FDA Considering Race, Ethnicity In Pulse Oximeter Performance

By Luke Zarzecki / November 20, 2023 at 6:31 PM
FDA’s device center is considering a new approach to pulse oximeters that would factor a patient’s skin pigmentation and patient-reported race and ethnicity when weighing the strength of premarket studies and other methods to evaluate performance of the technology. The news came in a Monday (Nov. 20) announcement of another public meeting of FDA’s advisers on pulse oximeters and various studies highlighting discrepancies in care due to inaccurate pulse oximeter readings for people of color. FDA also published a discussion...

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