But many studies have revealed that pulse oximeters can measure blood oxygen levels as higher than they actually are for people with dark skin. The FDA announced Monday that it has published draft ...

The common medical devices don’t work as well for Black patients. The FDA is now trying to do something about it.

The FDA first warned about problems with pulse oximeter accuracy in 2021. CDRH had listed draft guidance on pulse oximeters among its priorities for the 2024 fiscal year but missed the cutoff.

Among the wave of guidance documents issued by the U.S. Food and Drug Administration (“FDA” or the “Agency”) in the first week of 2025 were ...

A Food and Drug Administration (FDA) draft guidance would require manufacturers of pulse oximeters to gather far more clinical data to show the devices accurately work across a range of skin tones.

Pulse Oximeters May Misread Oxygen Levels in People of Color. the FDA Wants to Change That WASHINGTON (AP) — Makers of medical devices that quickly measure oxygen levels in the blood would have ...

But many studies have revealed that pulse oximeters can measure blood oxygen levels as higher than they actually are for people with dark skin. The FDA announced Monday that it has published draft ...

The Food and Drug Administration’s recommendations apply to pulse oximeters ... levels in the skin. The FDA recommendations apply to only professional oximeters used in hospitals, doctor ...

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 ...