In 2013, the FDA issued premarket guidance for developers of pulse oximeters in which it recommended that they have “a range of skin pigmentation” represented in their clinical testing of the ...

A Food and Drug Administration (FDA) draft guidance would require manufacturers of pulse oximeters to gather far more clinical data to show the devices accurately work across a range of skin tones.

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

The Food and Drug Administration on Monday proposed a long-awaited plan aimed at improving how pulse oximeters work on people with darker skin — an effort that comes years after research showing ...

Oximeters have become an essential household device to keep your blood oxygen levels (SpO2) in check. Dipping SpO2 levels is one of the key indicators of the COVID-19 infection in people.

to discuss improving pulse oximeter performance. It also noted that the FDA was considering the “utility of a clinical trial design that includes the entire range of skin pigmentation and also ...

The Food and Drug Administration on Monday bolstered its recommendations for pulse oximeter testing following ... the devices in patients with wider ranges of skin tones, including from three ...