Acknowledging the disparity in pulse oximetry implicates a $2 billion industry that has faced stricter regulations in recent ...

Darker skin tones are typically the result of the presence of more of the pigment melanin, which can interfere with the absorption of light from the pulse oximeter. In practical terms, this means that ...

New draft guidelines would increase the number of people with darker skin who should be included in clinical trials of the ...

"The most important finding is that although there were more mentions of skin color descriptors in performance testing after ...

Pulse oximeters help doctors evaluate a person's pulse rate and the oxygen saturation of your blood. The FDA is proposing ...

Years of research have showed that pulse oximeters yield less accurate readings for people with darker skin tones, and now ...

The FDA has published a set of long-awaited recommendations to the industry to help ensure that pulse oximeters work correctly across all skin tones. | The FDA has published a set of long-awaited ...

Opens in a new tab or window There was "low but improving uptake" of reporting about the diversity of participants in summary documents for FDA-cleared pulse oximeters after voluntary guidance was ...

These devices, crucial for measuring blood oxygen levels, have shown discrepancies in accuracy when used on darker skin, leading to potential health risks for non-white patients, the study states ...

Manufacturers increasingly but still infrequently follow Food and Drug Administration guidance that recommends testing pulse oximeters on participants with a range of skin pigmentations, according to ...

Manufacturers increasingly but still infrequently follow Food and Drug Administration guidance that recommends testing pulse oximeters on participants ...