TCTMD6d
FDA Issues Draft Guidance for Improving Skin Tone Disparities of Pulse Oximeters
The agency is proposing that device manufacturers improve their testing to including larger, more diverse sample sizes.
EurekAlert!6d
Pulse oximeters infrequently tested by manufacturers on diverse sets of subjects
Manufacturers increasingly but still infrequently follow Food and Drug Administration guidance that recommends testing pulse oximeters on participants with a range of skin pigmentations ...
Marin Independent Journal6d
Pulse oximeters may misread oxygen levels in people of color. The FDA wants to change that
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.
Healio5d
Diversity in pulse oximeter clearance summaries increases after 2013 FDA guidance
Following the FDA’s release of a guidance requesting more diversity in pulse oximeter testing, the number of clearance summary documents discussing race and ethnicity/skin tone rose, according ...
Star Tribune6d
New FDA rules to cut racial bias in some, but not all, devices to measure oxygen in the blood
The Nonin TruO2 OTC photographed as it would be used at Nonin Medical Inc. in Plymouth in December 2024. (Ayrton Breckenridge/The Minnesota Star Tribune) ...