Problems with pulse oximeters have been known for decades, but it wasn’t until the pandemic that the real dangers to Black ...

Individuals with darker skin tones may have difficulty using certain medical equipment according to recent studies.

The FDA announced its draft guidance on recommendations for studies assessing pulse oximeters to ensure the devices perform ...

[On January 6], the U.S. Food and Drug Administration published new draft guidance aimed at helping improve the accuracy and ...

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 ...

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The U.S. Food and Drug Administration on Jan. 6 issued new draft guidance to help improve the accuracy and performance of pulse oximeters that are used for medical purposes across populations with a r ...

The Food and Drug Administration’s recommendations apply to pulse oximeters, which are clip-on devices used in hospitals and ...

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 ...