FDA clears way for ped screening with new pulse oximeter indication

Masimo has received FDA 510(k) clearance for Masimo's Signal Extraction Technology (SET) pulse oximeters, rainbow SET Pulse CO-Oximeters and neonatal sensors with labeling for screening newborns for critical congenital heart disease (CCHD).

Masimo SET pulse oximeters and sensors have previously been cleared to measure oxygen saturation and pulse rate during motion and low perfusion conditions in newborns, but this is specific labeling indicating the use of pulse oximeters, in conjunction with a physical exam, to screen newborns for CCHD.

The FDA clearance comes as California recently became the latest state to mandate CCHD pulse oximetry screening, following the U.S. Department of Health and Human Service's September 2011 action to add pulse oximetry CCHD screening for newborns as part of the Recommended Uniform Screening Panel.

The Masimo pulse oximeters that were the subject of this 510(k) clearance are the Radical-7, Rad-57 and Rad-87 Pulse CO-Oximeters with Masimo rainbow SET, and the Rad-5, Rad-5v and Rad-8 Pulse Oximeters with Masimo SET.