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 ...

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 ...

Pulse oximeters helped drive racial inequities in care during the pandemic, but many devices at drugstores and online won’t be subject to the guidelines.

The U.S. Food and Drug Administration on Jan. 6 issued new draft guidance to help improve the accuracy and performance of pulse oximeters that are used for medical purposes across populations with a r ...

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

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

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

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

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

Darker skin tones are typically the result of the presence of more of the pigment melanin, which can interfere with the absorption of light from the pulse oximeter. In practical terms, this means that ...

The FDA's draft recommendations for pulse oximeters aims to include clinical studies involving at least 150 participants with ...

The U.S. health regulator on Monday proposed a new guidance for widely used blood oxygen monitoring devices to improve their ...