Pulse oximeters overestimate O2 saturations in darker-skin patients; FDA acts (kind of)

But will the new guidance have any greater impact than last time?

Pulse oximeters for healthcare and consumer use are calibrated on patients with lighter skin. Manufacturers have recognized the devices’ suboptimal performance in darker-skinned patients for decades, but they have faced no serious regulatory or legal pressure to act.

In 2013, FDA issued a suggestion that manufacturers test devices on patients “with a ran…