Stephen Silver
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.
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40 Comments
I think an important part that people are overlooking is that if I have a Series 4 AND feel/am notified that something is off I can’t take an ECG and save the data which I can then share with my doctor (hopefully). The president of the AHA mentioned he typically has patients report symptoms that aren’t present during an appointment.
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.
Apple is not the first to get FDA approval... I have been using Kardia band (alivecor) for almost half a year now. What Apple is doing is making it seamlessly integrated into apple watch instead of an accessorized band.