One of the key features of the new Apple Watch Series 4 is the built-in ECG monitoring tool. According to Apple’s announcement, they claim that they were given a De Novo classification by the FDA for the feature, which allowed them to announce it at the event. However it seems that they almost couldn’t.
According to a report from Fast Company, it turns out that Apple almost did not get approval by the FDA ahead of the Apple Watch’s announcement, and we’re not talking about a wait time of days or weeks, but rather 24 hours. This meant that in the last 24 hours before the announcement, there was uncertainty as to whether or not Apple could legally announce the feature, although we all know how that turned out in the end.
That being said, it should be noted that the ECG feature of the Apple Watch will not be available at launch. Instead it is expected to arrive at a later date. Also we should point out that the Apple Watch’s ECG feature won’t be available in other markets just yet, presumably because Apple would need to clear it with the local governments and regulatory bodies like what they did with the FDA.
Hopefully it won’t take too long since it is one of the device’s key features, although for now it appears that pre-orders of the Series 4 are reportedly above expectations.