FDA, Pulse oximetry

FDA recommends fixing racial disparities in pulse oximeter readings
The Food and Drug Administration on Monday proposed a long-awaited plan aimed at improving how pulse oximeters work on people with darker skin — an effort that comes years after research showing the devices’ inaccuracies led to delays in covid-19 treatment for Black patients.
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 devices.
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A Food and Drug Administration (FDA) draft guidance would require manufacturers of pulse oximeters to gather far more clinical data to show the devices accurately work across a range of skin
FDA issues draft guidance to improve accuracy of pulse oximeters for people with darker skin tones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 the US Food and Drug Administration is proposing guidance to help make these devices more reliable and less biased.
FDA seeks to boost accuracy of blood-oxygen monitors across skin tones
The U.S. health regulator on Monday proposed new guidelines for widely-used blood oxygen monitoring devices to improve their performance across skin tones amid growing evidence that the current ones are not reliable for patients with darker skin.

FDA, lead and The U.S. Food

FDA Pushes to Improve Blood Oxygen Monitor Accuracy Across Skin Tones
The FDA's draft recommendations for pulse oximeters aims to include clinical studies involving at least 150 participants with ...
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