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

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 these ...

The FDA announced its draft guidance on recommendations for studies assessing pulse oximeters to ensure the devices perform ...

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 CDRH had listed draft guidance on pulse oximeters among its priorities for the 2024 fiscal year but missed the cutoff.

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 FDA said ...

Draft recommendations from the FDA call for larger, more inclusive studies to ensure pulse oximeters work for people with ...

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 ...