Pulse oximeters may misread oxygen levels in people of color. The FDA wants to change that
- The FDA proposed that makers of medical devices must gather extra data to ensure their products work for patients of color.
- The FDA warned in 2021 that oximeters tended to overestimate Black patients’ oxygen levels, risking delays in treatment and increased death rates.
- The draft recommendations require companies to enroll at least 150 patients of different skin tones in clinical studies.
- The FDA will accept public comments on its proposal for 60 days before finalizing it.
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Leaning Left8Leaning Right2Center38Last UpdatedBias Distribution79% Center
Bias Distribution
- 79% of the sources are Center
79% Center
L 17%
C 79%
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