The Masimo Stork baby monitoring system is offered as a non-medical device for general health and wellness purposes at retailers nationwide. Credit: Masimo / Business Wire.

Masimo has received the US Food and Drug Administration (FDA) clearance for its baby monitoring system, Stork.

The system is intended for prescription use with sick and healthy babies aged between zero and eight months. It can be used as a medical device for continuously monitoring these babies at home.

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Stork is offered as a non-medical device for general health and wellness purposes at retailers nationwide.

It leverages Masimo’s Signal Extraction Technology (SET), the same technology that monitors more than ten million babies in hospitals annually, to monitor a baby’s health continuously and precisely.

Upon prescription, parents and family members can now receive notifications about their baby’s pulse rate (PR), oxygen saturation (SpO₂), and skin temperature. They can remotely share this vital signs data with clinicians.

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Furthermore, Stork notifies parents when their baby turns over and sleeps with the face down, a potentially risky position for infants.

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Masimo founder and CEO Joe Kiani said: “I know how important it is for parents to better understand their baby’s physiological well-being, especially when they are sick, and it’s our privilege to provide them with an easy-to-use, accurate product that allows them to continuously monitor key vital signs for less than one-tenth of the cost I paid and also includes video surveillance.”

Masimo Stork received 510(k) clearance for prescription use, specifically for monitoring several physiological parameters as a wearable device.

It can be used for spot-checking and continuous SpO₂ and PR monitoring in neonates and infants during motion, no motion and low perfusion conditions.

Last month, the company received 510(k) clearance from the FDA for prescription and over-the-counter use of its Masimo W1 medical watch.

Masimo W1 is claimed to be the first FDA-approved watch to offer PR and continuous SpO₂ for OTC and prescription use.