Device Advisors Back FDA Efforts To Detect Bias In Pulse Oximeters

By Jessica Karins / February 5, 2024 at 5:59 PM
FDA appears likely to move toward a requirement for pulse oximeter manufacturers to demonstrate their devices do not have poorer performance for patients with darker skin tones, following an advisory committee meeting in which the agency’s advisors and members of the public expressed approval of FDA’s proposed approach. The anesthesiology and respiratory therapy devices panel of the FDA’s Medical Devices Advisory Panel met Friday (Feb. 2) to discuss the issue of pulse oximeter bias based on skin pigmentation, a problem...


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