According to reports, the Apple Watch Series 4 got FDA classification letters on September 11, while the launch event was on September 12.
It looks like Apple came very close to delaying the launch of the Watch Series 4. According to a report by FastCompany, the Watch’s FDA classification letters were sent to Apple on September 11, while the launch was on September 12. Any further delay to those letters, and there could have been a very good chance that Apple would have to delay the launch of the Watch Series 4 as the ECG features was one of the main highlights of the device.
During the presentation, Apple’s COO, Jeff Williams announced that the the Watch Series 4’s ECG Technology had received clearance from the FDA. Without those letters, he wouldn’t be able to say that. An ECG detects irregularities in a person's heartbeats (arrhythmias) and any such device requires approval from the FDA, at least in the US.
The report notes that the FDA didn’t check the ECG hardware of the smartwatch, but rather two apps. The first app is called the ‘Irregular Rhythm Notification Feature’ and looks at the Apple Watch wearer’s heartbeat rhythm and can send a notification if it detects patterns related to atrial fibrillation or some other arrhythmia.
The second app is called the electrocardiograph software for over-the-counter use by the FDA and it creates an electrocardiograph and provides analysis on whether it shows signs of cardiac arrhythmias. However, as per the report, the device is not intended to provide a diagnosis.
FastCompany’s report goes on to state that the FDA has also put clear limitations on how the app should be used. “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 should be noted that when the app goes on sale in the US on September 21, it will not come with the ECG app. This will be provided via an OTA update. Further, the app is only available in the US, and it’s quite possible that the company is waiting for approval from each countries respective medical authorities before bringing the feature to the the Watch Series 4 in other countries.
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