Healthcare Dive

FDA issues much-anticipated guidance on pulse oximeters

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 The draft guidance follows years of discussion about concerns that the devices can be ...
Oregonian

Experts say new FDA guidance may not go far enough to address pulse oximeters’ racial bias

The patient was in his 60s, an African American man with emphysema. The oximeter placed on his fingertip registered well above the 88% blood oxygen saturation level that signals an urgent risk of ...
WHDH

FDA issues draft guidance to improve accuracy of pulse oximeters for people with darker skin tones

(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 help ...