FDA issues draft guidance to improve accuracy of pulse oximeters for people with darker skin tones
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 ...
Healio13d
FDA releases draft guidance on pulse oximeter study recommendations
The FDA announced its draft guidance on recommendations for studies assessing pulse oximeters to ensure the devices perform ...
STAT27d
Fixing pulse oximeters requires federal might and possible legal action, researchers say
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 ...
Pulse oximeters may misread oxygen levels in people of color. The FDA wants to change that
Federal health officials are proposing changes to make sure medical devices that measure oxygen levels are working for ...
Health Affairs12d
The Overdue Imperative Of Cross-Racial Pulse Oximeters
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 ...
EMS116d
Study: Only 25% of pulse oximeters tested for skin-tone bias post-FDA guidance
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 ...