Masimo Receives FDA Clearance for Baby Monitoring System

Stork is a wearable device intended for the monitoring of multiple physiological parameters.

Ch Press Release Image Stork Fda 568694 0923

Masimo announced today FDA clearance of Stork, a baby monitoring system, for prescription use with healthy and sick babies 0-18 months of age. Leveraging the same Masimo sensor technology that monitors more than 10 million babies in hospitals every year, Stork provides continuous, accurate monitoring of a baby’s health. Stork is available at retailers nationwide as a non-medical device for general health and wellness purposes. With this clearance, Stork is now available for prescription use to continuously monitor babies at home as a medical device for healthy or sick babies.

When prescribed, parents and family members will now be able to receive alarms regarding their baby’s oxygen saturation (SpO2), pulse rate (PR), and skin temperature. They will be able to share these vital signs data remotely with clinicians. In addition, Stork alerts parents if their baby turns over and is sleeping face down, which can be dangerous for babies.

Stork uses the same technology that has been used on babies in the neonatal intensive care unit (NICU) for years, 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. Stork’s SpO2 performance specification is industry-leading, at 1.5% ARMS at one standard deviation, even during motion.

This patented 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 non-invasive monitoring to detect babies’ SpO2, PR, and skin temperature continuously with unprecedented accuracy and dependability.

With a sleek, minimalistic design ideal for any nursery aesthetic, the Stork Vitals+ bundle includes the boot with sensor that monitors baby’s skin temperature, pulse rate, and oxygen saturation, 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, in development. For those who do not require streaming video, the Stork Vitals bundle replaces the camera with a health hub, which connects the Stork vital signs sensor/boot to the Stork app, while still allowing parents to hear and speak to their baby. Stork also monitors the temperature of the baby’s room.

For non-medical use, Masimo Stork bundles are available for direct consumer purchase at and on shelves at major and specialty U.S. retailers. To access Masimo Stork’s FDA-cleared features, parents can discuss Stork with their child’s primary care physician or, in a soon-to-be-released update, online with a physician via the Masimo Stork App.

More in Devices