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     133  0 Kommentare Owlet Transforms Infant Care with the Launch of Two FDA-Cleared Devices – Dream Sock and BabySat

    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.

    FDA-Cleared Dream Sock

    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.”

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    Owlet Transforms Infant Care with the Launch of Two FDA-Cleared Devices – Dream Sock and BabySat 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 …