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

A Food and Drug Administration (FDA) draft guidance would require manufacturers of pulse oximeters to gather far more ...

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.

Rather than relying on those testing the devices to judge skin tones, the draft guidance suggests manufacturers should use ...

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 ...

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

The Food and Drug Administration on Monday released much-anticipated testing recommendations for pulse oximeters ... the devices are tested across the range of skin pigmentations.

Pulse oximeters help doctors evaluate a person's pulse rate and the oxygen saturation of your blood. The FDA is proposing ...

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 Food and Drug Administration on Monday bolstered its recommendations for pulse oximeter testing following ... the devices in patients with wider ranges of skin tones, including from three ...

A Food and Drug Administration (FDA) draft guidance would require manufacturers of pulse oximeters to gather far more clinical data to show the devices accurately work across a range of skin tones.