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 ...
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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 ...
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Pulse Oximeters Rarely Tested on Diverse Subjects
Manufacturers increasingly but still infrequently follow Food and Drug Administration guidance that recommends testing pulse oximeters on participants ...
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Pulse oximeters may misread oxygen levels in people of color. The FDA wants to change that
The Food and Drug Administration's recommendations apply to pulse oximeters ... off the accuracy of readings. In 2021, the FDA warned doctors about potential inaccuracies with oximeters after ...
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FDA Unveils Draft Guidance to Improve Pulse Oximeter Accuracy Across Skin Tones
The FDA's recommendations apply to pulse oximeters ... doesn't regulate the vast majority of over-the-counter oximeters, most of which are considered "general wellness" devices by the agency.
New FDA rules to cut racial bias in some, but not all, devices to measure oxygen in the blood
At a CVS store in a racially diverse neighborhood in Brooklyn Center, the only devices available to shoppers to measure their ...