The FDA announced its draft guidance on recommendations for studies assessing pulse oximeters to ensure the devices perform ...

Individuals with darker skin tones may have difficulty using certain medical equipment according to recent studies.

Manufacturers increasingly but still infrequently follow FDA guidance that recommends testing pulse oximeters on participants ...

Makers of medical devices that quickly measure oxygen levels in the blood would have to gather extra data to show that their ...

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

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.

The Nonin TruO2 OTC photographed as it would be used at Nonin Medical Inc. in Plymouth in December 2024. (Ayrton Breckenridge/The Minnesota Star Tribune) ...

These devices, crucial for measuring blood oxygen levels, have shown discrepancies in accuracy when used on darker skin, ...

At a CVS store in a racially diverse neighborhood in Brooklyn Center, the only devices available to shoppers to measure their ...

Manufacturers increasingly but still infrequently follow Food and Drug Administration guidance that recommends testing pulse oximeters on participants with a range of skin pigmentations, according to ...