nits (peak)
  • Storage & Memory: 32 GB and 1 GB
  • Battery Life: Up to 18 h (mixed usage)
  • GPS: Yes, with A-GPS, GLONASS, GALILEO, QZSS
  • NFC: Yes, Apple Pay (Coverage: 41 countries worldwide)
  • Water Resistance: 50m water resistant
  • Voice Assitant: Yes, Siri
  • Fall Detection: Yes
  • Sensors: Blood oxygen sensor, Electrical heart sensor, Third-generation optical heart sensor, Accelerometer, Gyroscope, Ambient light sensor

Two Minute Review:

Apple Watch Series 6 is the latest smartwatch by the company released in 2020. It has all the excellent health, safety, and lifestyle features of its predecessor. 

Series 6 has ECG readings, irregular heart rhythm notifications, menstrual cycle tracking, fall detection, high decibel alerts, blood pressure reading,  high and low heart rate notifications, emergency SOS, and international emergency calling. Plus, it has a brand new SpO2 sensor to measure blood oxygen saturation levels. 

People with medical conditions would get the best out of the ECG feature. It has by far the most accurate sensor in consumer wearables. Also, the background heart monitor brings peace to mind. The heart rate alerts can really turn out to be a life savior.  

The smartwatch has a fall detection sensor that activates emergency call. This feature is truly helpful for elderly folks. 

Mixed usage on this watch will get you through 36 hours between charges. That includes manual ECG recording, always-on display, always-on altimeter, and sleep tracking overnight. Plus, a regular 20 minute run with onboard GPS running. The 44mm watch lasts longer than the small 40mm owing to its large battery size. 

Apple Watch Series 6 supports fast charging. Also, cordless or wireless charging is going to add a huge value to your life.

Apple Watch Series 5 (GPS + Cellular)

 out of stock
Amazon.com
as of March 7, 2021 9:12 pm

Features & Specs:

  • eSIM: Yes
  • Size: 44mm Version
  • Weight: 47.8 g (Stainless Steel Version)
  • OS: watchOS 7.0, upgradable to 7.1
  • Display: Sapphire crystal glass | 448 x 368 pixels (~326 PPI density) | 1000 nits (peak)
  • Storage & Memory: 32 GB and 1 GB
  • Battery Life: Up to 18h (mixed usage)
  • GPS: Yes, with A-GPS, GLONASS
  • NFC: Yes, Apple Pay (Coverage: 41 countries worldwide)
  • Water Resistance: 50m water resistant
  • Voice Assitant: Yes, Siri
  • Fall Detection: Yes
  • Sensors: Electrical heart sensor, second-generation optical heart sensor, Accelerometer, Gyroscope, Ambient light sensor, barometric altimeter, compass

Two Minute Review:

Apple Watch Series 5 is a cheaper alternative to Series 5 if you don’t need the SpO2 sensor, but still, need an FDA approved ECG smartwatch. The S6 chip on the Apple watch series 6 is supposed to be faster(it is in theory),  but in practice, there is no perceptible difference in performance. 

To manually take an electrocardiogram (ECG), you would have to place your finger on the crown for 30 seconds. The ECG app will show you the waveform in real-time and notify you if your heartbeat looks irregular.

For females, it has a menstrual cycle tracking feature. You will have a self-report by manually entering data in Apple Watch’s Cycle Tracking app, and the watch will predict the next period. 

The Series 6 builds on the Series 5’s success with a brighter always-on display and blood oxygen monitoring as major improvements. And if you own the Apple Watch Series 5, there is no need to get the latest one. 

The smartwatch doesn’t have sleep tracking but does come with a fall detection sensor and LTE, Wifi connectivity. The SOS calling feature comes very handy in emergency situations. 

The smartwatch promises 18 hours of battery life with the always-on display feature. However, you can turn off this feature to extend the battery life of the watch. 

Apple Watch Series 4 (GPS + Cellular)

$249.99
$225.00
 in stock
8 new from $219.99
Amazon.com
as of March 7, 2021 9:12 pm

Features & Specs:

  • eSIM: Yes
  • Size: 44mm Version
  • Weight: 47.1 g (1.66 oz)
  • OS: watchOS 7.0, upgradable to 7.1
  • Display: Sapphire crystal glass | 448 x 368 pixels (~326 ppi density) | Retina LTPO OLED, 1000 nits (peak)
  • Storage: 16 GB 
  • Battery Life: Up to 18 h (mixed usage)
  • GPS: Yes, with A-GPS, GLONASS, GALILEO, QZSS
  • NFC: Yes, Apple Pay (Coverage: 41 countries worldwide)
  • Water Resistance: 50m water resistant
  • Voice Assistant: Yes, Siri
  • Fall Detection: Yes
  • Sensors: Electrical heart sensor, First-generation optical heart sensor, Accelerometer, Gyroscope, Ambient light sensor, Barometric altimeter

Two Minute Review:

Apple Watch Series 4 was the very first smartwatch that got the FDA approved ECG sensor. It was the breakthrough advancement over the Apple watch series 3 which has cellular connectivity but not ECG. It is the cheapest Apple smartwatch with FDA approved ECG.

