The Englewood, Colorado–based company said its submission marks a milestone in the evolution of pulse oximetry. Its laser technology enables the accurate measurement of oxygen levels in patients with dark skin.

Pulse oximetry received heightened attention a few years ago as a method to detect metrics that may indicate COVID-19 infection. As notoriety increased, so did scrutiny, as the FDA and pulse oximeter makers were called on to ensure that the devices delivered consistent, accurate readings across different skin pigmentations after studies highlighted a lack of accuracy with darker skin. The FDA this year issued recommendations urging device makers to address the issue in both new and existing technologies.