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The FDA announced its draft guidance on recommendations for studies assessing pulse oximeters to ensure the devices perform ...

At a CVS store in a racially diverse neighborhood in Brooklyn Center, the only devices available to shoppers to measure their blood-oxygen levels are virtually unregulated fingertip oximeters that may ...

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

FDA Calls for Better Accuracy of Pulse Oximeters in People of Color By India Edwards HealthDay Reporter TUESDAY, Jan. 7, 2025 (HealthDay News) -- Pulse oximeters -- those tiny devices that measure ...

The agency outlined what information it would like to see in premarket submissions for medical pulse oximeters, including validation of the devices’ accuracy and ensuring the devices are tested ...

A Food and Drug Administration (FDA) draft guidance would require manufacturers of pulse oximeters to gather far ... s blood oxygen levels, are less accurate on people with darker skin.

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 ...

and uses an oxygen tank at home. But her request for supplemental oxygen while hospitalized was denied, Starr said, because readings from a pulse oximeter on her finger falsely indicated that she ...

The FDA held two advisory panel meetings — in 2022 and 2024 — to discuss the accuracy of pulse oximeters and ways to improve and evaluate their performance, and the agency issued a safety ...