Masimo announced FDA clearance of Stork?, a baby monitoring system that provides alarms to parents or other caregivers, for use with healthy babies 0-18 months of age, without the need for a prescription. The over-the-counter (OTC) version of Stork utilizes the same Masimo pulse oximetry technology that monitors more than 10 million babies in hospitals every year and is used at 9 of the top 10 U.S. hospitals. The FDA-cleared OTC version of Masimo Stork monitors a baby?s key vitals data including oxygen saturation level (SpO2), pulse rate (PR), and skin temperature; crucially, Stork notifies caregivers with visual and audible alarms if a baby?s SpO2 or PR readings fall outside of preset ranges.

Stork leverages the same pulse oximetry technology that has been used on babies in the neonatal intensive care unit (NICU) for decades, helping to improve health outcomes for the youngest and most vulnerable patients. Known as Signal Extraction Technology, or SET, this technology has helped clinicians reduce the incidence of neonatal blindness from retinopathy of prematurity and has led to significant improvements in screening newborns for critical congenital heart disease.