Electrocardiogram Functionality in New Apple Watch Series 4 Models Limited to US, Coming Later This Year

Apple Watch Series 4 models include an electrical heart rate sensor that's designed to take an electrocardiogram (ECG) using an ECG app, the built-in sensor, and the electrodes included in the Digital Crown, but the ECG functionality won't be coming until later this year.

According to Apple's Apple Watch Series 4 website, the ECG app that will enable the electrocardiogram feature will be available later in 2018. That means at launch, the ECG feature won't be functional.

applewatchecgfeature
As several MacRumors readers have pointed out, it appears ECG readings are going to be limited to Apple Watch models sold in the United States. Apple Watch Series 4 pages for countries like the UK and Canada contain no mention of the feature, and Apple's press release for Series 4 models says ECG functionality is U.S. only.

To take an ECG reading from the Apple Watch, users will need to place a finger on the Digital Crown while wearing the watch. The reading is completed in just 30 seconds, allowing users to determine whether their hearts are beating in a regular pattern or if there are signs of atrial fibrillation, which can be an indicator of serious health problems.

Atrial fibrillation is a health condition that often goes undiagnosed, so the ECG feature in the Apple Watch will be highly useful for detecting early signs of disease. ECG readings also normally require a full ECG machine and a visit to the doctor, which is far less convenient than a reading taken with the Apple Watch.

Apple says that the ECG feature in the Apple Watch has been granted a De Novo classification by the FDA as outlined on the FDA's website [PDF], and the need for regulatory approval is likely why the ECG feature is not available in other countries.

De Novo FDA approval is a preliminary approval process granted to new devices that are not likely to cause harm. According to the FDA, the Apple Watch's ECG feature should be used only for informational purposes, should only be used by those over 22 years of age, and is not recommended for people with known arrhythmias.

The ECG app is a software-only mobile medical application intended for use with the Apple Watch to create, record, store, transfer, and display a single channel electrocardiogram (ECG) similar to a Lead I ECG. The ECG app determines the presence of atrial fibrillation (AFib) or sinus rhythm on a classifiable waveform. The ECG app is not recommended for users with other known arrhythmias.

The ECG app is intended for over-the-counter (OTC) use. The ECG data displayed by the ECG app is intended for informational use only. The user is not intended to interpret or take clinical action based on the device output without consultation of a qualified healthcare professional. The ECG waveform is meant to supplement rhythm classification for the purposes of discriminating AFib from normal sinus rhythm and not intended to replace traditional methods of diagnosis or treatment.

The ECG app is not intended for use by people under 22 years old.

Apple has also obtained FDA approval for the feature in the Apple Watch Series 4 models that sends notifications when an irregular heart rhythm is detected through the ECG feature or through standard Apple Watch heart rate monitoring.

All ECG data gathered by Apple Watch Series 4 models is stored in the Health app in a PDF format that can easily be shared with physicians.

Related Roundup: Apple Watch Series 6
Buyer's Guide: Apple Watch (Neutral)
Related Forum: Apple Watch

Top Rated Comments

brian3uk Avatar
35 months ago
Is anything available at launch anymore? Dual-sim nope, AirPlay 2 nope, AirPower what’s that, ECG naw, Apple Pay cash no sir, portrait mode beta. Apple has developed a bad habit it seems.
Score: 57 Votes (Like | Disagree)
OldSchoolMacGuy Avatar
35 months ago
Needs more approvals in the EU and elsewhere.
Score: 14 Votes (Like | Disagree)
baculum Avatar
35 months ago
I hope everyone knows this is pretty much worthless for 99% of users. Why don't we ALL get EKGs every day or every time we go to the doctor? because there's no reason to and it would lead to false positive diagnoses with harm caused to patients. "Should not be used for patients with known arrythmias." So this is basically for an extremely small subset of buyers who have some kind of coronary artery disease or heart pathology that makes them susceptible to possibly developing A-fib.
I understand your point, but there are myriad uses for the EKG that have great value in medical research. For example, I do research studying the EKG as a biomarker for the development of Parkinson's disease. We are working on algorithms to identify Parkinson's many years before the motor symptoms present--which would allow the intervention with disease modifying therapies at a time when they're most likely to be effective. There are numerous other examples of this, and having this type of data to mine will create amazing opportunities to identify associations with other diseases as well.
Score: 10 Votes (Like | Disagree)
rugmankc Avatar
35 months ago
What some folks are missing here is that--

1. A lot more than 1% of the US population have heart issues

2. It is a tool at the moment, not a substitute for a doctor

3. It is the future, in its early stages


Even the health features on my S0 have been useful to me.
Score: 10 Votes (Like | Disagree)
341328 Avatar
35 months ago
Crap. That sucks. Needs to come to Australia also.
Score: 10 Votes (Like | Disagree)
frankly Avatar
35 months ago
Limited to US??? Why??? This is an ESSENTIAL and sensible feature!! As someone who suffers from SVT arrhythmia this is the reason that tipped me over to buying another Apple Watch. This is utter bullsh*t. :mad:
Be patient. My guess is that there were several factors that led to this decision.