By assessing the mentioned features, you can easily guess that there is not a great deal of difference between Apple Watch Series 4, Series 5, and Series 6. Though we admit that Series 6 has a better display, and has a SpO2 sensor, it still doesn’t make a strong case to upgrade to the latest version. 

Other than ECG, a major health feature is the fall detection feature for old folks. The Watch will alert loved ones and EMS when you take a serious tumble. By default, this feature is enabled for people who are 65 or older.

The battery won’t get you through a day with mixed usage. With continuous GPS use, you get not more than 6 days. The watch drains the battery even faster when you use cellular connectivity or exercise. Battery performance on Apple watches is a real bummer. 

Another major drawback of Apple smartwatches is that they are only compatible with iOS devices. Let’s move forward to FDA-approved ECG smartwatches for Android users. 

Top FDA Approved ECG Watches By Samsung: 

Samsung is the top rival of Apple, but in consumer wearable, the latter has a major share of the market. (more than 30% in 2019) When Apple introduced the very first FDA approved ECG watch in 2018, it was only a matter of time before Samsung introduced its brand new watches with ECG features. 

While both the Galaxy Watch 3 and Samsung Galaxy Active 2 had ECG features for a long time, it took Samsung a while to get FDA approval for ECG tracking in the USA. The company finally get FDA approval in Sept 2020

Samsung Galaxy Watch 3

$479.99
$329.99
 in stock
20 used from $290.39
Free shipping
Amazon.com
as of March 7, 2021 9:12 pm

Features and Specs:

  • eSIM: Yes
  • Size: 45 mm Version
  • Weight: 53.8 g (1.9 oz)
  • OS: Tizen by Samsung
  • Display: 1.4″ AMOLED / 360 x 360 / 328ppi /Always-on Display
  • Storage & Memory:  8GB , 1 GB 
  • Battery Life: 20-50 hours
  • GPS: Yes with  A-GPS, GLONASS, GALILEO, BDS
  • NFC: Yes
  • Voice Assitant: Yes, Bixby
  • Water Resistance: 5 ATM  IP68 + Military Grade 8100
  • Sensors: Heart rate, Electrocardiogram, Accelerometer, Gyroscope, Barometer, Ambient light, altimeter, SpO2 

Two Minute Review:

Though Galaxy Watch 3 is the latest smartwatch by Samsung, it offers nothing out of the ordinary than the Galaxy Active 2 except for the SpO2 sensor and a large storage capacity. In terms of heart rate tracking and ECG measurement, the results are almost identical. 

SpO2 sensor in Galaxy Watch 3 tracks your oxygen levels. It’s helpful for catching conditions like sleep apnea. The Watch 3 also has advanced run coaching and sleep tracking to give post-workout and post-rest insights on how to improve.

Also, it has a physical bezel instead of a touch bezel in Active 2 to give it a traditional smartwatch touch. It is bulky and heavy. The 45mm version is suitable for those with big wrists

Galaxy Watch 3 has all the bells and whistles of a modem smartwatch. It can make calls, send texts and emails without the phone. Plus, it has a built-in GPS tracker along with NFC to allow you the freedom to leave the wallet and phone at home. You can stream music and store it on the device for offline listening. 

Samsung Galaxy Active 2

$170.70
$154.69
 in stock
11 new from $154.69
Amazon.com
as of March 7, 2021 9:12 pm
  • eSIM: Yes
  • Size: 44 mm Version
  • Weight: 42 g (1.48 oz)
  • OS: Tizen by Samsung
  • Display: 1.4″ AMOLED / 360 x 360 / 328ppi /Always-on Display
  • Storage & Memory:  4GB , 1.5 GB 
  • Battery Life: 20-50 hours
  • GPS: Yes with  A-GPS, GLONASS, GALILEO, BDS
  • NFC: Yes
  • Voice Assitant: Yes, Bixby
  • Water Resistance: 5 ATM  IP68 + Military Grade 8100
  • Sensors: Heart rate, Electrocardiogram, Accelerometer, Gyroscope, Barometer, Ambient light, altimeter

Two Minute Review:

Samsung Galaxy Active 2 is a swiss army knife of consumer wearables. The watch can switch many hats, and we have already covered it in many of the posts with different titles. This has to do with the versatile features of the smartwatch. 

The heart rate tracker of the watch is wonky as you might experience while running. But, the static reading is highly accurate. The sleep tracking sensor offers quite detail insights. Whereas, the ECG measurement is almost the same as it is in the Apple Watch.

The main difference between Samsung Galaxy Watch 3 and Galaxy Active 2 is the display. The latter has a touch bezel, is a little small in size, and has only 4 Gb storage. It doesn’t appear chunky and also has a light-weight design. 

The smartwatch can last 2 days with mixed usage. However, GPS and LTE connectivity will sap the battery, limiting the battery life to a couple of hours. Still, it is way better than Apple watch with its sleep tracking feature and compatibility with both iOS and Android devices. 

