Masimo Stork OTC Smart Baby Monitor Wins FDA Nod

Masimo has received U.S. Food and Drug Administration (FDA) clearance for its Stork baby monitoring system for healthy babies 0-18 months old, without needing a prescription. Stork issues alarms to parents or caregivers .
 
Stork was FDA cleared for use with a prescription in December 2023.
 
The over-the counter (OTC) version of Stork uses the same Masimo pulse oximetry tech used to monitor over ten million babies in hospitals every year. It monitors a baby’s key vitals, including oxygen saturation level (SpO₂), pulse rate (PR), and skin temperature. Visual and audible alarms are sounded if SpO₂ or PR levels fall outside preset ranges.
 
Stork uses Signal Extraction Technology (SET), the same pulse oximetry tech used on babies in the NICU for decades. SET has helps reduce the occurrence of neonatal blindness from retinopathy of prematurity and has improved screening of newborns for critical congenital heart disease.
 
The SET technology lies in the Stork boot, which is composed of a soft, medical-grade silicone that conforms to the baby’s skin and is available in three sizes. The sensor embedded in the boot and harnesses decades of expertise in noninvasive monitoring, according to Masimo.
 
“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 35th 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.”
 
Masimo is also currently evaluating a separation of its consumer audio and consumer health products business, which the company announced in March 2024.

More about Stork smart infant monitoring

The Stork Vitals+ bundle includes the boot with sensor that monitors baby’s skin temperature, PR, and SpO₂, and a 2K Quad High-Definition (QHD) capable camera with technology supported by the TODA platform from Like Minded Labs. The camera hardware and software architecture leverage and are compatible with future edge AI-based features, which are in development.
 
The first application of the edge AI technology, according to the company, will be identifying babies who have turned face down. For those who don’t need streaming video, or detection via video of babies being face down, the Stork Vitals bundle replaces the camera with a hub, which connects the vital signs sensor/boot to the Stork app, while still letting parents hear their baby. Stork also monitors the baby’s room conditions (ambient temperature and humidity).
 
Masimo Stork is 510(k) cleared for OTC use as a wearable device for monitoring of multiple physiological parameters. It’s indicated for spot-checking and continuous monitoring of SpO₂ and PR during no motion, motion, and low perfusion conditions in infants and neonates who are 0 to 18 months of age and between six and 30 lbs. Stork OTC is also indicated for continuous skin temperature measurements of infants and neonates who are 0 to 18 months of age and between six and 30 lbs. It’s indicated for use in home environments.
 
Stork can be used to supplement a caregiver’s decision to seek additional guidance for the care of an infant or neonate. It is not intended to provide notifications for every episode of the unexpected occurrences of elevated or depressed PR or low SpO₂; rather, Masimo Stork is intended to provide a notification only when sufficient data are available for analysis.