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FDA Proposes New Guidance to Address Pulse Oximeter Bias
The US Food and Drug Administration (FDA) proposed draft guidance on Monday for manufacturers of pulse oximeters to address inaccuracies in readings for people with darker skin tones, recommending diverse clinical testing and prominent warnings on devices' instructions.
FDA Proposes New Guidance to Address Pulse Oximeter Bias
The US Food and Drug Administration (FDA) proposed draft guidance on Monday for manufacturers of pulse oximeters to address inaccuracies in readings for people with darker skin tones, recommending diverse clinical testing and prominent warnings on devices' instructions.
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