In June, we announced clearance from the U.S. Food and Drug Administration (“FDA”) of BabySat™, Owlet’s first pulse-oximetry medical device featuring its advanced, wire-free sock design. As a leader in infant health and monitoring, the addition of BabySat combines Owlet’s consumer-first expertise with hospital-grade monitoring accuracy. Below are some frequently asked questions about BabySat – and make sure you’re signed up for email notifications to receive the latest updates on product availability, pricing, and more.
What is the functionality of BabySat?
BabySat uses pulse oximetry technology to track pulse rate and oxygen saturation level in real time, and will alert caregivers when those readings fall outside ranges set by a physician.
When will BabySat be available?
BabySat availability is targeted for later this year and further details will be announced soon! The best way to stay up to date on the latest about availability, pricing and more is to register for email notifications! You can sign up here.
Do you need to have a prescription to use BabySat? What will the prescription requirements be?
Yes, you will need a prescription from your healthcare provider to use BabySat. We will provide more information on instructions and requirements as soon as we’re able!
If you’re not able to obtain a prescription when BabySat is available, we encourage you to give Dream Sock® a try! Dream Sock tracks sleep quality indicators such as heart rate, average oxygen, movements and wakings, and will send a real-time prompt to the caregiver if Baby’s baseline significantly changes. You can use HSA/FSA funds for Dream Sock, or can select a payment plan option at checkout!
How much will it cost?
We’re still working on pricing and cost, taking into account implications of potential insurance reimbursements as well. Our goal is that all parents have access to products they need to monitor their baby at home and we’re actively working to make this possible!
What ages can BabySat be used for?
BabySat is cleared for use with babies 1 to 18 months (6-30 lbs).
What is the difference between BabySat and Dream Sock?
The main difference is that BabySat is a prescription only, medical device intended for babies that a healthcare provider determines could benefit from additional monitoring at-home under the supervision of a physician. Dream Sock is our award-winning consumer product, intended to assist caregivers in tracking their child’s well-being by monitoring sleep patterns, quality and duration of sleep. Learn more about the differences here.
We also submitted Owlet’s Health Notifications software as a medical device technology for regulatory clearance by the FDA (see announcement here), and are hopeful that this software will be available as a medical device function for our Dream Sock product line in the future!
Will my current Owlet product still work?
Yes! You can continue to use your current Owlet product. BabySat is a new FDA-cleared medical device to be prescribed by healthcare providers. Dream Sock is our award-winning consumer product designed for use with healthy babies to give parents peace of mind while they sleep and we will continue to have this available for caregivers in the US and Canada.
You can learn more about BabySat and sign up for email notifications here. Please reach out to our Support Team at contact@owletcare.com with any additional questions.
