Apple introduced the ECG functionality with its Watch Series 4, this feature needed FDA approval to launch with the Apple Watch but the recently added blood oxygen monitoring feature doesn’t require any such approval as Apple does not consider it as a health tracking feature.
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Pulse oximeter like the blood oxygen feature in the Apple Watch is considered as the Class II medical device that generally requires documentation. But if the feature is marketed as general awareness rather than a medical feature. In that case, FDA approval is not needed.
This must be the reason as to why this feature is not promoted by Apple as a medical feature. The Apple support document clarifies that the data recorded by the Blood Oxygen app is not for medical use rather, it is used for general fitness and wellness purpose.
As compared to the ECG functionality the blood oxygen feature works differently. The ECG feature of the Apple Watch is used to alert the users in case of abnormal heart rhythm and thus it requires greater inspection. At the time of approval, Apple was required to provide FDA with the data which proves that the feature can detect atrial fibrillation, that could be examined by experts.
Although the Blood Oxygen feature is not fully accurate as reported by some users. When compared to the finger worn oximeter the data did not match in some cases. The readings don’t seem right and sometimes suggest breathing problems to the users who don’t have any. The data seems problematic and could sometimes cause a panic situation. The Apple Watch users must not rely on this blood oxygen tracking as it is not a medical feature and may lead to panic and anxiety.
The company got permission to add blood oxygen features in more than 100 countries as compared to the ECG which is limited as it requires medical approval.
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