FDA, Pulse oximetry

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 patients of color
FDA issues draft guidance to improve accuracy of pulse oximeters for people with darker skin tones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 devices more reliable and less biased.
FDA calling on pulse oximeter makers to make life-saving changes to devices
Pulse oximeters help doctors evaluate a person's pulse rate and the oxygen saturation of your blood. The FDA is proposing changes to make them more accurate.
Pulse oximeters may misread oxygen levels in people of color
Federal health officials are proposing changes to make sure medical devices that measure oxygen levels are working for patients of color
FDA Calls for Better Accuracy of Pulse Oximeters in People of Color
Pulse oximeters -- those tiny devices that measure blood oxygen levels with a quick clip to your finger -- may soon get a major upgrade to ensure they work just as well for people of all skin tones. The U.
New FDA guidance aims to improve accuracy of pulse oximeters for people of color
A Food and Drug Administration (FDA) draft guidance would require manufacturers of pulse oximeters to gather far more clinical data to show the devices accurately work across a range of skin tones.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 long-awaited guidance released Monday comes in response to mounting evidence that the devices,
New FDA rules to cut racial bias in some, but not all, devices to measure oxygen in the blood
At a CVS store in a racially diverse neighborhood in Brooklyn Center, the only devices available to shoppers to measure their ...
FDA recommends fixing racial disparities in pulse oximeter readings
The Food and Drug Administration on Monday proposed a long-awaited plan aimed at improving how pulse oximeters work on people ...
Healthcare Dive4d
FDA issues much-anticipated guidance on pulse oximeters
director of the FDA’s Center for Devices and Radiological Health, said in a statement. The FDA first warned about problems with pulse oximeter accuracy in 2021. CDRH had listed draft guidance on ...
Star Tribune4d
FDA recommends more robust testing of pulse oximeters to avoid bias in people with dark skin tone
He said health and wellness pulse oximeters need ... Previously, Medtronic hired third-party firms to carry out pulse oximeter testing, an executive recently told the Minnesota Star Tribune.