The new research analyzed paperwork submitted for FDA approval to market a device for 767 oximeters that had been ... documents submitted before the FDA made its suggestion to diversify skin ...
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The FDA announced its draft guidance on recommendations for studies assessing pulse oximeters to ensure the devices perform ...
On November 1, 2023, a contingent of 25 US state attorneys ... general made special note of the fact that their letter was being dispatched on the one-year anniversary of an FDA-convened public ...
These devices, crucial for measuring blood oxygen levels, have shown discrepancies in accuracy when used on darker skin, leading to potential health risks for non-white patients, the study states ...
If you use a pulse oximeter for health monitoring, know that the FDA is working to improve their accuracy for all skin tones, ...