FDA-Cleared Dream Sock

Owlet Dream Sock is the first-of-its-kind FDA-cleared smart baby monitor to offer Live Health Readings and Health Notifications for use with healthy infants between 1-18 months, 6-30 lbs. Dream Sock received a De Novo clearance from the FDA, making it the first-of-its-kind, over-the-counter, non-prescription medical pulse oximeter for infants. After rigorous testing in at-home and hospital environments, Dream Sock was determined to provide accurate data to parents, arming them with real-time Live Health Readings of vital signs and Health Notifications for low pulse rate, high pulse rate, and low oxygen in the corresponding Dream App. Since these vitals will be impacted anytime an infant’s health might become vulnerable, parents will receive actionable alerts, as opposed to just movement notifications like other infant monitors on the market. With the launch of the FDA-cleared Dream Sock, Owlet has elevated at-home monitoring and reimagined what this type of technology can look like. Caregivers no longer have to lug home and navigate complicated, clunky hospital monitoring systems to get their baby’s key vital signs. Instead, Owlet’s medical-grade, sleek devices wrap comfortably around the baby’s foot without any wires or adhesives – ensuring safe, comfortable and unrestricted movement while monitoring pulse rate, oxygen level, sleep patterns and more. Owlet’s devices also provide alerts with lights and sounds when a baby’s vital signs fall outside the normal range so parents can take action if needed. Owlet has been committed to helping all parents and caregivers monitor what matters most, empowering them with the right information at the right time. The founders were motivated to provide parents with at-home monitoring devices after experiencing first-hand the impact of sudden unexpected infant death (SUID), sudden infant death syndrome (SIDS), and other serious health conditions that cause anxiety when parents first bring their baby home. By combining advanced technology with ease of use, the company is spearheading new, medical-grade innovations in the digital health space and giving caregivers more peace of mind at home. With their suite of FDA-cleared infant monitoring devices, only Owlet is expanding accessibility and providing parents with the tools they need to confidently make decisions about their child’s health and safety.

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