mHealth Intelligence November 13, 2023
Anuja Vaidya

In a letter, state AGs highlighted research showing that pulse oximeter readings are often inaccurate for populations of color, urging the FDA to take action.

A group of state attorneys general (AGs) has sent a letter to the United States Food and Drug Administration (FDA) urging the agency to address the issue of pulse oximeter inaccuracies when used on people with darker skin tones.

AGs from 25 states, including California, Arizona, Colorado, Utah, Michigan, and Ohio, noted in the letter that it has been one year since the FDA convened a public meeting to address concerns about race and color bias associated with pulse oximeter use. However, since then, these devices have continued to be sold without clear label warnings...

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Topics: FDA, Govt Agencies, Medical Devices, States
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