The Food and Drug Administration on Monday bolstered its recommendations for pulse oximeter testing following public uproar ...
Years of research have showed that pulse oximeters yield less accurate readings for people with darker skin tones, and now ...
Manufacturers increasingly but still infrequently follow FDA guidance that recommends testing pulse oximeters on participants ...
Pulse oximeters help doctors evaluate a person's pulse rate and the oxygen saturation of your blood. The FDA is proposing ...
Acknowledging the disparity in pulse oximetry implicates a $2 billion industry that has faced stricter regulations in recent ...
The FDA announced its draft guidance on recommendations for studies assessing pulse oximeters to ensure the devices perform ...
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Rather than relying on those testing the devices to judge skin tones, the draft guidance suggests manufacturers should use ...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 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 ...
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Masimo Corp. and Apple Inc. have filed dueling post-trial briefs in a California federal court, following a retrial over ...