In the United States, a ban on the sale of Apple Watch with the function of measuring blood oxygen has begun

In the United States, a ban on the sale of Apple Watch with the function of measuring blood oxygen has begun

The dispute between the California companies Masimo and Apple led to a ban on the sale in the United States of smart watches Apple Watch Series 9 and Apple Ultra 2 with the function of a heart rate monitor for measuring oxygen in the blood. Apple has software disabled this feature on re-implemented instances as of January 18, 2024.

Both companies produce a smart watch. This smart watch can measure the oxygen content of the user’s blood in a non-invasive way. According to Masimo CEO Joe Kiani, Apple devices are only pretending to reliably measure blood oxygen levels and consumers are better off without such a heart rate monitor feature on the Apple Watch.

Apple disagrees with these claims. According to the company, the function of measuring the content of oxygen in the blood provides the necessary accuracy and often saves human lives.

Masimo considers the competitor’s devices inferior because Masimo’s pulse oximeter watch is approved for use by the US Food and Drug Administration (FDA), while Apple’s products are not. In addition, the Masimo smart watch continuously measures oxygen in the user’s blood, while the Apple Watch makes such measurements only twice a day. Masimo experts consider this method unreliable. The head of Masimo claims that in some cases, the continuous function of measuring this indicator is important. For example, blood oxygen saturation can decrease during sleep due to sleep apnea, a potentially dangerous condition.

Blood oxygen measurement functionality was added in 2020 to the Apple Watch Series 6. In 2021, a study by the University of São Paulo compared this Apple Watch technology to two oximeters available on the market. The study concluded that although the Apple Watch sometimes showed higher SpO2 values, the results were still fairly accurate and similar.

In 2022, another study published in the Sage Digital Health journal compared the oxygen meter in the Apple Watch to the Masimo Radical 7. According to the study, both devices showed similar results.

In addition, Apple stated that the frequency of measurements does not affect their accuracy, and the developers of the Apple Watch did not have a goal to create a device that continuously monitors the content of oxygen in the user’s blood. The accuracy of the measurements is determined by the final comparison of the results with the readings of reference devices.

Claims against 15 of Masimo’s 17 patents were previously rejected by regulators. The existing ban on the sale of the Apple Watch with an active pulse oximeter function relies on only two Masimo patents.

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