FDA-Cleared BabySat® Monitoring System
Introducing the BabySat® monitoring system, a prescription and is intended for babies aged 1-18 months and between 6-30 lbs who could benefit from additional monitoring at home, under the supervision of a physician due to ongoing medical needs. Indications for BabySat often include babies with underlying Cardiac or Respiratory conditions.
BabySat® is FDA-cleared and clinically proven to be safe and accurate for monitoring oxygen saturation and pulse rate for infants at home.
Easy-to-use fabric sock with a smart sensor wraps comfortably around an infant’s foot without wires or adhesives, ensuring unrestricted movement while monitoring key vital signs.
Caregivers can view vital sign data from Owlet’s wearable sensor in the Owlet Care+ App. For you, the data can be integrated into the medical record with Owlet Connect to view your patients’ status remotely.
Set and adjust alarm limits based on your patient’s specific needs, and modify as needs change.
The Owlet Care+ App includes historical data for vital sign trends over time, offering valuable insights into your patient’s clinical status.
The BabySat® monitoring system is intended for infants between 1-18 months of age weighing between 6-30 pounds that a healthcare provider determines could benefit from additional monitoring at home.
Are you a caregiver?
Owlet BabySat® requires a prescription and is intended for babies aged 1–18 months and 6–30 lbs who could benefit from additional at-home monitoring, under a physician's supervision, due to ongoing medical needs. Common indications for BabySat include underlying cardiac or respiratory conditions. If these or similar concerns apply to your baby, you may request a prescription from your healthcare provider.
Learn more and prescribe today
Introducing BabySat® and Owlet Connect
Now, the FDA-Cleared, Prescription BabySat® Pulse Oximeter designed specifically for infants can automatically share vital signs through Owlet Connect, seamlessly integrated into your EMR/EHR or remote monitoring platform.
With Owlet Connect, clinicians can:
- Longitudinally monitor infant patients remotely with frequent, reliable SpO₂ and pulse rate data
- Gain timely, actionable insights from the patient's home (no additional caregiver steps required)
- Streamline workflows with automated data delivery directly to your medical record systems
To learn more about BabySat®, request a demo, or discuss how BabySat® can integrate into your workflow and support your patient care, contact us below.
Commonly asked questions about BabySat®
I am a medical provider, how can my practice get started using BabySat®?
AdaptHealth and their Sales Team are working to support you getting access to BabySat®. Follow the link here and pre-register to receive pertinent marketing collateral, and order forms/RX pads.
How is this different from Dream Sock?
BabySat® is FDA-cleared and clinically-proven to be safe and accurate for monitoring your infant's vitals at home. BabySat® requires a prescription from a healthcare provider, and may or may not be eligible for partial or full reimbursement through your health insurance plan. To find out if your insurance is accepted place an order via the online order form.
Is Dream Sock FDA-cleared?
Yes! Owlet announced FDA Clearance of Dream Sock. Dream Sock is the first and only non-prescription baby monitor with FDA-cleared Live Health Readings and Health Notifications for healthy babies between 1 to 18 months. Available to current and new Dream Sock users.
Is this the same product as Smart Sock? Is this a new Smart Sock? Is Smart Sock coming back?
BabySat® is not the same product as Smart Sock, as BabySat® is a new FDA-cleared medical device to be prescribed by healthcare providers in the US and Smart Sock is a consumer product offered only outside of the US and Canada. BabySat® provides real-time alerts if pulse rate or oxygen saturation level falls outside a prescribed zone. Unlike Smart Sock, BabySat® has adjusted reading levels and is a prescription only device that should be used in partnership with your healthcare provider.
Owlet does not anticipate marketing Smart Sock within the US or Canada in the future. Dream Sock is the first and only non-prescription baby monitor with FDA-cleared Live Health Readings and Health Notifications for healthy babies between 1 to 18 months. Available to current and new Dream Sock users.
What does BabySat® measure?
BabySat® has a rechargeable, battery-powered sensor which is secured over an infant’s foot with a fabric sock. The sensor is capable of detecting pulse rate, SpO2, and motion levels. BabySat® has customizable alarm limits for pulse rate and SpO2 which can be set to alert for critical values according to your patient’s needs. Graphs of historical vital sign data are also viewable through the Care+ App to reveal clinical trends which can help inform clinical decisions and effectively engage home caregivers in the infant’s plan of care.
Is BabySat® accurate?
BabySat® has undergone a series of rigorous accuracy testing in adult and infant study subjects. These studies were required for FDA clearance and reviewed by experts to ensure that our device meets standards set by the International Organization for Standardization. BabySat® accuracy for pulse rate and SpO2 are found in the user manual, as well as the Fact Sheet.
What is required on RX?
Here is a helpful link to showcase what is required on a prescription.
Will my insurance cover the cost?
BabySat® is currently covered by more than 300 plans, including 38 state Medicaid plans. At this time, the product can also be offered as a self-pay item, providing you have a prescription from your physician. We still encourage you to still place an order online providing your insurance information, as this will help with the process of offering it through your insurance.
What happens after my order is submitted?
Once your order is submitted, you will receive a confirmation number from AdaptHealth. This is a unique number and is associated with the account you created with them. It can be used and referenced should you have any questions related to order status, changes, modifications or if you wish to cancel. Visit AdaptHealth for more information.
How long will it take for the BabySat monitoring system to ship?
Once your order is confirmed, and all necessary documentation has been provided, your monitor will ship within 24 hours. AdaptHealth offers free 2 business day air shipping within the continental USA. Delivery times can vary based on your location. Expedited shipping is available for a fee; contact AdaptHealth for details at 800-673-3126.
NOTE: Processing times will vary based on whether a prescription/medical justification has been provided up front at time of placing your order. Being that an RX is required prior to dispensing/shipping the product, AdaptHealth will work closely with your physician. You as the patient's advocate play an integral role in helping to support this effort. We encourage you to reach out to your Physician who is following the care of your child to make sure they willingly and clinically can justify the use of the product.
Question about your order?
- My product is not working and I need support.
BabySat® is covered by Owlet's warranty policy. If you're experiencing any issues, please reach out to our customer support team and they will be ready to assist. - I received my product from AdaptHealth, and I need to return the product.
You have 10 days from receipt to return your product (reminder: once box seal is broken it is non-returnable). Visit AdaptHealth to start your return.
