FDA issues draft guidance to improve accuracy of pulse oximeters for people with darker skin tones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A Food and Drug Administration (FDA) draft guidance would require manufacturers of pulse oximeters to gather far more ...
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 Proposes Changes as Pulse Oximeters May Misread Oxygen Levels in People of Color
Makers of medical devices that quickly measure oxygen levels in the blood would have to gather extra data to show that their ...
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FDA Issues Draft Guidance for Improving Skin Tone Disparities of Pulse Oximeters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Rather than relying on those testing the devices to judge skin tones, the draft guidance suggests manufacturers should use ...
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FDA Proposes Stricter Testing for Pulse Oximeters on Diverse Skin Tones
The FDA has proposed new guidelines requiring manufacturers of pulse oximeters to gather comprehensive data on device performance across various racial groups. This move aims to improve accuracy for ...
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Pulse oximeters may misread oxygen levels in people of color
Federal health officials are proposing changes to make sure medical devices that measure oxygen levels are working for patients of color ...
medtechdive2d
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 ...