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FDA issues draft guidance to improve accuracy of pulse oximeters for people with darker skin tones
But many studies have revealed that pulse oximeters can measure blood oxygen levels as higher than they actually are for people with dark skin. The FDA announced Monday that it has published draft ...
The problem with pulse oximeters your doctor probably doesn’t know.
The common medical devices don’t work as well for Black patients. The FDA is now trying to do something about it.
Healio11d
FDA releases draft guidance on pulse oximeter study recommendations
The FDA announced its draft guidance on recommendations for studies assessing pulse oximeters to ensure the devices perform ...
Healthcare Dive19d
FDA issues much-anticipated guidance on pulse oximeters
The FDA first warned about problems with pulse oximeter accuracy in 2021. CDRH had listed draft guidance on pulse oximeters among its priorities for the 2024 fiscal year but missed the cutoff.
technologynetworks12d
Pulse Oximeters Rarely Tested On Diverse Subjects
Manufacturers increasingly but still infrequently follow FDA guidance that recommends testing pulse oximeters on participants ...
Health Affairs11d
The Overdue Imperative Of Cross-Racial Pulse Oximeters
The FDA’s involvement with non-invasive pulse oximetry dates to September 7, 1992, at which time a General Guidance document was issued for manufacturers of pulse oximeters. The above ...
CNN18d
FDA issues draft guidance to improve accuracy of pulse oximeters for people with darker skin tones
The FDA announced Monday that it has published draft guidance for manufacturers of pulse oximeters that offers recommendations for the clinical testing and labeling of these electronic medical ...