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The Food and Drug Administration’s recommendations apply to pulse oximeters, which are clip-on devices used in hospitals and medical clinics to ensure patients are getting enough oxygen.

A study found that pulse oximetry overestimated the blood oxygen levels in Black children more often than in white children, according to results published in in JAMA Pediatrics.

Pulse oximeters are used to check blood oxygen saturation levels and heart rate. Research suggests that these devices may be less accurate for people with darker skin pigmentation.

Makers of medical devices that quickly measure oxygen levels in the blood would have to gather extra data to show that their products work for patients of color.

Makers of medical devices that quickly measure oxygen levels in the blood would have to gather extra data to show that their products work for patients of color.

Makers of medical devices that quickly measure oxygen levels in the blood would have to gather extra data to show that their products work for patients of color.