The common medical devices don’t work as well for Black patients. The FDA is now trying to do something about it.
Despite the new focus on the problem, there are still gaps in understanding why pulse oximeters don’t work as well in ...
A Food and Drug Administration (FDA) draft guidance would require manufacturers of pulse oximeters to gather far more clinical data to show the devices accurately work across a range of skin tones.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 Food and Drug Administration on Monday proposed a long-awaited plan aimed at improving how pulse oximeters work on people with darker skin — an effort that comes years after research showing ...
What prompted the new plan – and why does it matter? However, there’s a problem with the way that pulse oximeters work: they’re affected by the presence of pigments in the skin. Darker skin ...
The FDA has published a set of long-awaited recommendations to the industry to help ensure pulse oximeters work correctly across all skin tones. The agency’s new draft guidance document comes ...
WASHINGTON — Makers of medical devices that quickly measure oxygen levels in the blood would have to gather extra data to show that their products work ... apply to pulse oximeters, which ...
The Food and Drug Administration on Monday bolstered its recommendations for pulse oximeter ... have said they were working on boosting clinical trial diversity and oximeter accuracy before ...
Is skin pigmentation the ultimate problem with pulse oximeters? Maybe, maybe not. “The question that everybody wants to know right now is: Which devices work equally well, regardless of skin ...
WASHINGTON (AP) — Makers of medical devices that quickly measure oxygen levels in the blood would have to gather extra data to show that their products work ... apply to pulse oximeters, which ...
But her request for supplemental oxygen while hospitalized was denied, Starr said, because readings from a pulse oximeter on her finger falsely ... which measure oxygen levels in the blood, may not ...