FDA clears new OTC baby monitoring system

The US Food and Drug Administration (FDA) has cleared Stork new baby monitoring system intended for use with healthy babies 0 to 18 months of age. This is an over-the-counter (OTC) system which is indicated for spot-checking and continuous monitoring of oxygen saturation level (SpO2) and pulse rate (PR) during no motion, motion, and low perfusion conditions in infants and neonates 0 to 18 months of age weighing 6 to 30 lbs.

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. 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.

“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.”

Stork bundles are currently available at major and specialty retailers nationwide and at masimo.com as a non-medical device for general health and wellness purposes. Alongside the FDA clearance, Masimo will make Stork’s new alarm features available to all existing and new Stork users through the Masimo Stork App, in an update scheduled to be released this summer. FDA-cleared OTC Stork bundles will be available for purchase online and at retailers this summer.

Masimo’s patented SET® sensor technology nests within the Stork boot, which is made from an ultra-soft, medical-grade silicone that conforms gently to the baby’s skin and is available in three sizes to ensure a perfect fit as the child grows. The sensor embedded in the boot is the product of meticulous engineering that harnesses decades of expertise in noninvasive monitoring to detect babies’ SpO2, PR, and skin temperature continuously, with unprecedented accuracy and dependability.

Masimo Stork has a sleek, minimalist design that fits seamlessly into any nursery and on the baby’s foot. 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 are designed to leverage and be compatible with future edge AI-based features, which are in development. The first application of the edge AI technology will be identifying babies who have turned face down. For those who do not require streaming video, or detection via video of babies being face down, the Stork Vitals bundle replaces the camera with a hub, which connects the Stork vital signs sensor/boot to the Stork app, while still allowing parents to 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 intended for the monitoring of multiple physiological parameters. Masimo Stork is 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 6 and 30 lbs. Masimo Stork OTC is also indicated for continuous skin temperature measurements of infants and neonates who are 0 to 18 months of age and between 6 and 30 lbs. Masimo Stork is indicated for use in home environments.

Masimo 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.

Masimo Stork is not intended to replace the monitoring, diagnosis, or treatment provided by a physician or healthcare provider. Masimo Stork is not intended for use with infants and neonates previously diagnosed with cardiovascular or respiratory disease or conditions.