Health Devices

Owlet Gets FDA-Clearance for First Prescription Pulse Oximetry Sock for Infants

Now parents can get a a real-time medical-grade infant monitoring device to be used in your home.

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One of the first smart baby devices we tested at GearBrain was Owlet's Sock. (Here is a link to our review.). At this time, Owlet only offered their smart sock and a base station that communicated with the sock. This was the first wearable technology (sock) fitted snugly over your child's foot to track heart rate and oxygen levels. All information from the sock was wirelessly relayed from the base station to an iOS app on your smartphone and iPad. Android devices did not support Owlet until a few months later. Today the company offers a variety of smart baby devices, including a 1080p H.D. baby monitoring camera, a 3rd Gen version of its sock, and a robust app. However, the best new product is BabySat, the first FDA-Clearance medical pulse-oximetry device featuring its advanced, wire-free sock design.

How big is this news? It's enormous, and we know because we tested Owlet smart baby monitoring devices over the years, and the common question we heard from users and doctors was about how accurately the Owlet sock collected the data. Did it precisely read the baby's heart rate and oxygen readings? Today that is all cleared up thanks to the U.S. Food and Drug Administration ("FDA"). They have announced clearance for BabySat to be used by hospitals to treat high-risk babies who need to be monitored 24/7. The FDA Cleared status also allows your physician to prescribe if required, which you can then file with your insurance company for possible reimbursement. This means BabySat can be used as a real-time medical-grade infant monitoring device in your home, and you can share the data with your physician.

"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."

a photo of owlet sock on a baby's footOwlet Sock is in its 3rd Generation and still a very good smart baby wearable.GearBrain

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, roughly 92 million infant care visits cover 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 same 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 can feel confident in providing at-home care for their families–helping to reduce the strain on our valued medical resources.

Adding the FDA-cleared BabySat device expands 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:

What does all this mean for existing customers of Owlet? Will my existing Owlet sock be considered FDA Cleared? Or do I have to buy BabySat to get the medical-grade benefits? That is to be determined. We spoke with the company recently, and they mentioned they are still working on plans to help existing customers take advantage of their new FDA Cleared status, but they hope to have an answer later this year. We will keep you posted on this front.

In the interim, we congratulate Owlet on getting FDA Clearance for their smart sock. Taking the guesswork out of the data and knowing the medical grade readings your doctor can use is excellent. We look forward to testing the new BabySat once it's available in the U.S. and ready for mass use.

And if you need help finding other smart baby devices, check out The GearBrain, our compatibility product find engine. If will help you find, buy and connect any smart device, including devices compatible products with your existing smart home system.

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