Masimo touted significantly improved performance specifications for the RD SET sensors with Masimo Measure-through Motion and Low Perfusion SET pulse oximetry. The improved specs were already available for babies under 3 kg, so the new clearance makes them available to all newborns in the United States.
Research studies have shown that SET reduces severe retinopathy among premature babies and improves congenital heart disease screening in newborns, according to Masimo.
“Even though no one has been able to create pulse oximetry that outperforms SET, we have not allowed that to stop us from continuing our pursuit of perfecting pulse oximetry,” Masimo founder and CEO Joe Kiani said in a news release.