MedTech Dive February 5, 2024
Studies have found that pulse oximeters overestimated oxygen saturation in people with dark skin pigmentation, resulting in delayed care.
The Food and Drug Administration convened an advisory panel on Friday to discuss concerns that pulse oximeters may be less accurate in people with dark skin pigmentation.
The agency asked panelists for their thoughts on new clinical trial requirements to ensure the devices are accurate across all skin tones and whether prescription and over-the-counter pulse oximeters should be held to the same standards.
The scope of the problem
The FDA issued a warning in 2021 that pulse oximeters pose a “risk of inaccuracy under certain circumstances,” and a group of attorneys general last year urged the agency to “act with urgency”...
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