Owlet announces clearance from the U.S. Food and Drug Administration (“FDA”) of BabySat™, the first medical pulse-oximetry device featuring its advanced, wire-free sock design. Owlet is a leader in infant health data, having monitored more than 1 million babies, and with BabySat, combines its 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,” said Kurt Workman, Chief Executive Officer and Co-Founder. “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. 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 exact 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 (SpO2) 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 our valued medical resources.
The addition of the FDA-cleared BabySat device expands on Owlet’s existing portfolio of consumer products designed to bring peace of mind to caregivers. BabySat will be available in the U.S. only and is targeted to launch later this year. Customers can learn more and sign up to receive the latest information and details on product availability here: https://www.owletcare.com/babysat-fda-clearance