Masimo nabs FDA nod for health-tracking baby monitor system

It’s a baby (monitor) boom! Shortly after Owlet secured a long-awaited FDA clearance for its baby-monitoring “sock” equipped with pulse oximetry technology—which was followed just last month by another FDA nod for an over-the-counter version of the tech—Masimo has followed suit.

The pulse oximetry giant unveiled its Stork monitoring system this 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.”

The newly bestowed 510(k) nod gives the system’s health-tracking features more weight, as it may now be used for at-home medical monitoring of babies when prescribed by a doctor, according to Masimo’s announcement this week.

Meanwhile, the system can still be purchased over the counter, without a prescription, for non-medical use.

The Stork monitor is designed to help track certain vital signs in healthy and sick babies up to 18 months old. 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 blood oxygen saturation, pulse rate and skin temperature.

Though both the prescription and over-the-counter versions of the technology can capture those round-the-clock measurements, only the former is cleared to send out alerts to a baby’s caregivers when any of the readings leave healthy parameters, or when a baby turns and begins sleeping facedown.

Users of the prescription-only system will also be able to share the Stork system’s data directly with their baby’s doctors.

Masimo noted that caregivers interested in accessing the FDA-cleared features can discuss the technology either with their child’s doctor or with a telehealth physician via the Stork mobile app, the latter of which will be available in a “soon-to-be-released update,” per the company.

In addition to the boot—which comes in three sizes to keep up with babies’ growth spurts—the Stork system can be combined with either a camera for video monitoring or an audio-only “health hub.”

Masimo didn’t disclose the cost of the prescription-only system, but the OTC version retails on its website in bundles priced at $349 to $549 for the audio-only and video-streaming versions, respectively. Joe Kiani, the company’s CEO, suggested in this week’s announcement that the FDA-cleared version will fall somewhere in that range.

“When my son was born, we were concerned about his breathing. Our doctor prescribed pulse oximetry monitoring for a week for him. A therapist arrived at our home with a large standalone pulse oximeter made for hospitals, with cables and wires everywhere and tethered to our son, and charged us $5,000 for a week of monitoring,” he said.

“I know how important it is for parents to better understand their baby’s physiological well-being, especially when they are sick, and it’s our privilege to provide them with an easy-to-use, accurate product that allows them to continuously monitor key vital signs for less than one-tenth of the cost I paid, and also includes video surveillance,” Kiani continued.