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 ...
The U.S. health regulator on Monday proposed a new guidance for widely used blood oxygen monitoring devices to improve their ...
Rather than relying on those testing the devices to judge skin tones, the draft guidance suggests manufacturers should use ...
The agency is proposing that device manufacturers improve their testing to including larger, more diverse sample sizes.
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 ...
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 ...
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The U.S. Food and Drug Administration proposed new guidance for devices used to monitor blood oxygen levels to improve their ...