Healio3 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FDA releases draft guidance on pulse oximeter study recommendations
The FDA announced its draft guidance on recommendations for studies assessing pulse oximeters to ensure the devices perform ...
The American Journal of Managed Care10 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 ...
Medpage Today on MSN17 天
Diversity Reporting Improved in Pulse Oximetry Testing After FDA Guidance
There was "low but improving uptake" of reporting about the diversity of participants in summary documents for FDA-cleared ...
Healio6 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 ...
Scripps News on MSN9 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 ...
FDA issues draft guidance to improve accuracy of pulse oximeters for people with darker ...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 ...
IFLScience9 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 ...
FDA recommends more robust testing of pulse oximeters to avoid bias in people with dark ...
New draft guidelines would increase the number of people with darker skin who should be included in clinical trials of the ...
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 ...
FierceBiotech10 天
FDA issues draft guidance on ensuring pulse oximeter accuracy across skin tones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 ...