Apple Watch Series 4’s electrocardiogram feature received FDA clearance just one day before ‘Gather Round’ event

“Some on the Apple Watch team may have felt their hearts pounding in the days leading up to the big Apple Watch 4 unveiling in Cupertino last week,” Mark Sullivan reports for Fast Company. “The new watch’s marquee health feature – an electrocardiogram – had not received a Food and Drug Administration clearance until within 24 hours of the device’s big coming-out.”

“I overheard an Apple employee talking about the near-miss in exasperated tones outside the Steve Jobs Theater just after the press event,” Sullivan reports. “I understood the man’s anxiety better when I saw that the FDA’s classification letters to Apple were dated September 11. Apple’s event was September 12.”

“During the presentation, Apple COO Jeff Williams proudly announced that the Watch 4’s ECG tech had received a de novo clearance from the FDA. ‘This is the first ECG product offered over the counter directly to consumers,’ he said. He wouldn’t have been able to say any of that had the FDA’s letter not come in,” Sullivan reports. “The new Apple Watch 4 will not ship with the ECG app when it goes on sale September 21. That will be added in an over-the-air update sometime later this year. The FDA classification, at least, allowed Apple to begin marketing the product.”

Read more in the full article here.

MacDailyNews Take: Phew!

Apple Watch Series 4’s electrocardiogram feature could do more harm than good – September 13, 2018
How Apple Watch saved my life – September 10, 2018
Apple Watch saves another life – August 7, 2018
Apple Watch saves yet another life – May 11, 2018
Apple Watch: How to enable Elevated Heart Rate notifications – May 8, 2018
Apple Watch saves life of New York man – May 3, 2018
Apple Watch saves Florida teen’s life – May 1, 2018
Apple Watch saves a mother and her baby after a car crash – February 16, 2018
Apple Watch saves kitesurfer stranded a mile off the California coast in great white shark-infested waters – November 13, 2017
Apple Watch saves another person’s life: ‘It would have been fatal’ – October 16, 2017
How my Apple Watch saved my life – July 25, 2016
A real lifesaver: Apple Watch saves lives – March 28, 2016
Man credits Apple Watch with saving his life – March 15, 2016
Apple Watch saves teenager’s life; Tim Cook offers thankful teen an internship – October 2, 2015


  1. Aaaaaand, the watch won’t ship with the capability. Because they’re advertising & selling things that don’t exist yet.

    Maybe it’ll ship with the AirPower. Or the open-standard Facetime. Or stereo speakers. Or Mac Pro. Or…..

    1. LOL, good one. Imagine all the things that Bill Gates promised over the years at the CES, Consumer Electronics Show, keynote addresses that never came to fruition, not just delayed, but never saw the light of day.

      Or today, think of Tesla’s FSD, Full Self-Driving. Owners pay for it, $3000 and up, but it’s been in development for years. I’m sure the accounting for that is interesting, must be counted as deferred revenue, since the functionality is “promised” for the future.

      1. I can and do imagine all the things Gates’s Microsoft and lots of other companies promised and didn’t deliver.

        My point is that I’d prefer Apple not stoop to that category. They used to UNDER promise and OVER deliver. They used to ship products that did what they advertised. The biggest fault I had with Jobs was how he would defend his products’ MISSING features. (Nobody wants apps. “Web-apps” are better. You’re holding it wrong.)

        Now not only are they shipping without features, they’re advertising the features in big presentations, then burying “will be in a later update” in fine print. They’re quietly scrubbing mentions of a long-since-announced but never-materialized product from their marketing materials.


Reader Feedback

This site uses Akismet to reduce spam. Learn how your comment data is processed.