On May 6, 2024, Masimo announced it received FDA approval of Stork, its baby monitoring system that provides parents and caregivers visual and audible alarms if an infant’s pulse rate (PR) and oxygen saturation (SpO2) readings fall outside of preset ranges.
About Masimo Stork
The Masimo Stork is an infant PR and SpO2 monitor for over-the-counter use. The device is worn on the infant’s foot. It communicates with a mobile application to display vital signs for review. It contains alarms to notify a caregiver if the infant’s vital signs go outside preset thresholds.
The device uses photoplethysmography to measure PR and SpO2 in infants. It’s indicated for the spot-checking and continuous monitoring of physiological parameters in infants aged 0 to 18 months who weigh between six to 30 pounds. The device is also indicated for continuous skin temperature measurements.
The Masimo Stork can be used with a boot that aids in the placement of securement of the device on the infant’s foot, an alarm and connectivity hub that communicates data from the device to a software app, a mobile app and cloud software.
The patented sensor technology is nested within the Stork boot, which is made from medical-grade silicone that conforms to the baby’s skin. The hub connects the Stork vital signs sensor/boot to the app, allowing parents to monitor their infant at home.
According to the device’s FDA approval letter, the baby monitoring system “can be used to supplement a caregiver’s decision to seek additional guidance for the care of an infant or neonate.” It’s not intended to alert caregivers of every episode of elevated or depressed PR or low SpO2, nor is it intended to replace traditional diagnosis or treatment by a health care professional.
The device was previously cleared for prescription use.
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