The Dream Sock and BabySat devices deliver real-time health insights with medical-grade accuracy for at-home infant care. They recently received FDA 510(k) clearance.
“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,” Owlet CEO and cofounder Kurt Workman said in a news release. “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.”
More about Dream Sock
Dream Sock is a medical use oximetry solution for infants without needing a prescription. It received FDA de novo clearance in November 2023. It has been rigorously tested in hospital and at-home environments. It was found to comply with all relevant performance and safety standards to bring 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.”
Owlet designed Dream Sock for healthy babies between 1 and 18 months and 6 to 30 pounds to track Live Health Readings, including pulse rate and oxygen saturation level in the company’s accompanying Dream App. It also gives caregivers real-time health notifications for low pulse rate, high pulse rate and low oxygen.
More about BabySat
BabySat is a pulse oximetry monitoring system that combines hospital-grade accuracy with Owlet’s modern and wire-free sock design. It is intended for infants between 1-18 months and 6-30 pounds with acute or chronic medical conditions.
Owlet designed the device to track live vital signs, but it is distinct from Owlet’s Dream Sock in that it is only available through prescription 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.
“The launch of BabySat is a huge accomplishment for both parents and providers to enhance care coordination outside of the hospital,” said Jim Fidacaro, SVP and GM of Owlet’s healthcare division. “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.”