The US Food and Drug Administration has cleared BabySat, a medical pulse-oximetry device featuring a wire-free sock design by Owlet, a provider of baby monitoring solutions.

According to a release from Owlet, BabySat combines consumer-first expertise with hospital-grade monitoring accuracy.

“Our mission is to provide caregivers with the right information at the right time to make informed decisions about their baby’s health,” says Kurt Workman, CEO and co-founder, in a release. “Today, parents whose babies need additional monitoring are sent home with traditional solutions that can be restrictive and more cumbersome for parents. BabySat pushes forward the modernization of hospital-grade technology for at-home use and underscores our commitment to transforming baby care solutions.”

Innovation in the baby care space matters because some of the largest issues facing caregivers and healthcare providers have yet to be solved, according to a release from Owlet. For example, 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.

BabySat is a step forward in solving some of these challenges by bringing real-time, medical-grade infant monitoring into the home, while under the supervision of a physician. Available through prescription, BabySat uses pulse oximetry technology to provide a real-time display of their baby’s heart rate and oxygen saturation level and alerts parents when these readings fall outside of prescribed ranges. With access to this information and under the supervision of a physician, caregivers are enabled to feel confident in providing at-home care for their families, helping to reduce the strain on medical resources.

BabySat will be available in the US only and is targeted to launch later this year.

Photo caption: Owlet’s BabySat is now FDA-cleared.

Photo credit: Owlet