Years of research have showed that pulse oximeters yield less accurate readings for people with darker skin tones, and now the US Food and Drug Administration is proposing guidance to help make these devices more reliable and less biased.

Rather than relying on those testing the devices to judge skin tones, the draft guidance suggests manufacturers should use both the newly developed Monk Skin Tone scale and another scale, called the individual typology angle (ITA), which is based on spectrophotometric measurements.

Following the FDA’s release of a guidance requesting more diversity in pulse oximeter testing, the number of clearance summary documents discussing race and ethnicity/skin tone rose, according to a research letter published in JAMA.

Pulse oximeters help doctors evaluate a person's pulse rate and the oxygen saturation of your blood. The FDA is proposing changes to make them more accurate.

Makers of medical devices that quickly measure oxygen levels in the blood would have to gather extra data to show that their products work for patients of color, under a new federal proposal released Monday.

A Food and Drug Administration (FDA) draft guidance would require manufacturers of pulse oximeters to gather far more clinical data to show the devices accurately work across a range of skin tones. The long-awaited guidance released Monday comes in response to mounting evidence that the devices,