Years of research have showed that pulse oximeters yield less accurate readings for people with darker skin tones, and now the US Food and Drug Administration is proposing guidance to help make these ...

A Food and Drug Administration (FDA) draft guidance would require manufacturers of pulse oximeters to gather far more clinical data to show the devices accurately work across a range of skin tones.

The FDA first warned about problems with pulse oximeter accuracy in 2021. CDRH had listed draft guidance on pulse oximeters among its priorities for the 2024 fiscal year but missed the cutoff.

The common medical devices don’t work as well for Black patients. The FDA is now trying to do something about it.

The FDA announced its draft guidance on recommendations for studies assessing pulse oximeters to ensure the devices perform ...

Manufacturers increasingly but still infrequently follow FDA guidance that recommends testing pulse oximeters on participants ...

The FDA announced Monday that it has published draft guidance for manufacturers of pulse oximeters that offers recommendations for the clinical testing and labeling of these electronic medical ...