The US Food and Drug Administration has granted 510(k) clearance to Masmio’s Stork, a baby monitoring system, for prescription use with healthy and sick babies 0-18 months of age. The system provides continuous monitoring of oxygen saturation, pulse rate, and skin temperature.

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.

When prescribed, parents and family members will now be able to receive alarms regarding their baby’s oxygen saturation, pulse rate, 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 leverages the same technology that has been used on babies in the neonatal intensive care unit for years, according to a release from Masimo. 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.

The patented sensor technology nests within the Stork boot, which is made from medical-grade silicone that conforms to the baby’s skin and is available in three sizes.

“I had the privilege of having access to one of the earliest Masimo SET pulse oximeters,” says Mitchell R. Goldstein, MD, professor of pediatrics at Loma Linda University, in a release. “A young baby, Joshua, came to our unit at extremis, and we attempted all life-saving measures to get his pulse on a non-Masimo device. With no success, we then tried the Masimo monitor and were able to get readings of his vitals, a signal that we should continue to provide care. Joshua survived and was eventually sent home with his parents, and our unit has relied on Masimo SET ever since.

“It is the only pulse oximeter I’m aware of that has provided the ability from the beginning to measure through challenging conditions and with darker skin colors, as was the case with Joshua. I am glad to see this life-saving technology being expanded to the home.”

The Stork Vitals+ bundle includes the boot with sensor that monitors the baby’s skin temperature, pulse rate, and oxygen saturation, and a 2K quad high-definition-capable camera. The camera hardware and software architecture are designed to leverage and be compatible with future artificial intelligence-based features that are 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.

Photo caption: Masimo Stork

Photo credit: Business Wire