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FDA Proposes Diversity Requirements For Oxygen Level Devices

A health worker uses a pulse oximeter to check the oxygen saturation level of another after administering COVID-19 vaccine at a hospital in Gauhati, India, Jan. 21, 2021. (AP Photo/Anupam Nath,

A new federal proposal released by the Food and Drug Administration (FDA) on Monday targets the accuracy of pulse oximeters, devices used to measure oxygen levels in the blood. The FDA is calling for makers of these medical devices to gather additional data to ensure their effectiveness for patients of color.

Pulse oximeters are clip-on devices commonly used in hospitals and medical clinics to monitor oxygen levels in patients. By emitting two wavelengths of light into the skin when clipped onto a finger, these devices estimate the amount of oxygen flowing through the blood based on the light absorption.

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