Masimo secured FDA clearance for its Stork baby monitoring system that can help track certain vital signs in healthy infants up to 18 months old and provide alarms to parents or caregivers.
The newly bestowed 510(k) nod for the over-the-counter version of Masimo's Stork enables parents to buy the monitoring tech without the need for a doctor's prescription.
The OTC Stork utilizes the same Masimo pulse oximetry technology that monitors more than 10 million babies in hospitals every year and is used at nine of the top 10 U.S. hospitals, according to the company.
The FDA-cleared OTC version of Masimo Stork monitors a baby’s key vitals data including oxygen saturation level (SpO2), pulse rate (PR) and skin temperature. The tech also notifies caregivers with visual and audible alarms if a baby’s SpO2 or PR readings fall outside of preset ranges.
"I believe that by empowering parents and caregivers with the same Masimo pulse oximetry technology that hospitals have been using on babies for decades, we can help them feel more informed and confident when caring for their baby," said Joe Kiani, founder and CEO of Masimo, in a press release.
The company unveiled its Stork monitoring system last spring, sans regulatory clearance. At the time, it made sure to note that the system was “not intended for use as a medical device or to replace a medical device” nor should it be used “to diagnose, cure, treat, alleviate or prevent any disease or health condition," Fierce Medtech reported.
Masimo's smart home baby monitoring system got its initial FDA clearance in December to be used for at-home medical monitoring of babies when prescribed by a doctor.
Stork bundles are currently available at major and specialty retailers nationwide and on the company's website as a nonmedical device for general health and wellness purposes. Alongside the FDA clearance, Masimo will make Stork’s new alarm features available to all existing and new Stork users through the Masimo Stork App in an update scheduled to be released this summer.
The system centers around a flexible, medical-grade silicone boot that straps to a baby’s foot and is embedded with a sensor for continuous measurement of their SpO2, PR and skin temperature.
The soft, flexible boot comes in three sizes so it can “grow with the baby,” per Masimo.
The Stork Vitals+ bundle includes the boot with sensor that monitors baby’s skin temperature, PR and SpO2 along with a video camera. The camera hardware and software architecture are designed to leverage and be compatible with AI-based features currently in development, the company said. Masimo plans to use AI technology to help identify babies who have turned facedown.
The system comprises a handful of components that can be mixed and matched to meet parents’ needs, including a standalone audio hub if video monitoring isn’t needed, which connects the Stork vital signs sensor/boot to the Stork app. Stork also monitors the baby’s room conditions such as ambient temperature and humidity.
In March, Masimo announced plans to spin off its consumer business, including its high-tech Stork baby monitor system and its line of health-focused smartwatches.
Last year, Owlet also secured FDA clearance for its BabySat prescription-only pulse oximeter monitoring device for infants and then got another FDA nod for an over-the-counter version of the tech called Dream Sock.
And, this month, the company also notched EU medical device certification for Dream Sock, enabling Owlet to expand its medical device product portfolio.