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US regulator proposes special labelling for pulse oximeters that work on all skin colours

The US Food and Drug Administration (FDA) has published draft guidance aimed at improving the performance of pulse oximeters across all skin colours, following research suggesting the medical devices may be less accurate in people with darker skin.1

Once finalised, the guidance could see a prominent label added to the packaging of pulse oximeters proven to perform “comparably across groups of individuals with diverse skin pigmentation.”

It also provides manufacturers with actions they can …

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