It’s a … sensor! Masimo welcomed the newest addition to its product family this week as it unveiled the Stork health-monitoring system for babies up to 18 months old.
The system comprises a handful of components that can be mixed and matched to meet parents’ needs, including a video camera with two-way audio capabilities—or a standalone audio hub, if video monitoring isn’t needed—as well as a connected smartphone app and a sensor-equipped silicone boot. While the camera can provide readings of a room’s temperature, humidity and noise levels, the boot monitors a baby’s own vital signs, including oxygen saturation, pulse rate and body temperature.
The soft, flexible boot comes in three sizes so it can “grow with the baby,” per Masimo. Its embedded sensors can last up to 16 hours per charge and take only two hours to fully recharge.
While the most basic Stork bundle pairs only the video camera and app for a high-tech take on a classic baby monitor—and clocks in at $249—the full “Vitals+” bundle includes the camera, app and boot for $549. The bundles are already available for preorder and are due to begin rolling out next month.
As CEO and founder Joe Kiani noted in the company’s announcement this week about the new arrival, the Stork system shares its name with a project that ultimately led to the launch of Masimo’s now-flagship SET pulse oximetry technology in the late 1990s. Dubbed Project Stork and unveiled in 1992, an early proof-of-concept version of the SET tech was designed specifically to track oxygen saturation in newborns, whose uncontrollable squirming was incompatible with previous pulse oximeters.
“When we set out in 1989 to reinvent pulse oximetry, we named the project ‘Stork’ because our hope was that this technology would help reliably bring healthy babies home to their parents,” Kiani said. “With Stork’s introduction today, we’ve taken our passion for newborn care and our innovative and groundbreaking technologies to craft a solution that we hope will give parents greater insights into their babies and help them live healthier lives.”
He continued, “Parenting is the hardest thing one loves to do. With Stork, our goal is to improve the parenting experience through a seamless, thoughtful integration of advanced and trusted health technologies that bring real data to parents.”
Though the Stork sensors provide parents and caregivers with continuous readings of a baby’s vital signs, and while its app compiles those readings into longer-term trends and averages, the system hasn’t gone through the FDA review process, and Masimo notes on its website that it’s “not intended for use as a medical device or to replace a medical device.” Furthermore, the company warns users not to use the Stork tech “to diagnose, cure, treat, alleviate or prevent any disease or health condition.”
That careful distinction comes nearly two years after the FDA cracked down on a similar system from Owlet. The Smart Sock vital sign monitors were designed to track blood oxygen saturation and pulse rate in children between the ages of 0 and 5. Though Owlet, like Masimo, informed users that its products weren’t medical devices, the FDA took issue with the fact that a connected app would issue alerts if the Smart Sock’s readings left predetermined healthy ranges, therefore suggesting that a baby could potentially be experiencing desaturation or bradycardia—even as Owlet said the system shouldn’t be used to diagnose, treat or prevent any health condition.
The FDA issued a warning letter to Owlet in the fall of 2021—after what the agency described as half a decade of correspondence with the company over the issue. By the end of that year, Owlet had taken the Smart Sock off the market. It was replaced with the simplified Dream Sock, which notifies parents only when vital sign readings leave a baby’s usual baseline, though the company has since submitted for FDA review its software that issues alerts for high or low heart rate and low oxygen levels.