The FDA announced its draft guidance on recommendations for studies assessing pulse oximeters to ensure the devices perform ...
Years of research have showed that pulse oximeters yield less accurate readings for people with darker skin tones, and now ...
Manufacturers increasingly but still infrequently follow FDA guidance that recommends testing pulse oximeters on participants ...
The Food and Drug Administration on Monday bolstered its recommendations for pulse oximeter testing following public uproar ...
Federal health officials are proposing changes to make sure medical devices that measure oxygen levels are working for ...
Rather than relying on those testing the devices to judge skin tones, the draft guidance suggests manufacturers should use ...
Manufacturers increasingly but still infrequently follow Food and Drug Administration guidance that recommends testing pulse oximeters on participants with a range of skin pigmentations, according to ...
These devices, crucial for measuring blood oxygen levels, have shown discrepancies in accuracy when used on darker skin, leading to potential health risks for non-white patients, the study states ...
The Food and Drug Administration on Monday proposed a long-awaited plan aimed at improving how pulse oximeters work on people ...
A Food and Drug Administration (FDA) draft guidance would require manufacturers of pulse oximeters to gather far more ...
The Food and Drug Administration on Monday released much-anticipated testing recommendations for pulse oximeters. The draft ...
Pulse Oximeters May Misread Oxygen Levels in People of Color. the FDA Wants to Change That WASHINGTON (AP) — Makers of medical devices that quickly measure oxygen levels in the blood would have ...