EMS117h
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 ...
Healio20h
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 ...
New FDA rules to reduce racial bias in some common devices measuring oxygen in blood
At a CVS store in a racially diverse neighborhood in Brooklyn Center, the only devices available to shoppers to measure their ...
TCTMD2d
FDA Issues Draft Guidance for Improving Skin Tone Disparities of Pulse Oximeters
The agency is proposing that device manufacturers improve their testing to including larger, more diverse sample sizes.
WYFF3d
Pulse oximeters may misread oxygen levels in people of color. The FDA wants to change that
Makers of medical devices that quickly measure oxygen levels in the blood would have to gather extra data to show that their ...
scrippsnews3d
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 ...
healthday3d
FDA Calls for Better Accuracy of Pulse Oximeters in People of Color
Pulse oximeters -- those tiny devices that measure blood oxygen levels with a quick clip to your finger -- may soon ge ...
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 over how inaccurate readings led to different medical care for patients of ...