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“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.
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