The FDA announced its draft guidance on recommendations for studies assessing pulse oximeters to ensure the devices perform ...

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 ...

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 ...

Acknowledging the disparity in pulse oximetry implicates a $2 billion industry that has faced stricter regulations in recent ...

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Rather than relying on those testing the devices to judge skin tones, the draft guidance suggests manufacturers should use ...

The draft guidance will be open for comment for 60 days. Pulse oximetry is a non-invasive way of measuring blood oxygen ...

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Masimo Corp. and Apple Inc. have filed dueling post-trial briefs in a California federal court, following a retrial over ...

The Food and Drug Administration on Monday proposed a long-awaited plan aimed at improving how pulse oximeters work on people ...