FDA approval landed only a few hours before the launch

Sep 19, 2018 09:57 GMT  ·  By

The Apple Watch Series 4 was one of the biggest stars of Apple’s September 12 event when the company also introduced the new iPhones, mostly because of the ECG tech that comes built-in.

With the electrocardiogram feature, Apple Watch can theoretically help detect arrhythmias, so the device required clearance from the Food and Drug Administration.

And while Apple did receive the go-ahead for the ECG system on the Apple Watch, it looks like the FDA approval was offered only a few hours before the launch event.

A report from Fast Company reveals that FDA’s documents sent to Apple for ECG clearance were dated September 11, whereas the official launch took place on September 12 early in the morning.

Executives at the Cupertino-based company bragged about the FDA approval during the conference, but the cited source emphasizes that none of these would have been possible if the FDA documents hadn’t been issued on September 11.

No ECG on Apple Watch models sold elsewhere

The FDA clearly states in its documents that the ECG system on the Apple Watch shouldn’t take any clinical action based on the data issued by the device.

“The ECG data displayed by the ECG app is intended for informational use only. The user is not intended to interpret or take clinical action based on the device output without consultation of a qualified healthcare professional. The ECG app is not intended for use by people under 22 years old,” it says.

The last-minute approval, however, means Apple can’t yet release the ECG feature on the Apple Watch Series 4 in the United States, and the company says that such functionality would arrive at a later time with a software update.

At the same time, ECG is also missing from the Apple Watch models sold in other countries, as Apple also needs clearance from local authorities as well.

In other words, ECG will be a US-exclusive feature for now, but sooner or later, Apple should receive similar approval from different organizations across the world too. This means ECG on the Apple Watch Series 4 may be released to other markets as well, though no specifics on timing can be provided right now.