Problems with pulse oximeters have been known for decades, but it wasn’t until the pandemic that the real dangers to Black ...

The FDA announced its draft guidance on recommendations for studies assessing pulse oximeters to ensure the devices perform ...

Pulse oximeter apple on sale watch series 5, U.S. judge rules Apple Watch infringed Masimo s pulse oximeter on sale ...

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

The FDA noted that the new draft guidance applies to pulse oximeters that are intended for medical purposes, which are primarily used in hospital settings and doctor’s offices, and not for ...

The above notwithstanding, it was not until March 4, 2013, that the FDA issued the final version of its guidance for industry and FDA staff for prescription-use-only class II pulse oximeters.

Pulse oximeters specifically intended for medical use do fall under FDA purview. It’s these device manufacturers that the agency is targeting with its draft guidance. The gold standard and most ...

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.

But her request for supplemental oxygen while hospitalized was denied, Starr said, because readings from a pulse oximeter on her finger falsely indicated that she was getting plenty of air on her own.