Owlet Granted FDA-Clearance for Its Pulse Oximetry Sock for Infants

By Published On: July 6th, 2023

This exciting announcement comes after nearly two years of collaboration between the brand and the Food and Drug Administration.

In 2015, Owlet became a well-known brand in the baby space with the launch of its original Smart Sock, designed to monitor a sleeping baby’s oxygen level and pulse rate (and put parents’ minds at ease). It was hugely popular with caregivers, but in October 2021, the company received a warning from the Food and Drug Administration (FDA) for failing to market the Smart Sock models with proper clearance. The following month, Owlet abruptly discontinued sales of the products and returned to the drawing board, leaving many families sorely disappointed. Now, expectant parents who are hopeful to use an Owlet sock to monitor their child may be in luck. 

While there’s a lot of buzz about BabySat (and for good reason), parents in need of a monitor now should know that Owlet currently offers the Dream Sock, a sleep-tracking system that monitors an infant’s heart rate and average oxygen as indicators of sleep quality (versus vitals), as well as wakings, movement, and other factors. While the Dream Sock is helpful for understanding your baby’s resting patterns and establishing a sleep routine, it’s still just that—a sleep monitor. But the heart behind Owlet’s mission is rooted in providing parents with a better product for monitoring their child’s health and safety, which is where BabySat is entering the scene. 

Thanks to its recent FDA approval, BabySat will be available via prescription later this year. Here’s what we know about this innovative product and what to do if you want to use it with your baby.

What Is BabySat?

BabySat is the first FDA-cleared infant pulse oximetry medical device featuring Owlet’s modern, wire-free sock design. “Pulse oximetry” is a painless, noninvasive method of measuring oxygen saturation (SpO2) in a person’s blood. This saturation is a crucial measure of how well the lungs are working to supply the body with continuous oxygen; with BabySat, when these readings fall outside physician-recommended ranges, parents and caregivers are immediately alerted. While pulse oximetry medical devices are typically used in hospitals and doctor’s offices, a BabySat prescription will offer hospital-grade monitoring accuracy at home while still under the supervision of a medical provider.

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

According to the press release, innovation in the baby care space is vital because health care providers need solutions for reducing pressure on valued medical resources. “There are roughly 92 million infant care visits covering a child’s first four years of life, significantly straining the availability of hospital beds and quality of care.” With BabySat, parents can feel confident in the care of their child at home thanks to access to critical health information about their baby.


When Will BabySat Be Available?

Owlet’s BabySat will be available exclusively in the U.S., with an estimated launch in late 2023. Because it is a medical device, a prescription is required to buy BabySat. In addition to product availability later this year, Owlet also anticipates insurance options in the future, including reimbursements and HSA/FSA eligibility.

You can learn more about BabySat here, and sign up for Owlet’s email notifications to stay informed of the product’s official release and other important updates.