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

A Food and Drug Administration (FDA) draft guidance would require manufacturers of pulse oximeters to gather far more ...

At a CVS store in a racially diverse neighborhood in Brooklyn Center, the only devices available to shoppers to measure their ...

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 ...

The FDA's recommendations apply to pulse oximeters ... doesn't regulate the vast majority of over-the-counter oximeters, most of which are considered "general wellness" devices by the agency.

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

A Food and Drug Administration (FDA) draft guidance would require manufacturers of pulse oximeters to gather far ... s blood oxygen levels, are less accurate on people with darker skin.

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 ...

If pulse oximeters are not calibrated for darker skin tones, the pigmentation of the skin could affect how light is absorbed by the sensor, leading to erroneous oxygen readings. Years of research ...

The FDA held two advisory panel meetings — in 2022 and 2024 — to discuss the accuracy of pulse oximeters and ways to improve and evaluate their performance, and the agency issued a safety ...