Pulse oximeters may misread oxygen levels in people of color. The FDA wants to change that
Federal health officials are proposing changes to make sure medical devices that measure oxygen levels are working for ...
FDA issues draft guidance to improve accuracy of pulse oximeters for people with darker skin tones
Years of research have showed that pulse oximeters yield less accurate readings for people with darker skin tones, and now ...
FDA recommends more robust testing of pulse oximeters to avoid bias in people with dark skin tone
New draft guidelines would increase the number of people with darker skin who should be included in clinical trials of the ...
New FDA guidance aims to improve accuracy of pulse oximeters for people of color
A Food and Drug Administration (FDA) draft guidance would require manufacturers of pulse oximeters to gather far more ...
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Study: Only 25% of pulse oximeters tested for skin-tone bias post-FDA guidance
These devices, crucial for measuring blood oxygen levels, have shown discrepancies in accuracy when used on darker skin, leading to potential health risks for non-white patients, the study states ...
TCTMD2d
FDA Issues Draft Guidance for Improving Skin Tone Disparities of Pulse Oximeters
The agency is proposing that device manufacturers improve their testing to including larger, more diverse sample sizes.
CNN4d
FDA issues draft guidance to improve accuracy of pulse oximeters for people with darker skin tones
But many studies have revealed that pulse oximeters can measure blood oxygen levels as higher than they actually are for people with dark skin. The FDA announced Monday that it has published draft ...
healthday on MSN3d
FDA Calls for Better Accuracy of Pulse Oximeters in People of Color
Pulse oximeters -- those tiny devices that measure blood oxygen levels with a quick clip to your finger -- may soon ge ...
Star Tribune4d
FDA recommends more robust testing of pulse oximeters to avoid bias in people with dark skin tone
It also not does address oximeters marketed as “health and wellness” devices, which typically are cheaper than FDA-cleared pulse oximeters and are sold over-the-counter. Some have criticized ...