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These new, innovative devices empower caregivers to monitor what matters most with reliable, medical-grade technology.
Owlet, Inc. ("Owlet" or the "Company") (NYSE:OWLT), the pioneer of smart infant monitoring, today 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.
"We are on a mission to help parents monitor what matters most and are proud to now offer two FDA-cleared, at-home infant monitors to countless parents who want and need more information on their baby's well-being," said Kurt Workman, Owlet Chief Executive Officer and Co-Founder. "Both the FDA-cleared Dream Sock and BabySat devices are a representation of our endless commitment to providing clarity and peace of mind for parents, while also setting new standards in the industry of infant care."
According to a survey, 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")3. 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.
"Dream Sock is a breakthrough product for the industry and expands our medical-grade monitoring technology to all consumers," said Dr. Alisa Niksch, Pediatric Cardiologist and Senior Director of Medical Affairs at Owlet. "This device will equip parents of otherwise healthy babies with the real-time data they need to make informed care decisions for their infants. Owlet is dedicated to advancing the capabilities of Dream Sock to enhance care for infants in the home."
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.
"The launch of BabySat is a huge accomplishment for both parents and providers to enhance care coordination outside of the hospital," said Jim Fidacaro, Owlet Senior Vice President and General Manager of Healthcare. "It extends medical-grade, personalized infant care to the home environment, and with oversight from a physician, parents of babies with health conditions can feel more in control of their little one's well-being."
Owlet is committed to offering products that set a new standard in infant care, combining advanced technology with ease of use to help caregivers have increased peace of mind while monitoring what matters most. For more details on each device and to find out which product is the right choice for your family, visit www.owletcare.com.
Posted In: OWLT
