Following the FDA’s release of a guidance requesting more diversity in pulse oximeter testing, the number of clearance ...

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 US Food and Drug Administration is proposing guidance to help make ...

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

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 ...

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

A Food and Drug Administration (FDA) draft guidance would require manufacturers of pulse oximeters to gather far more clinical data to show the devices accurately work across a range of skin tones.

Makers of medical devices that quickly measure oxygen levels in the blood would have to gather extra data to show that 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 Food and Drug Administration on Monday bolstered its recommendations for pulse oximeter testing following public uproar over how inaccurate readings led to different medical care for patients ...