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

Sleep apnea affects millions of people worldwide and prevents them from getting quality sleep. It negatively affects patients’ overall health. Diagnosing sleep apnea is the first step toward proper ...

The FDA announced its draft guidance on recommendations for studies assessing pulse oximeters to ensure the devices perform ...

Pulse oximeters measure the amount of light that passes through the skin as a way to estimate how much oxygen is in a patient’s red blood cells. Melanin, which absorbs light that passes through ...

The Food and Drug Administration on Monday released much-anticipated testing recommendations for pulse oximeters. The draft guidance follows years of discussion about concerns that the devices can ...

(CNN) — 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 ...

Opens in a new tab or window There was "low but improving uptake" of reporting about the diversity of participants in summary documents for FDA-cleared pulse oximeters after voluntary guidance was ...