Top FDA Approved ECG Watch By Fitbit 

As mentioned earlier, Apple’s success with FDA approved ECG Apple Watch 4 spurred the competitors to have the same feature. One such competitor was the fitness-focused F.itbit. The company was taken aback by Apple encroaching their territory of health-focused consumer wearables.

Fitbit released its first health smartwatch, Fitbit Sense, which along with other cutting-edge features had the much anticipated ECG sensor. It finally got approval in Sept 2020 along with Samsung. 

Fitbit Sense

$329.95
$298.95
 in stock
12 new from $298.94
Free shipping
Amazon.com
as of March 7, 2021 9:12 pm

Features and Specs:

  • eSIM: No
  • Weight: 1.7 ounces
  • OS: Fitbit OS
  • Display:  1.58-inch OLED (336 x 336 pixels) 
  • Storage & Memory: N/A
  • Battery Life: 6 days
  • GPS: GPS and GLONASS
  • NFC: Yes (Fitbit Pay)
  • Water Resistance: 50m water resistant
  • Voice Assitant: Alexa, Google Assistant
  • Fall Detection: No
  • Sensors: Blood oxygen sensor, Electrical heart sensor, optical heart sensor, Accelerometer, Ambient light sensor, skin response sensor, Gyroscope, Altimeter

Two Minute Review:

Fitbit Sense is a proper health watch that doesn’t compromise on the bells and whistles of a smartwatch. it’s actually a health data powerhouse, brimming with sensors designed to put you in touch with the inner workings of your body and mind.

It is the only watch by the company that has FDA approved ECG sensor. The sensor will help you keep closer tabs on your heart health, especially in proactively dealing with Afib.

The smartwatch also tracks stress and informs you via a notification. It is by far the only watch that has an electrodermal activity sensor (EDA) to take fixed stress scores. The sensor keeps on training as you add manual feedback, and gets more accurate. 

It also introduced the new temperature feature to sucker punch Apple. This combined with other powerful features helps Fitbit Sense see the onset of symptoms of illness (not just COVID) among this data. However, it cannot and will not flag this for you. The data is there – but it’s for you to interpret.

Lastly, Fitbit sense has a sleep tracker and a blood oxygen saturation sensor that runs in the background when you are asleep. The sleep tracking offers some valuable insights about your sleep quality whereas the SpO2 sensor tells you how well your lungs are working. 

Watches Likely to get FDA approval:

Withing is bent over backward to get FDA approval for its two hybrid smartwatches. Both these smartwatches have ECG sensors and can perfectly take manual ECG. The watch has got CE approval (European equivalent of FDA), and therefore, it is likely to get FDA approval anytime soon.

The company claims that

“Whiting ECG detected normal sinus rhythms in patients 98.1% of times against the gold standard device and showed patients were in AFib 98.2% of times as compared to the 12-lead ECG reading.”

Withing Move ECG

Withing Move ECG, as the name suggests, is dedicated to ECG. unsurprisingly, it is the most standout feature of the watch. 

Move ECG is a health watch with no smartwatch features. It can track a number of activities other than ECG, but you will have to rely on the phone app as the hybrid watch has an analogue display. 

To take an ECG measurement, All you need to do is tap the right-side button. Keep a close look at the small activity dial. Once it hits 100 mark, place two fingers (index finger and thumb) on the metallic part of the bezel, and the activity dial will then start counting down to zero. It takes about 30 seconds. 

Alternatively you can have real-time ECG on the smartphone app. Make sure that your fingers are in the right spot on the device, the Move ECG will buzz and make you start over. 

The most convenient part of the ECG results page is the “Share PDF with your doctor” button. Clicking this generates a PDF of your ECG that you can download, email, or print out to show your doctor. 

Withing Scan Watch

Scan Watch has all the features of Move ECG, plus it has a pulse oximeter, and sleep tracking sensor to deal with sleep apnea. 

The procedure to take ECG is almost the same as in Move ECG. The Scan smartwatch has upper hand owing to its smartwatch features. It features a PMOLED display to show notifications, software menus, and health stats.

ECG Smartwatches Likely To Be Released in 2021:

The following 2 smartwatches are likely to enter the global market this year.

  1. Amazfit Verge 2
  2. Zepp Z Titanium with ECG

Both these smartwatches are manufactured by the parent company, Huami. They were released for chinese market last year, and as Huami is making its presence felt in the US market with new affordable watches, there are huge chances of these watches being available for Americans this year.

However, as Huami has not made any concrete effort to get approval by FDA for its ECG app, chances are bleak for them getting it anytime soon. 

Wrap up: 

For iOS users, all the watches are compatible, but Apple’s own smartwatches offer best compatibility. As an FDA approved ECG watch, Apple Watch Series 6 and Fitbit Sense compete neck to neck. The former might have the upper hand, Fitbit Sense attracts the users with its relatively cheaper price tag.

Fitbit Sense along with Samsung Galaxy Watch 3 and Active 2 is highly compatible with Android Phones. The Fitbit sense is a proper health watch, whereas the other two have all the bells and whistles of a standard smartwatch (cellular connectivity and big storage capacity)

Withings smartwatches may take ECG and offer attractive price points, but we wouldn’t recommend using these watches until they get FDA approval.