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 ...
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 ...
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 ...
On November 1, 2023, a contingent of 25 US state attorneys ... general made special note of the fact that their letter was being dispatched on the one-year anniversary of an FDA-convened public ...
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 Administration is proposing ...
The US health regulator on Monday proposed new guidelines for widely-used blood oxygen monitoring devices to improve their performance across skin tones amid growing evidence that the current ones ...