The Apple Watch Series 6’s Blood Oxygen Monitor Didn’t Require FDA Approval – Here’s Why


When the electrocardiogram or ECG feature debuted on the Apple Watch Series 4, the company needed FDA approval to allow it to be functional on the wearable. With the Apple Watch Series 6 a device that sports both ECG and an oximeter, the trillion-dollar tech giant didn’t need clearance, at least for the newest feature found on the smartwatch. If you’re wondering why this is the case, a comprehensive report delivers insight which will be interesting to you.

The Blood Oxygen Monitor on the Apple Watch Series 6 Is Marketed as a ‘Wellness’, so Apple Could Skip the Clearance Step Altogether

Any company that is developing and selling Class II medical devices such as a pulse oximeters will need to obtain approval from the FDA. Additionally, any company that wants to sell one will need to make sure that the documentation describing the pulse oximeter mentions that the product works just as well as the existing versions sold in the market. Apple didn’t need to go through this arduous process. Why might you ask?

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It’s simple, there are some guidelines highlighted by the FDA that allowed Apple to bypass the approval phase. In short, FDA’s guidelines mention that if the tool is marketed as simply an instrument for measuring ‘wellness’, then a company developing the pulse oximeter won’t need to obtain clearance from the authority. Unfortunately, at the same time, Apple can’t market this feature as being able to diagnose or detect medical conditions. In fact, Apple doesn’t intend on doing so because the company has clearly stated on its Apple Watch Series 6 support page the following.

“Blood Oxygen app measurements are not intended for medical use, including self-diagnosis or consultation with a doctor, and are only designed for general fitness and wellness purposes.”

However, this doesn’t make the feature any more reliable as a previous report talked about erratic readings being displayed by Apple Watch Series 6’s oximeter, clearly confirming that you’ll need to purchase a separate oximeter if you want less confusing metrics regarding your health.

The Verge also reports that according to Michael Matheny, co-director of the Center for Improving the Public’s Health through Informatics at Vanderbilt University, the oximeter needs to serve a medical purpose.

“It’s meant to be interpreting and managing a potentially life threatening situation.”

The tipster Komiya did tweet out earlier that Apple plans to improve the functionality through software updates in the future, but it’s not confirmed if the oximeter present on the Apple Watch Series 6 will behave less erratically than before thanks to these updates. Looks like we’ll find in the future and update our readers accordingly.