Federal health officials are proposing changes to make sure medical devices that measure oxygen levels are working for ...
Years of research have showed that pulse oximeters yield less accurate readings for people with darker skin tones, and now ...
New draft guidelines would increase the number of people with darker skin who should be included in clinical trials of the ...
A Food and Drug Administration (FDA) draft guidance would require manufacturers of pulse oximeters to gather far more ...
The agency is proposing that device manufacturers improve their testing to including larger, more diverse sample sizes.
Rather than relying on those testing the devices to judge skin tones, the draft guidance suggests manufacturers should use ...
Pulse oximeters -- those tiny devices that measure blood oxygen levels with a quick clip to your finger -- may soon get a ...
The Food and Drug Administration on Monday released much-anticipated testing recommendations for pulse oximeters. The draft guidance follows years of discussion about concerns that the devices can ...
Federal health officials are proposing changes to make sure medical devices that measure oxygen levels are working for patients of color ...
The U.S. Food and Drug Administration on Jan. 6 issued new draft guidance to help improve the accuracy and performance of pulse oximeters that are used for medical purposes across populations with a r ...
The FDA released the guidance in response to concerns that the devices are less accurate in people with darker skin ...