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Pulse oximeters infrequently tested by manufacturers on diverse sets of subjects
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 ...
Armed robbery in Revesby5h
Pulse Oximeters Rarely Tested on Diverse Subjects
Manufacturers increasingly but still infrequently follow Food and Drug Administration guidance that recommends testing pulse oximeters on participants ...
New FDA rules to cut racial bias in some, but not all, devices to measure oxygen in the blood
At a CVS store in a racially diverse neighborhood in Brooklyn Center, the only devices available to shoppers to measure their ...
HME News11h
FDA issues draft guidance on pulse oximeters
The U.S. Food and Drug Administration on Jan. 6 issued new draft guidance to help improve the accuracy and performance of pulse oximeters that are used for medical purposes across populations with a r ...
Pulse oximeters may misread oxygen levels in people of color. The FDA wants to change that
Federal health officials are proposing changes to make sure medical devices that measure oxygen levels are working for ...
JD Supra6h
FDA Publishes a Wide Range of Guidances in the Final Days of the Biden Administration
On January 6 and 7, 2025, the FDA announced, by our count, 31 draft or final guidances, on a wide range of topics. Historically, an ...