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MagyarMasimo Stork wearable baby bootie acquires FDA clearance for remote vitals monitoring
Masimo has received FDA clearance for its Stork baby monitoring system. The core of this system is the Stork Boot, a wearable bootie for babies that monitors oxygen saturation, pulse rate, and skin temperature.
Without a prescription, vital signs are continuously transmitted from the Boot to smartphones so parents can monitor babies on their own. A prescription adds alarms that eliminate the need to constantly watch for abnormal vitals and allows physicians to receive vital sign data for remote healthcare.
The bootie will also alert parents when their baby has flipped over and is sleeping face down. Babies under 1 year old can breathe in excessive carbon dioxide when their faces are buried in bedding, and the resulting grogginess prevents them from turning their heads for air. This is one suspected cause of sudden infant death syndrome. Physicians suggest putting the baby on its back in a baby crib with a firm mattress (like this one at Amazon) to help prevent SIDS.
The Stork Boot is made of silicone and sized for babies up to 18 months old. A rechargeable battery powers the bootie for 16 hours and can be recharged in 2 hours. An upgraded package comes with a high-definition video camera for continuous video monitoring. The Stork system is now available at Amazon without prescription or remote vitals monitoring. Prescription use and monitoring will be added in 2024.
Source(s)
Masimo Receives FDA Clearance for Stork™ Baby Monitoring System
Masimo Announces FDA Clearance of Stork for Prescription Use with Babies 0-18 Months of Age.
Prescription Use of Stork Provides Alarms When Baby’s Oxygen Saturation and Pulse Rate Are Abnormal
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 through the Stork app regarding their baby’s oxygen saturation (SpO2), pulse rate (PR), and skin temperature. In addition, they will be able to share vital signs data remotely with clinicians. Stork also alerts parents if their baby turns over and is sleeping face down, which can be dangerous for babies.
Alongside this clearance, Stork’s software is being upgraded for all applicable users* with a key additional feature, the ability to review historical video footage of their baby, in addition to tracking trends in vital signs data. Additionally, Stork will offer instant access to a library of informative articles designed to educate new parents about the baby’s health and well-being. More details for prescription use of Stork are coming in 2024.
For non-medical use, Masimo Stork bundles continue to be available for purchase here, at MasimoStork.com, and on shelves at major and specialty U.S. retailers.
To access Masimo Stork’s FDA-cleared features, parents should discuss Stork with their child’s primary care physician.
Masimo's 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.
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 sensor embedded in the boot is the product of meticulous engineering that harnesses decades of expertise in non-invasive monitoring to detect babies’ oxygen saturation (SpO2), pulse rate (PR), and skin temperature continuously with unprecedented accuracy and dependability.
*Historical video footage available only to Stork Vitals+ and Stork Camera owners. Vital signs data trends available only to Stork Vitals+ and Stork Vitals owners.
Note: The camera requires internet connection. Phone not included.
PLCO-006972/PLM-14950A-1223
