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 ...
FDA issues draft guidance to improve accuracy of pulse oximeters for people with darker skin tones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 ...
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 ...
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 ...
STAT5d
FDA releases long-awaited guidance to improve accuracy of pulse oximeters for all skin tones
Rather than relying on those testing the devices to judge skin tones, the draft guidance suggests manufacturers should use ...
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 ...
usaherald2h
Masimo and Apple File Post-Trial Briefs in Apple Watch IP Dispute
Masimo Corp. and Apple Inc. have filed dueling post-trial briefs in a California federal court, following a retrial over ...
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 MSN13d
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 ...