Healio

FDA panel: Pulse oximeters show clear ‘disparate performance’ for darker skin pigmentation

At a Medical Devices Advisory Committee meeting held Nov. 1, panelists recommended improvements to the FDA regarding pulse oximeters and their accuracy among patients with darker skin pigmentation.
Healio

FDA panel: Proposed changes to pulse oximeter premarket studies generally well received

Please provide your email address to receive an email when new articles are posted on . The FDA’s proposed changes to premarket pulse oximeter trial criteria were generally accepted by an advisory ...
CNN

FDA panel recommends more diversity in pulse oximeter trials

The longstanding problem of pulse oximeters providing less-accurate readings for people with dark skin tones got another look Friday from a panel of experts for the US Food and Drug Administration.
Healthcare Dive

FDA panel recommends new standards for pulse oximeters amid bias concerns

The Food and Drug Administration convened an advisory panel this month to discuss concerns that pulse oximeters may be less accurate in people with dark skin pigmentation. The agency asked panelists ...