The common medical devices don’t work as well for Black patients. The FDA is now trying to do something about it.
At a CVS store in a racially diverse neighborhood in Brooklyn Center, the only devices available to shoppers to measure their ...
The FDA announced its draft guidance on recommendations for studies assessing pulse oximeters to ensure the devices perform ...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 the US Food and Drug Administration is proposing guidance to help make ...
The FDA made the recommendation in 2013, following reports that pulse oximeters—devices that measure blood-oxygen levels by shining light through the skin—can be less accurate when used on people with ...
The FDA's recommendations apply to pulse oximeters ... doesn't regulate the vast majority of over-the-counter oximeters, most of which are considered "general wellness" devices by the agency.
Pulse oximeters measure the amount of light that ... Although the impact of (melanin-mediated) skin pigmentation on the accuracy of pulse oximetry readings has been under active investigation ...
The Food and Drug Administration’s recommendations apply to pulse oximeters ... t regulate the vast majority of over-the-counter oximeters, most of which are considered “general wellness ...
Pulse oximeters specifically intended for medical ... The gold standard and most accurate way of testing whether a person has normal oxygen levels is to stick a needle into a person’s wrist ...
But several studies have suggested that darker skin pigmentation can sometimes throw off the accuracy of readings ... majority of over-the-counter oximeters, most of which are considered "general ...
But her request for supplemental oxygen while hospitalized was denied, Starr said, because readings from a pulse oximeter on her finger falsely indicated that she was getting plenty of air on her own.