[LIST=1]
* They need to go through the regulatory agencies for each country.
* They wanted to keep this secret before announcing it and once you start going through the regulatory process, you are no longer in control of privacy.
* They need to test this close to home before opening it to a wider audience. They have to be more careful with health-related features than others.
Score: 7 Votes (Like | Disagree)

Top Stories

General Music and AirPod 3 Feature

Rumor: Apple to Announce Third-Generation AirPods and HiFi Apple Music Tier on May 18

Thursday May 13, 2021 10:32 pm PDT by
A new rumor suggests that Apple will announce the third-generation AirPods and the recently rumored HiFi, or high-fidelity Apple Music tier, on Tuesday, May 18, via a press release on its website. The new rumor comes from Apple YouTuber Luke Miani who shared the alleged exclusive news with the AppleTrack website. According to the YouTuber, Apple plans to release the next-generation AirPods...
2021 mbp hdmi slot 3d

2021 MacBook Pro Leaks Confirm Returning MagSafe and Ports

Friday May 14, 2021 3:06 am PDT by
Apple's upcoming MacBook Pro models are expected to feature a number of major changes such as larger display options and powerful new Apple silicon chips. Among the more surprising updates to this year's MacBook Pro models is the return of three ports that have been missing from the machines for over five years. Expected to come in 14- and 16-inch sizes, the 2021 MacBook Pro models are...
apple park drone june 2018 2

Apple Fires Newly Hired Ex-Facebook Product Manager Following Revelations of Past Misogynistic Comments

Thursday May 13, 2021 12:10 am PDT by
Apple has fired Antonio García Martínez, an ex-Facebook product manager and author of the controversial book "Chaos Monkeys," following public and internal calls for removal and investigation due to past misogynistic statements, The Verge reports. Apple hired Martínez earlier this week to join its ads team, however, comments that Martínez made in the past sparked condemnation from users...
magic mouse space gray discontinued

Apple Discontinuing Space Gray Mac Accessories Now That iMac Pro is Dead

Friday May 14, 2021 11:52 am PDT by
Following the discontinuation of the iMac Pro, Apple also appears to be discontinuing Space Gray "Magic" accessories that it sold separately alongside the iMac Pro. The iMac Pro was the only Space Gray Mac, and Apple designed special matching accessories for it. The Space Gray Magic Mouse 2, Magic Keyboard, and Magic Trackpad all now say "While supplies last" in small wording at the bottom...
tile amazon sidewalk integration

Apple Says Tile Trackers Sold Poorly in Apple Stores

Friday May 14, 2021 4:53 am PDT by
Earlier last month, Spotify, Tile, and Match (owner of Tinder), testified at an app store antitrust hearing spearheaded by the U.S. Senate. During the hearing, Spotify called Apple's App Store "an abusive power grab," while Tile said Apple uses its platform to "unfairly limit competition for its products." Now, in response to their testimonies, Apple's vice president and chief compliance...
google photos

PSA: Google Photos Unlimited Storage Ends Next Month, Here's How to Export Your Pictures to iCloud

Thursday May 13, 2021 5:26 am PDT by
For as long as it's existed, Google Photos has offered free unlimited storage for uploading images at a reduced yet good enough quality for most users. From June 1, 2021, however, all photos and videos uploaded to Google accounts will count against users' cloud storage. If you've been relying on Google to back up your media library, it may be time to move that content elsewhere. This article...
fortnite apple logo 2

Judge in Epic vs. Apple Case Floats Potential Compromise

Wednesday May 12, 2021 3:54 pm PDT by
In the ongoing legal battle between Apple and Epic Games, the two companies are this week calling up their expert witnesses to argue their points before Judge Yvonne Gonzalez Rogers, who will make a decision in the case after a three week trial. Expert testimony is not as exciting as some of the leaked App Store documents that were highlighted last week, especially as much of what's being...
syng cell alpha

Longtime Apple Designer Christopher Stringer's Latest Project Is a High-Fidelity Speaker With AirPlay 2

Friday May 14, 2021 7:30 am PDT by
Christopher Stringer, a key member of Jony Ive's design team who spent 21 years at Apple before departing in 2017, is resurfacing today with his new venture Syng, which seeks to make an impact in the high-end audio market. Stringer, who contributed to many of the most iconic product designs in Apple's history, announced his plans roughly a year ago, and Syng is today introducing its flagship ...
Twitter Feature

Twitter's 'Blue' Subscription Service May Cost $2.99, Will Offer Undo Tweet Option

Saturday May 15, 2021 11:08 am PDT by
Twitter has been working on some kind of subscription service since last summer, and Jane Manchun Wong, who often digs into new features coming in apps, has shared details on just what Twitter is exploring. Twitter's subscription service could be called Twitter Blue, and at the current time, it's priced at $2.99 per month. There will be a "Collections" section that allows users to save and...
imac m1 blue isolated 16x9 500k

M1 iMac is Up to 56% Faster Than Prior-Generation High-End 21.5-Inch iMac

Wednesday May 12, 2021 10:03 am PDT by
Apple's M1 iMacs are set to start delivering to customers next week, and ahead of the official launch day, benchmarks for the machines have been showing up on Geekbench, likely from reviewers who are testing them. It will come as no surprise that M1 iMac benchmarks are right on par with benchmarks for the M1 MacBook Pro, MacBook Air, and Mac mini, coming in with an average single-core score...