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Why Apple Watch Series 6 Blood Oxygen Monitor Did Not Require FDA Approval



Apple Watch Series 6 expands the health features of previous Apple Watch models with a new oxygen function in the blood that conveniently measures the oxygen saturation in the user’s blood, so they can better understand their general condition and well-being. Oxygen saturation, or SpO2, represents the percentage of oxygen carried by red blood cells from the lungs to the rest of the body, and indicates how well this oxygen-containing blood is delivered through the body.

The Blood Oxygen sensor uses LEDs, along with photodiodes on the back of the Apple Watch Series 6.
The Blood Oxygen sensor uses LEDs along with photodiodes on the back of the Apple Watch Series 6.

To compensate for natural variations in the skin and improve accuracy, the Blood Oxygen sensor uses four clusters of green, red and infrared LEDs along with the four photodiodes on the back of the Apple Watch to measure the light reflected back from blood. Apple Watch then uses an advanced custom algorithm built into the Blood Oxygen app, which is designed to measure oxygen in the blood between 70 and 100 percent. On-demand measurements can be performed while the user is silent, and periodic background measurements occur when they are inactive, including during sleep. All data will be visible in the Health app, and the user will be able to track trends over time to see how the oxygen level in the blood changes.

Nicole Wetsman for The Verge:

However, the features of the Apple Watch that track heart rate and heart rate have one important difference from the oxygen monitor in the blood: the heart tracking features are cleared by the Food and Drug Administration (FDA), and the oxygen monitor is not. Apple went through a long, extensive process to develop and validate an ECG function so that the watch could detect a condition called atrial fibrillation. It did not have to do the same for the pulse oximeter.

Blood oxygen monitors, or pulse oximeters, are considered by the FDA to be Class II medical devices. In general, any company wishing to sell one in the United States must submit documentation to the agency confirming that the product works as well as other versions of the same product already on the market. There is a solution, though: if the company says the product is just for fun, or for general “well-being”, they do not have to go through that process. They can not claim that it can diagnose or treat medical conditions, but they can put it up for sale.

That’s the route Apple went down … Other health-focused apps and smartwatches have taken the same approach …

MacDailyNews Take: In any case, Apple is teaming up with researchers to conduct three health studies that include the use of the Apple Watch to explore how oxygen levels in the blood can be used in future health programs.

This year, Apple will partner with the University of California, Irvine and Anthem to investigate how longitudinal measurements of oxygen in the blood and other physiological signals can help manage and control asthma.

Apple will also work closely with investigators at the Ted Rogers Center for Heart Research and the Peter Munk Cardiac Center at the University Health Network, one of the largest health research organizations in North America, to better understand how blood acid measurements and other Apple Watch calculations. can help with heart failure management.

In addition, researchers with the Seattle Flu Study at the Brotman Baty Institute for Precision Medicine and the faculty of the University of Washington School of Medicine will try to learn how signals from apps on the Apple Watch, such as heart rate and blood acidity, can serve as early signs of respiratory conditions as flu COVID-19.


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