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The common medical devices don’t work as well for Black patients. The FDA is now trying to do something about it.
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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.
We used the nitrous oxide-body plethysmograph method to record the pulmonary capillary blood flow pulse and the phonocardiogram to determine the time of opening and closing of the pulmonary valve. The ...
The US Food and Drug Administration (FDA) has published draft guidance aimed at improving the performance of pulse oximeters across all skin colours, following research suggesting the medical devices ...
The U.S. Food and Drug Administration on Jan. 6 issued new draft guidance to help improve the accuracy and performance of pulse oximeters that are used for medical purposes across populations with a r ...
Manufacturers increasingly but still infrequently follow Food and Drug Administration guidance that recommends testing pulse oximeters on participants with a range of skin pigmentations, according to ...
FDA Calls for Better Accuracy of Pulse Oximeters in People of Color By India Edwards HealthDay Reporter TUESDAY, Jan. 7, 2025 (HealthDay News) -- Pulse oximeters -- those tiny devices that measure ...
In 2013, the FDA issued premarket guidance for developers of pulse oximeters in which it recommended that they have “a range of skin pigmentation” represented in their clinical testing of the ...
Clinical studies must now include 25% of patients with darker skin tone Over-the-counter oximeters are not covered under the new guidelines TUESDAY, Jan. 7, 2025 (HealthDay News) -- Pulse ...