For decades, widely used pulse oximeters have underestimated the oxygen needs of darker-skinned patients. Will the FDA's new guidelines fix that?

In 2013, the FDA issued premarket guidance for developers of pulse oximeters in which it recommended that they have “a range of skin pigmentation” represented in their clinical testing of the ...

“In addition to the updated guidance on FDA cleared pulse oximeters, we believe there is a need for performance regulation of Health & Wellness-grade oximeters which constitute the vast majority ...

By comparison, the last set of recommendations around pulse oximeters, which the FDA issued in a 2013 guidance, said that studies should include at least 10 people and include at least two people ...

A Food and Drug Administration (FDA) draft guidance would require manufacturers of pulse oximeters to gather far more clinical data to show the devices accurately work across a range of skin tones.

In a 2007 draft guidance document, the FDA suggested that tests of new oximeters could “include a sufficient number of subjects with dark skin pigmentation, e.g., 30%.” ...

FDA's promised guidelines on pulse oximeters unlikely to end racial bias. Story by Guest Author • 5mo. Oakland, California — The patient was in his 60s, an African American man with emphysema.

“In addition to the updated guidance on FDA-cleared pulse oximeters, we believe there is a need for performance regulation of Health & Wellness-grade oximeters which constitute the vast majority ...

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 ...

Masimo, a company that says it has the most accurate pulse oximeters on the market, would happily comply with any FDA guidance, Daniel Cantillon, Masimo’s chief medical officer, said in an ...

(CNN) — 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 ...

Its regulatory pathway for pulse oximeters clears them for sale as long as they show “substantial equivalence” to devices already on the market. In a 2007 draft guidance document, the FDA suggested ...