Federal health officials are proposing changes to make sure medical devices that measure oxygen levels are working for ...

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A Food and Drug Administration (FDA) draft guidance would require manufacturers of pulse oximeters to gather far more ...

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

Makers of medical devices that quickly measure oxygen levels in the blood would have to gather extra data to show that their ...

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 ...

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 agency is proposing that device manufacturers improve their testing to including larger, more diverse sample sizes.

Pulse oximeters -- those tiny devices that measure blood oxygen levels with a quick clip to your finger -- may soon get a ...

Rather than relying on those testing the devices to judge skin tones, the draft guidance suggests manufacturers should use ...

The Food and Drug Administration on Monday released much-anticipated testing recommendations for pulse oximeters. The draft guidance follows years of discussion about concerns that the devices can ...

Federal health officials are proposing changes to make sure medical devices that measure oxygen levels are working for patients of color ...