Years of research have showed that pulse oximeters yield less accurate readings for people with darker skin tones, and now the US Food and Drug Administration is proposing guidance to help make ...
In 2013, the FDA issued premarket guidance for developers of pulse oximeters in which it recommended that they have “a range of skin pigmentation” represented in their clinical testing of the ...
The Food and Drug Administration on Monday bolstered its recommendations for pulse oximeter testing following public uproar over how inaccurate readings led to different medical care for patients ...