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

The regulator said the guidance, if finalized, would apply to oxygen monitoring devices known as pulse oximeters that are used for medical purposes. Pilot project monitors patients while they ...

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.

Pulse Oximeters May Misread Oxygen Levels in People of Color ... leading to multiple meetings and studies by FDA regulators since 2022. The FDA’s draft recommendations, which are not binding ...