Amid research that has shown pulse oximeters underperform on darker skin tones, the FDA on Jan. 6 issued proposed guidance for manufacturers to improve device accuracy. Pulse oximeters ...

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 ...

A Food and Drug Administration (FDA) draft guidance would require manufacturers of pulse oximeters to gather far ...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.

The FDA's recommendations apply to pulse oximeters, which are clip-on devices used in hospitals and medical clinics to ensure patients are getting enough oxygen. The FDA said it wants companies to ...

The Food and Drug Administration’s recommendations apply to pulse oximeters, which are clip-on devices used in hospitals and medical clinics to ensure patients are getting enough oxygen.

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 ...