FDA reviews pulse oximeter accuracy in darker skin tones due to light absorption concerns.

The Food and Drug Administration (FDA) is reviewing the accuracy of pulse oximeters for people with dark skin tones. An FDA advisory panel met on February 3, 2023, to discuss ways to improve the accuracy and performance of these devices for individuals with darker skin. Pulse oximeters are fingertip clamps that use light beams to estimate oxygen saturation and pulse rate. Research has shown that darker skin pigmentation can affect light absorption by the sensors, leading to inaccurate results and potentially delayed care or missed diagnoses.

February 02, 2024
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