Years of research have showed that pulse oximeters yield less accurate readings for people with darker skin tones, and now ...
The FDA announced its draft guidance on recommendations for studies assessing pulse oximeters to ensure the devices perform ...
Pulse oximeters help doctors evaluate a person's pulse rate and the oxygen saturation of your blood. The FDA is proposing ...
Manufacturers increasingly but still infrequently follow FDA guidance that recommends testing pulse oximeters on participants ...
New draft guidelines would increase the number of people with darker skin who should be included in clinical trials of the ...
Darker skin tones are typically the result of the presence of more of the pigment melanin, which can interfere with the absorption of light from the pulse oximeter. In practical terms, this means that ...
Rather than relying on those testing the devices to judge skin tones, the draft guidance suggests manufacturers should use ...
The Food and Drug Administration on Monday proposed a long-awaited plan aimed at improving how pulse oximeters work on people ...
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 ...
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Masimo Corp. and Apple Inc. have filed dueling post-trial briefs in a California federal court, following a retrial over ...