Owlet, Inc. announces the launch and availability of Dream Sock® and BabySat?, two medical devices with recent clearances from the U.S. Food and Drug Administration (?FDA?). Both innovations deliver real-time health insights with medical-grade accuracy and unprecedented advancements for at-home infant care. Parents lose a staggering 133 nights of sleep during the first year of their newborn?s life1.

Additionally, parents will experience more than three million emergency care visits for their infants each year2, and, annually, more than two million children under the age of five have outpatient visits for respiratory syncytial virus (?RSV?). Dream Sock and BabySat are designed to arm caregivers with the tools to combat these common stressors ? being clinically proven to accurately track and display an infant?s vital signs and notify parents in real-time so they can take action if required.

Since achieving its De Novo clearance from the FDA in November 2023, Dream Sock continues to be the first-of-its-kind medical pulse oximetry solution for infants without the need for a prescription. Rigorously tested in both hospital and at-home environments and found to be compliant with all relevant performance and safety standards, the Dream Sock device provides accurate and actionable data to parents. Caregivers of healthy babies between 1-18 months and 6-30 lbs can now track their infant?s Live Health Readings, including pulse rate and oxygen saturation level, in the Owlet Dream App (iOS & Android), as well as receive real time Health Notifications for low pulse rate, high pulse rate, and low oxygen.

These features are available to both existing and new Dream Sock users who opt to enable these features in the Dream App. The BabySat pulse oximetry monitoring system combines hospital-grade accuracy with Owlet?s modern and wire-free sock design, and is intended for infants between 1-18 months and 6-30 lbs with acute or chronic medical conditions. BabySat also provides the ability to track live vital signs, but is distinct from Owlet?s Dream Sock in that it is available through prescription only, and allows a healthcare provider to set and adjust customizable alarms for oxygen saturation and pulse rate that are tailored to an infant?s individual needs.

Research shows there is a 40% decrease in mortality rates with the use of in-home pulse oximetry monitoring to track oxygen saturation levels for complex congenital heart disease in infants4. The availability of the BabySat pulse oximeter for more vulnerable infant populations better connects healthcare providers and caregivers, and ultimately allows caregivers to more confidently care for their little ones at home. BabySat will also be eligible for insurance reimbursement, increasing affordability and further democratizing access to these advanced monitoring tools.

Additional details on BabySat prescription, fulfillment, and insurance reimbursement will be announced soon.