After FDA rebuke, Owlet relaunches baby-monitoring 'sock' with agency's blessing

Nearly two years ago, Owlet pulled its Smart Sock from the market after the FDA issued a warning letter condemning the unregulated device’s use in alerting parents when their babies’ heart rates or blood oxygen levels left predetermined healthy ranges.

Owlet had warned customers that its monitoring system wasn’t a medical device and shouldn’t be used to “diagnose, cure, treat, alleviate or prevent any disease or health condition or investigate, replace or modify anatomy or any physiological process,” but the FDA suggested that the alerts could still lead parents and healthcare providers to infer that a baby was experiencing desaturation or bradycardia, and so the devices did indeed need to be reviewed by the regulator.

Now, however, Owlet has made good: The baby monitor maker announced this week that it has earned the agency’s clearance for a new version of the alert-sounding system, dubbed BabySat.

Like the Smart Sock before it, BabySat centers around a flexible, sensor-equipped sock that wraps around a baby’s foot. It uses pulse oximetry technology to track both oxygen saturation levels and heart rate, and sends real-time alerts to a connected smartphone app if those readings leave certain parameters.

Unlike the Smart Sock, however, BabySat requires a prescription from a doctor to use. It’s designed for babies who may need extra monitoring, and doctors can set the vital sign ranges that will guide the device’s alerts.

“Today, parents whose babies need additional monitoring are sent home with traditional solutions that can be restrictive and more cumbersome for parents,” Owlet CEO Kurt Workman said in the announcement. “BabySat pushes forward the modernization of hospital-grade technology for at-home use and underscores our commitment to transforming baby care solutions.”

With FDA clearance now secured, Owlet said it plans to launch the BabySat system in the U.S. later this year. The company didn’t disclose how much the system will cost—though the Smart Sock previously retailed for $300, the same price as Owlet’s current Dream Sock device—but notes on its website that it could potentially be covered by insurance, with more information on reimbursement expected later this year.

And Owlet isn’t stopping there. Next up, it’s hoping to secure FDA clearance for the Dream Sock system, for which it submitted a de novo application at the end of last year.

Like the original Smart Sock, the current over-the-counter Dream Sock system is meant to be used only as a high-tech baby monitor, allowing parents to track certain “sleep quality indicators” in healthy babies. It, too, uses pulse oximetry tech to track those data, which include heart rate, oxygen levels, wake-ups and movements.

As it currently stands, the Dream Sock is “not a medical device and therefore does not require FDA clearance,” per Owlet, but the company has submitted the de novo clearance request in hopes of adding live displays of heart rate and oxygen saturation readings to the system, as well as alerts when those vital signs move beyond preset ranges.