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Why doesn’t Apple need the FDA to approve the blood oxygen tracking function of its Apple Watch Series 6?



According to foreign media MacRumors, before releasing the ECG function in Apple Watch Series 4, Apple needs the US Food and Drug Administration (FDA) to approve the function, But the blood oxygen monitoring function in Apple Watch Series 6 is different, because Apple does not think this is a medical function.

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As The Verge introduced, pulse oximeters such as the blood oxygen tracking function in Apple Watch are considered to be the second type of medical equipment, and related documents are generally required, but there is also a way. If the pulse oximeter is marketed as being used for general health or recreation, and not for medical purposes, the FDA does not need to provide documentation.

This is also the reason why the blood oxygen tracking function has not been promoted by Apple as a medical function. Apple’s support document clearly states that the measurement using blood oxygen tracking is “not for medical purposes” and is designed for “general fitness and health purposes.” of.

The Apple Watch Series 6 blood oxygen application does not provide insight into blood oxygen readings, nor does it sound an alarm when blood oxygen levels are lower than normal, because that is a medical function.

Apple prohibits the use of blood oxygen tracking to affect the medical services someone receives, which is different from the way the ECG function works. The ECG reading of the watch is used to remind the user of abnormal heart rhythms (atrial fibrillation), so it is necessary to strengthen supervision. Apple is required to provide data to the FDA to prove that the function can detect atrial fibrillation, and these data can be checked by experts.

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Foreign media believe that by avoiding regulatory approvals in the United States and other countries, Apple was able to introduce blood oxygen functions in more than 100 countries. The availability of the ECG is still limited because it requires medical approval to be launched in each country.

Michael Matheny, co-director of Vanderbilt University’s Center for Informatics for the Improvement of Public Health, told The Verge that when he went to look for data on the operation of the pulse oximeter in the Apple Watch, there was not much information. “It worries me,” he said.

This may also confuse customers, because Apple’s marketing is sometimes unclear. “Patients and consumers don’t really understand the difference between the two,” Matheny said. “So they will start using equipment and rely on information.”

There are multiple reports from Apple Watch Series 6 users that show that compared with ordinary pulse oximeters, the blood oxygen tracking function is not particularly accurate, and continuous readings may be everywhere.

MacRumors also noticed the problem of abnormal readings. These readings do not seem to be correct, but suggest breathing problems when there is no problem. This is a potential problem and may cause panic of doing nothing. This function is also difficult to use, requiring very little arm movements, and the result may be affected by factors such as cold weather and tattoos. However, MacRumors pointed out that some users are not facing the problem. All Apple Watch Series 6 users should remember that blood oxygen tracking is not a medical function and should not be relied on to measure health, even if it may have a certain degree in an emergency. Warning function.