Years of research have showed that pulse oximeters yield less accurate readings for people with darker skin tones, and now ...
Pulse oximeters help doctors evaluate a person's pulse rate and the oxygen saturation of your blood. The FDA is proposing ...
New draft guidelines would increase the number of people with darker skin who should be included in clinical trials of the ...
Manufacturers increasingly but still infrequently follow FDA guidance that recommends testing pulse oximeters on participants ...
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 ...
The FDA has published a set of long-awaited recommendations to the industry to help ensure that pulse oximeters work correctly across all skin tones. | The FDA has published a set of long-awaited ...
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 ...
Masimo Corp. and Apple Inc. have filed dueling post-trial briefs in a California federal court, following a retrial over ...
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The draft guidance will be open for comment for 60 days. Pulse oximetry is a non-invasive way of measuring blood oxygen ...