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FDA issues draft guidance to improve accuracy of pulse oximeters for people with darker skin tones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A Food and Drug Administration (FDA) draft guidance would require manufacturers of pulse oximeters to gather far more ...
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FDA Issues Draft Guidance for Improving Skin Tone Disparities of Pulse Oximeters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.
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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 get a ...
STAT1d
FDA releases long-awaited guidance to improve accuracy of pulse oximeters for all skin tones
Rather than relying on those testing the devices to judge skin tones, the draft guidance suggests manufacturers should use ...
STAT9d
Fixing pulse oximeters requires federal might and possible legal action, researchers say
Work by device manufacturers to improve the performance of pulse oximeters on people with darker skin has progressed little since the Food and Drug Administration asked manufacturers in 2013 to ...
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Diversity Reporting Improved in Pulse Oximetry Testing After FDA Guidance
Opens in a new tab or window There was "low but improving uptake" of reporting about the diversity of participants in summary documents for FDA-cleared pulse oximeters after voluntary guidance was ...
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FDA issues much-anticipated guidance on pulse oximeters
The FDA released the guidance in response to concerns that the devices are less accurate in people with darker skin ...