FDA recommends more robust testing of pulse oximeters to avoid bias in people with dark skin tone
The Food and Drug Administration on Monday bolstered its recommendations for pulse oximeter testing following public uproar ...
New FDA rules to cut racial bias in some, but not all, devices to measure oxygen in the blood
At a CVS store in a racially diverse neighborhood in Brooklyn Center, the only devices available to shoppers to measure their ...
FDA issues draft guidance to improve accuracy of pulse oximeters for people with darker skin tones
Years of research have showed that pulse oximeters yield less accurate readings for people with darker skin tones, and now ...
The American Journal of Managed Care6d
Racial and Ethnic Bias in Pulse Oximetry Is Failing Patients
Acknowledging the disparity in pulse oximetry implicates a $2 billion industry that has faced stricter regulations in recent ...
Scripps News on MSN5d
FDA calling on pulse oximeter makers to make life-saving changes to devices
Pulse oximeters help doctors evaluate a person's pulse rate and the oxygen saturation of your blood. The FDA is proposing ...
EMS12d
Study: Only 25% of pulse oximeters tested for skin-tone bias post-FDA guidance
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 ...
EurekAlert!2d
Pulse oximeters infrequently tested by manufacturers on diverse sets of subjects
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 ...
IFLScience5d
Decades-Old Problem Of Pulse Oximetry Across Skin Tones Targeted By New Draft FDA Guidance
Darker skin tones are typically the result of the presence of more of the pigment melanin, which can interfere with the absorption of light from the pulse oximeter. In practical terms, this means that ...
Healio2d
Diversity in pulse oximeter clearance summaries increases after 2013 FDA guidance
Following the FDA’s release of a guidance requesting more diversity in pulse oximeter testing, the number of clearance ...
MedPage Today on MSN12d
Diversity Reporting Improved in Pulse Oximetry Testing After FDA Guidance
"The most important finding is that although there were more mentions of skin color descriptors in performance testing after ...
FierceBiotech6d
FDA issues draft guidance on ensuring pulse oximeter accuracy across skin tones
The FDA has published a set of long-awaited recommendations to the industry to help ensure that pulse oximeters work correctly across all skin tones. | The FDA has published a set of long-awaited ...
FDA issues much-anticipated guidance on pulse oximeters
The FDA released the guidance in response to concerns that the devices are less accurate in people with darker skin ...