The FDA Weighs in (Again) on Biased Pulse Oximeters In January, the FDA released new draft guidance for makers of medical devices that measure blood oxygen levels. This data can help determine whether a patient needs treatment, but the devices are not as reliable when used on people with dark skin tones. The new guidance calls for more inclusive clinical trials.
https://undark.org/2025/02/05/....fda-biased-pulse-oxi