Apple Heart Study data reportedly used to win FDA approval for Apple Watch ECG
The two FDA clearances that Apple announced Wednesday for the Apple Watch Series 4's ECG capabilities came from data collected via the Apple Heart Study, according to a report Thursday.
Apple announced Wednesday at its "Gather Round" event that the new Apple Watch Series 4 comes with the ability to take an electrocardiogram -- the first Apple product to receive clearance from the FDA. Apple COO Jeff Williams said on stage that the company received the clearances for its ECG and atrial fibrillation testing on the Apple Watch via a "de novo" pathway, which means it supplied data to the agency to prove the product both worked and is safe.
Quartz reported Thursday, citing FDA documents, that the FDA used data from the Apple Heart Study in order to grant Apple those clearances. That study, conducted by Apple along with Stanford Health, launched last November and began winding down earlier this month.
The Watch's abilities don't actually mean much, according to one doctor.
Andrew Moore, an emergency department physician at the Oregon Health and Science University, told Quartz Thursday that the Series 4 doesn't rise to the level of a medical device.
"The tech that Apple is working with is very rudimentary compared to what we'd do for someone in a hospital or health care setting," Moore told the site. "The ECG thing is a little bit overhyped in terms of what it will really provide."
Apple has never quite claimed that this Apple Watch, or any other product it makes, is meant to serve as a substitute for full-fledged medical devices or professional medical attention.
It says right there on the Apple Watch, that if the Watch detects atrial fibrillation (AFib), "you should talk to your doctor." At the same time, Apple's Williams admitted that the Series 4 won't always catch AFib every time.
Apple announced Wednesday at its "Gather Round" event that the new Apple Watch Series 4 comes with the ability to take an electrocardiogram -- the first Apple product to receive clearance from the FDA. Apple COO Jeff Williams said on stage that the company received the clearances for its ECG and atrial fibrillation testing on the Apple Watch via a "de novo" pathway, which means it supplied data to the agency to prove the product both worked and is safe.
Quartz reported Thursday, citing FDA documents, that the FDA used data from the Apple Heart Study in order to grant Apple those clearances. That study, conducted by Apple along with Stanford Health, launched last November and began winding down earlier this month.
The Watch's abilities don't actually mean much, according to one doctor.
Andrew Moore, an emergency department physician at the Oregon Health and Science University, told Quartz Thursday that the Series 4 doesn't rise to the level of a medical device.
"The tech that Apple is working with is very rudimentary compared to what we'd do for someone in a hospital or health care setting," Moore told the site. "The ECG thing is a little bit overhyped in terms of what it will really provide."
Apple has never quite claimed that this Apple Watch, or any other product it makes, is meant to serve as a substitute for full-fledged medical devices or professional medical attention.
It says right there on the Apple Watch, that if the Watch detects atrial fibrillation (AFib), "you should talk to your doctor." At the same time, Apple's Williams admitted that the Series 4 won't always catch AFib every time.
Comments
With Series 4 we can at least get some sort of data, even if rudimentary, for our doctor to start from. This seems like a great capability in a device I’m already wearing every day for reasons unrelated to taking an ECG.
No, it’s a clearance. Big difference between clearance and approval.
What the Apple Watch is not
• At this point in time, the Apple Watch ECG feature is not indicated for the detection of any heart conditions except Atrial Fibrillation.
• It is also not indicated for people who already have a diagnosis of atrial fibrillation, who should be seeing a physician regularly.
• It is NOT capable of ruling in or out a heart attack. Even a full 12-lead ECG can miss certain heart attacks.
• It is also NOT considered an FDA approved medical device as some people have claimed it to be. The FDA simply released clearance letters, also known as a 510k Pre Market notification clearance, that also explicitly state that it is not intended for people under the age of 22. It is considered as an over-the-counter (OTC) device and classified as Class II, which is the same class as things like condoms and home-pregnancy kits.
• It is also not a continuous monitor of your heart's electrical activity. It is only capable of measuring an ECG while your other hand is on the crown.
◦ A single electrode ECG is also physically impossible. In order to measure electrical activity, there needs to be a complete circuit that passes through the heart. Not even a wireless device on the other hand can get around this as it wouldn't be part of the same electrical circuit.
While it is nowhere the same as the ECG in hospitals, having two separate electrodes can actually improve detection of different types of arrhythmias that was not possible with S3 or older. When arrhythmia is suspected, it's usually enough for you to go to ER. A-Fib can easily be detected with just two electrodes but requires further confirmation with more advanced ECG.
It is easy for two electrodes ECG to detect tachycardia and can tell difference between some types of tachycardias. But more electrodes are needed and placed in right places to determine what type of tachycardia it is.
You’re likely using the HTML-mode of the text editor, and not the normal WYSIWYG mode.
https://www.nbcnews.com/health/health-news/new-apple-watch-has-heart-monitor-fda-approves-n908976
If that's the case, it shows you that Apple is that good at spinning the details. They were "approved" to sell a Class II ECG device.
https://www.accessdata.fda.gov/cdrh_docs/pdf18/DEN180044.pdf
I really think those downplaying the significance of this are reprehensible. Since doctors are hard to access and will blow you off if you don’t have clear symptoms, having always present medical monitoring is one of the few things that’s actually improving in health care.
For comparison, here's a pic showing Lead II with its standard setup of the right arm and left leg. How exactly would that work with an Apple Watch? Touch your big toe to the Crown for 30 seconds?
Why are you ignoring all the irregular heart rates detected by the Apple Watch that have notified the wearer? Are you saying that none of these people could've possibly died or the Apple Watch caused even more people to die from letting them know it sensed something that should be checked out by a medical professional? Would you also tell ssomeone that condoms are pointless because you can't guarantee 100% success rate in stopping a pregnancy or STD?