We have been testing Owlet devices for years and have followed their journey from being just a smart baby device to a certified medical device. And here at the CES Show 2024, one of the pioneers of smart infant monitoring launched two FDA-cleared devices that will revolutionize infant care, Dream Sock and BabySat. These cutting-edge devices empower caregivers with real-time health insights, medical-grade accuracy, and unprecedented advancements in at-home infant care.

Owlet's CEO and Co-Founder, Kurt Workman, expressed the company's commitment to providing parents clarity and peace of mind while setting new industry standards in infant care. Dream Sock and BabySat are designed to alleviate common parental stressors, offering clinically proven solutions that accurately track and display an infant's vital signs in real time, providing parents with immediate alerts when necessary.

Owler's FDA Cleared Dream Sock provides real-time health insights for parents and doctors.owlet

Addressing Parental Concerns

According to a survey, parents lose a staggering 133 nights of sleep during the first year of their newborn's life. Additionally, parents experience more than three million emergency care visits for their infants each year, with over two million children under the age of five having outpatient visits for respiratory syncytial virus ("RSV"). Dream Sock and BabySat aim to equip caregivers with the tools to address these concerns effectively.

FDA-Cleared Dream Sock

Owlet FDA-Cleared Dream SockGearBrain

Dream Sock, which received DeNovo clearance from the FDA in November 2023, represents a breakthrough in doesn'tmonitoring. It is the first-of-its-kind medical pulse oximetry solution for infants that doesn't require a prescription. Extensively tested in hospital and at-home settings, Dream Sock complies with all relevant performance and safety standards, providing accurate and actionable data to parents.

Dr. Alisa Niksch, Pediatric Cardiologist and Senior Director of Medical Affairs at Owlet, emphasized Dream Sock’s significance as it equips parents with real-time data on their infant's health. “Dream Sock is a breakthrough product for the industry and expands our medical-grademonitoring technology to all consumers. 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.”

The device allows caregivers to track their infant’s Live Health Readings, including pulse rate and oxygen saturation levels, via the Owlet Dream App (available for iOS & Android). It also provides real-time Health Notifications for low pulse rate, high pulse rate, and low oxygen, offering peace of mind to parents.

Buy Owlet FDA-Cleared Dream Sock

FDA-Cleared BabySat

Owlet FDA-Cleared BabySatGearBrain

BabySat, another FDA-cleared device, combines hospital grade accuracy with Owlet’s modern, wire-free sock design. Designed for infants between 1-18 months and 6-30 lbs. with acute or chronic medical conditions, BabySat is available through prescription only. It allows healthcare providers to set and adjust customizable alarms for oxygen saturation and pulse rate tailored to an infant’s individual needs.

Research indicates that in-home pulse oximetry monitoring reduces infant mortality rates by 40% for complex congenital heart disease. BabySat, which is eligible for insurance reimbursement, facilitates better care coordination between healthcare providers and caregivers, giving parents greater confidence in monitoring their infants at home.

Jim Fidacaro, Owlet Senior Vice President and General Manager of Healthcare highlighted the significance of BabySat in enhancing care coordination beyond the hospital, empowering parents of infants with health conditions to take control of their child's well-being. “The launch of BabySat is a huge accomplishment for both parents and providers to enhancecare coordination outside of the hospital. 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.”

Buy Cleared BabySat

Owlet remains committed to offering products that set new standards in infant care, combining advanced technology with ease of use to provide caregivers with peace of mind while monitoring their infants. For more information about Dream Sock and BabySat and to determine which product is right for your family, visit Owlet site..

And if you need help finding other smart baby devices, you can use our product find engine. It can help you find, buy, and connect any smart device, including ones compatible with your existing smart home devices, Google Assistant, and Amazon Alexa enabled devices.

Like GearBrain's content? Be sure to follow us.