But many studies have revealed that pulse oximeters can measure blood oxygen levels as higher than they actually are for people with dark skin. The FDA announced Monday that it has published draft ...

The common medical devices don’t work as well for Black patients. The FDA is now trying to do something about it.

Among the wave of guidance documents issued by the U.S. Food and Drug Administration (“FDA” or the “Agency”) in the first week of 2025 were ...

A Food and Drug Administration (FDA) draft guidance would require manufacturers of pulse oximeters to gather far more clinical data to show the devices accurately work across a range of skin tones.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 Food and Drug Administration’s recommendations apply to pulse oximeters ... levels in the skin. The FDA recommendations apply to only professional oximeters used in hospitals, doctor ...

Manufacturers increasingly but still infrequently follow FDA guidance that recommends testing pulse oximeters on participants with a range of skin pigmentations, according to a new study.

It also not does address oximeters marketed as “health and wellness” devices, which typically are cheaper than FDA-cleared pulse oximeters and are sold over-the-counter. Some have criticized ...

SKOKIE, Ill., Jan. 28, 2025 /PRNewswire/ -- A fingertip pulse oximeter distributed by Concord health Supply, Inc. , a family-owned business in Skokie, is earning praise as the best in class for home ...

But many studies have revealed that pulse oximeters can measure blood oxygen levels as higher than they actually are for people with dark skin. The FDA announced Monday that it has published draft ...

The Food and Drug Administration's recommendations apply to pulse oximeters, which are clip-on devices used in hospitals and medical clinics to ensure patients are getting enough oxygen. The FDA ...