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CBS News8mon
FDA's promised guidelines on pulse oximeters unlikely to end decades of racial bias - CBS News
For decades, widely used pulse oximeters have underestimated the oxygen needs of darker-skinned patients. Will the FDA's new guidelines fix that?
CNN5mon
FDA issues draft guidance to improve accuracy of pulse oximeters for people with darker skin tones - CNN
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 ...
Healthcare Dive5mon
FDA issues much-anticipated guidance on pulse oximeters
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 ...
The Hill5mon
New FDA guidance aims to improve accuracy of pulse oximeters for people of color - The Hill
A Food and Drug Administration (FDA) draft guidance would require manufacturers of pulse oximeters to gather far more clinical data to show the devices accurately work across a range of skin tones.
Star Tribune5mon
FDA recommends more robust testing of pulse oximeters to avoid bias in people with dark skin tone - Star Tribune
“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 ...
Oregonian8mon
Experts say new FDA guidance may not go far enough to address pulse oximeters’ racial bias - oregonlive
In a 2007 draft guidance document, the FDA suggested that tests of new oximeters could “include a sufficient number of subjects with dark skin pigmentation, e.g., 30%.” ...
Hosted on MSN8mon
FDA's promised guidelines on pulse oximeters unlikely to end racial bias - MSN
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.
KTVZ5mon
FDA issues draft guidance to improve accuracy of pulse oximeters for people with darker skin tones - KTVZ
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 ...
FierceBiotech8mon
FDA’s promised guidance on pulse oximeters unlikely to end decades of racial bias
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 ...
WHDH5mon
FDA issues draft guidance to improve accuracy of pulse oximeters for people with darker skin tones
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 ...
MM&M8mon
FDA’s promised rules on pulse oximeters unlikely to end decades of racial bias
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 ...