Healio2 天
FDA releases draft guidance on pulse oximeter study recommendations
The FDA announced its draft guidance on recommendations for studies assessing pulse oximeters to ensure the devices perform ...
FDA recommends more robust testing of pulse oximeters to avoid bias in people with dark ...
The Food and Drug Administration on Monday bolstered its recommendations for pulse oximeter testing following public uproar ...
The American Journal of Managed Care9 天
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 ...
FDA recommends fixing racial disparities in pulse oximeter readings
The Food and Drug Administration on Monday proposed a long-awaited plan aimed at improving how pulse oximeters work on people ...
FDA issues draft guidance to improve accuracy of pulse oximeters for people with darker ...
Years of research have showed that pulse oximeters yield less accurate readings for people with darker skin tones, and now ...
technologynetworks3 天
Pulse Oximeters Rarely Tested On Diverse Subjects
Manufacturers increasingly but still infrequently follow FDA guidance that recommends testing pulse oximeters on participants ...
WMDT13 小时
Research shows blood oximeters aren’t properly reading Patients of Color
Individuals with darker skin tones may have difficulty using certain medical equipment according to recent studies.
Scripps News on MSN8 天
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 ...
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 ...
IFLScience8 天
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 ...
Healio5 天
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 ...
Too Old to Operate3 天
Recommendations Aim for More Inclusive Pulse Oximeter Testing
Draft recommendations from the FDA call for larger, more inclusive studies to ensure pulse oximeters work for people with ...