STAT29d
Fixing pulse oximeters requires federal might and possible legal action, researchers say
The new research analyzed paperwork submitted for FDA approval to market a device for 767 oximeters that had been ... documents submitted before the FDA made its suggestion to diversify skin ...
CNN22d
FDA issues draft guidance to improve accuracy of pulse oximeters for people with darker skin tones
Years of research have showed that pulse oximeters yield less accurate readings for people with darker skin tones, and now the US Food and Drug ... with dark skin. The FDA announced Monday that ...
technologynetworks15d
Pulse Oximeters Rarely Tested On Diverse Subjects
The FDA made the recommendation in 2013 ... medical devices that are sufficiently similar to devices that have already been approved by the FDA. Pulse oximeters intended for use in medical ...
The Independent22d
Pulse oximeters may misread oxygen levels in people of color. The FDA wants to change that
At such a critical moment in US history ... But the FDA makes clear it expects to see new diversity data from manufacturers requesting approval for changes or updates to older oximeters.
Times Union22d
Pulse oximeters may misread oxygen levels in people of color. The FDA wants to change that
But the FDA makes clear it expects to see new diversity data from manufacturers requesting approval for changes or updates to older oximeters ... would answer? Let us know and we may be able ...