The Food and Drug Administration on Monday bolstered its recommendations for pulse oximeter testing following public uproar ...
The U.S. health regulator on Monday proposed new guidelines 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Rather than relying on those testing the devices to judge skin tones, the draft guidance suggests manufacturers should use ...
Years of research have showed that pulse oximeters yield less accurate readings for people with darker skin tones, and now ...
The agency is proposing that device manufacturers improve their testing to including larger, more diverse sample sizes.
The FDA released the guidance in response to concerns that the devices are less accurate in people with darker skin ...
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 ...
Today, the U.S. Food and Drug Administration published new draft guidance aimed at helping improve the accuracy and performance of pulse oximeters – important devices for patient care that are used to ...