Years of research have showed that pulse oximeters yield less accurate readings for people with darker skin tones, and now ...
Federal health officials are proposing changes to make sure medical devices that measure oxygen levels are working for ...
At a CVS store in a racially diverse neighborhood in Brooklyn Center, the only devices available to shoppers to measure their ...
Following the FDA’s release of a guidance requesting more diversity in pulse oximeter testing, the number of clearance ...
New draft guidelines would increase the number of people with darker skin who should be included in clinical trials of the ...
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 ...
Rather than relying on those testing the devices to judge skin tones, the draft guidance suggests manufacturers should use ...
A Food and Drug Administration (FDA) draft guidance would require manufacturers of pulse oximeters to gather far more ...
The Food and Drug Administration on Monday proposed a long-awaited plan aimed at improving how pulse oximeters work on people ...
Manufacturers increasingly but still infrequently follow Food and Drug Administration guidance that recommends testing pulse oximeters on participants with a range of skin pigmentations, according to ...
The agency is proposing that device manufacturers improve their testing to including larger, more diverse sample sizes.
Pulse oximeters help doctors evaluate a person's pulse rate and the oxygen saturation of your blood. The FDA is proposing ...