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 ...
The FDA announced its draft guidance on recommendations for studies assessing pulse oximeters to ensure the devices perform ...
Manufacturers increasingly but still infrequently follow FDA guidance that recommends testing pulse oximeters on participants ...
Acknowledging the disparity in pulse oximetry implicates a $2 billion industry that has faced stricter regulations in recent ...
Pulse oximeters help doctors evaluate a person's pulse rate and the oxygen saturation of your blood. The FDA is proposing ...
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Rather than relying on those testing the devices to judge skin tones, the draft guidance suggests manufacturers should use ...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 ...
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Masimo Corp. and Apple Inc. have filed dueling post-trial briefs in a California federal court, following a retrial over ...
That disparity caused an outcry during the early days of the COVID pandemic because pulse oximetry data helped determine who received care, including hospitalization. The new guidance recommends ...