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Only 25% of Oximeter Makers Test on Darker Skin

1/10/2025

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Summary

Story summary

A revealing study from Johns Hopkins shows a troubling reality: just 25% of pulse oximeter makers follow FDA guidelines to test their devices on diverse skin tones. This oversight, persisting since a 2013 recommendation, poses serious risks of misdiagnosis for patients with darker skin. The FDA's new draft guidance seeks to rectify this bias and enhance testing practices.

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Story summary

A revealing study from Johns Hopkins shows a troubling reality: just 25% of pulse oximeter makers follow FDA guidelines to test their devices on diverse skin tones. This oversight, persisting since a 2013 recommendation, poses serious risks of misdiagnosis for patients with darker skin. The FDA's new draft guidance seeks to rectify this bias and enhance testing practices.