Years of research have showed that pulse oximeters yield less accurate readings for people with darker skin tones, and now ...
The U.S. health regulator on Monday proposed new guidelines for widely-used blood oxygen monitoring devices to improve their ...
The FDA recommendations apply to only professional oximeters used in hospitals, doctor's offices, and other medical settings.
The FDA's draft recommendations for pulse oximeters aims to include clinical studies involving at least 150 participants with ...
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Rather than relying on those testing the devices to judge skin tones, the draft guidance suggests manufacturers should use ...
In the fiercely competitive world of flagship smartphones, night photography and videography capabilities have become a ...
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 ...
A Food and Drug Administration (FDA) draft guidance would require manufacturers of pulse oximeters to gather far more ...
The FDA's recommendations, which aim to tighten regulatory oversight, include clinical studies involving at least 150 participants with diverse skin tones, ensuring that at least 25 percent of ...