WASHINGTON, D.C. – The Food and Drug Administration (FDA) is warning that the pulse oximeters that have become essential tools in the fight against COVID-19 may not work as well on people of color. A ...

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 The draft guidance follows years of discussion about concerns that the devices can be ...

A Food and Drug Administration (FDA) draft guidance would require manufacturers of pulse oximeters to gather far more clinical data to show the devices accurately work across a range of skin tones.

The FDA has published a set of long-awaited recommendations to the industry to help ensure pulse oximeters work correctly across all skin tones. The agency’s new draft guidance document comes after ...

The Food and Drug Administration (FDA) published new draft guidelines aimed at improving the accuracy and performance of pulse oximeters by considering the range of skin tones. The guidance, Pulse ...

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 Food and Drug Administration on Monday bolstered its recommendations for pulse oximeter testing following public uproar over how inaccurate readings led to different medical care for patients of ...

The U.S. Food and Drug Administration is seeking public comment on new recommendations for nonclinical and clinical performance testing to support premarket submissions for pulse oximeters for medical ...