Healio3d
FDA releases draft guidance on pulse oximeter study recommendations
The FDA announced its draft guidance on recommendations for studies assessing pulse oximeters to ensure the devices perform ...
WMDT1d
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.
technologynetworks4d
Pulse Oximeters Rarely Tested On Diverse Subjects
Manufacturers increasingly but still infrequently follow Food and Drug Administration (FDA) guidance that recommends testing pulse oximeters on participants with a range of skin pigmentations, ...
WPTZ Plattsburgh-Burlington on MSN6d
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 ...
Atlanta Journal-Constitution1d
Pulse oximeters may misread oxygen levels in people of color
The Food and Drug Administration’s recommendations apply to pulse oximeters, which are clip-on devices used in hospitals and medical clinics to ensure patients are getting enough oxygen.
Star Tribune4d
New FDA rules to cut racial bias in some, but not all, devices to measure oxygen in the blood
The Nonin TruO2 OTC photographed as it would be used at Nonin Medical Inc. in Plymouth in December 2024. (Ayrton Breckenridge/The Minnesota Star Tribune) ...
EMS16d
Study: Only 25% of pulse oximeters tested for skin-tone bias post-FDA guidance
A new study by the Johns Hopkins Bloomberg School of Public Health highlights a slow progression in the diversity of testing for pulse oximeters, despite FDA recommendations. These devices ...