The common medical devices don’t work as well for Black patients. The FDA is now trying to do something about it.
Manufacturers increasingly but still infrequently follow FDA guidance that recommends testing pulse oximeters on participants with a range of skin pigmentations, according to a new study.
The agency outlined what information it would like to see in premarket submissions for medical pulse oximeters, including validation of the devices’ accuracy and ensuring the devices are tested ...
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 ...
A Food and Drug Administration (FDA) draft guidance would require manufacturers of pulse oximeters to gather far ... s blood oxygen levels, are less accurate on people with darker skin.
SKOKIE, Ill., Jan. 28, 2025 /PRNewswire/ -- A fingertip pulse oximeter distributed by Concord health Supply, Inc. , a family-owned business in Skokie, is earning praise as the best in class for home ...
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.
and uses an oxygen tank at home. But her request for supplemental oxygen while hospitalized was denied, Starr said, because readings from a pulse oximeter on her finger falsely indicated that she ...
The FDA held two advisory panel meetings — in 2022 and 2024 — to discuss the accuracy of pulse oximeters and ways to improve and evaluate their performance, and the agency issued a safety ...