FDA, skin tone
FDA seeks to boost accuracy of blood-oxygen monitors across skin tones
The U.S. health regulator on Monday proposed new guidelines for widely-used blood oxygen monitoring devices to improve their performance across skin tones amid growing evidence that the current ones are not reliable for patients with darker skin.
FDA releases long-awaited guidance to improve accuracy of pulse oximeters for all skin tones
Rather than relying on those testing the devices to judge skin tones, the draft guidance suggests manufacturers should either use the newly developed Monk Skin Tone scale or another scale, called the individual typology angle (ITA), which is based on spectrophotometric measurements.
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The U.S. health regulator on Monday proposed a new guidance for widely used blood oxygen monitoring devices to improve their ...
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