Masimo Receives FDA Clearance for Stork Over-the-Counter (OTC) Baby Monitoring System

Masimo (NASDAQ: MASI), a global leader in innovative monitoring technologies currently celebrating its 35^th anniversary, 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.

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Masimo Stork (Photo: Business Wire)

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 year¹ and is used at 9 of the top 10 U.S. hospitals.² 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 prematurity³ and has led to significant improvements in screening newborns for critical congenital heart disease.⁴

“Bringing your new baby home from the hospital is exciting, but can be nerve- wracking—and it’s something I remember vividly from when my son was born and required at-home monitoring,” said Joe Kiani, Founder and CEO of Masimo. “I believe that by empowering parents and caregivers with the same Masimo pulse oximetry technology that hospitals have been using on babies for decades, we can help them feel more informed and confident when caring for their baby. It is particularly fitting that we received this clearance and are making this announcement as we celebrate the 35^th anniversary of the company I founded with a mission to improve lives everywhere, especially those of the youngest and most fragile among us. Thirty-five years ago I envisioned Stork. I am so proud of our team for Stork – it is a culmination of science and design at its best.”