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The FDA announced its draft guidance on recommendations for studies assessing pulse oximeters to ensure the devices perform ...

The FDA noted that the new draft guidance applies to pulse oximeters that are intended for medical purposes, which are primarily used in hospital settings and doctor’s offices, and not for ...

Draft recommendations from the FDA call for larger, more inclusive studies to ensure pulse oximeters work for people with ...

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

Medtronic hired third-party firms to carry out pulse oximeter testing, an executive recently told the Minnesota Star Tribune. Medtronic said it has been conducting a clinical study using the Monk ...

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 It’s these device manufacturers that the agency is targeting with its draft guidance.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.