The common medical devices don’t work as well for Black patients. The FDA is now trying to do something about it.

A Food and Drug Administration (FDA) draft guidance would require manufacturers of pulse oximeters to gather far more clinical data to show the devices accurately work across a range of skin tones.

The FDA announced its draft guidance on recommendations for studies assessing pulse oximeters to ensure the devices perform ...

The FDA announced Monday that it has published draft guidance for manufacturers of pulse oximeters that offers recommendations for the clinical testing and labeling of these electronic medical ...

On January 7, 2025, the FDA released the long-awaited draft guidance on “Pulse Oximeters for Medical Purposes—Non-Clinical and Clinical Performance Testing, Labeling, and Premarket Submission ...

Manufacturers increasingly but still infrequently follow FDA guidance that recommends testing pulse oximeters on participants ...

Previously, Medtronic hired third-party firms to carry out pulse oximeter testing, an executive recently told the Minnesota Star Tribune. Medtronic said it has been conducting a clinical study ...

Individuals with darker skin tones may have difficulty using certain medical equipment according to recent studies.

The Food and Drug Administration’s recommendations apply to pulse oximeters, which are clip ... least 150 patients of different skin tones in clinical studies Including at least 25% of patients ...

"Clinical data have demonstrated that many hospital pulse oximeters routinely read falsely higher in individuals with darker skin color than in those with lighter skin color -- that is, they ...

Federal health officials are proposing changes to make sure medical devices that measure oxygen levels are working for patients of color ...