The common medical devices don’t work as well for Black patients. The FDA is now trying to do something about it.
A Food and Drug Administration (FDA) draft guidance would require manufacturers of pulse oximeters to gather far more clinical data to show the devices accurately work across a range of skin tones.
The FDA announced its draft guidance on recommendations for studies assessing pulse oximeters to ensure the devices perform ...
Manufacturers increasingly but still infrequently follow FDA guidance that recommends testing pulse oximeters on participants ...
Years of research have showed that pulse oximeters yield less accurate readings for people with darker skin tones, and now the US Food and Drug Administration is proposing guidance to help make ...
The Food and Drug Administration on Monday bolstered its recommendations for pulse oximeter testing following public uproar over how inaccurate readings led to different medical care for patients ...
Federal health officials are proposing changes to make sure medical devices that measure oxygen levels are working for ...
On November 1, 2023, a contingent of 25 US state attorneys general wrote to the commissioner of the Food and Drug Administration (FDA) to encourage the agency “to act with urgency to address the ...
Individuals with darker skin tones may have difficulty using certain medical equipment according to recent studies.
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The doctors and nurses didn’t believe Tomisa Starr was having trouble breathing. Two years ago, Starr, 61, of Sacramento, California, was in the hospital for a spike in her blood pressure.