With several branded smartwatches claiming to read accurate blood oxygen levels on the market, the US Food and Drug Administration (FDA) has raised fresh concerns over pulse oximeters that monitor blood oxygen levels in hospitals and at home. According to an FDA advisory panel, blood oxygen monitors need to be more carefully regulated as they do not work as well on people with darker skin tones.

The advisory committee reviewed multiple research studies that showed the ineffectiveness of oximeters on darker skin. One such study revealed that the treatment of black patients was delayed because the devices did not show dropping oxygen levels.

Earlier, in 2021, during the pandemic, the FDA issued an alert saying that these devices have "limitations" based on the results of a study published in December 2020. The study revealed an increased risk for missed diagnosis of "occult hypoxemia," causing a delay in treatment eligibility decisions and worse patient outcomes among subjects with darker skin pigmentation. 

(Source: https://www.daijiworld.com/news/newsDisplay?newsID=1016415 )