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

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

The FDA announced its draft guidance on recommendations for studies assessing pulse oximeters to ensure the devices perform ...

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 ...

The agency is proposing that device manufacturers improve their testing to including larger, more diverse sample sizes.

These devices, crucial for measuring blood oxygen levels, have shown discrepancies in accuracy when used on darker skin, leading to potential health risks for non-white patients, the study states ...

Pulse oximeters helped drive racial inequities in care during the pandemic, but many devices at drugstores and online won’t ...

The Food and Drug Administration on Monday released much-anticipated testing recommendations for pulse oximeters. The draft guidance follows years of discussion about concerns that the devices can ...

Pulse oximeters -- those tiny devices that measure blood oxygen levels with a quick clip to your finger -- may soon get a ...

Following the FDA’s release of a guidance requesting more diversity in pulse oximeter testing, the number of clearance ...

The U.S. Food and Drug Administration released draft guidelines on Jan. 6 proposing that manufacturers conduct larger, more ...

The US Food and Drug Administration (FDA) has published draft guidance aimed at improving the performance of pulse oximeters across all skin colours, following research suggesting the medical devices ...