Smart infant monitoring company Owlet Inc announced the launch and availability of Dream Sock and BabySat, two medical devices with recent clearances from the US Food and Drug Administration (FDA). Both devices deliver real-time health insights for at-home infant care.

According to a survey, parents lose 133 nights of sleep during the first year of their newborn’s life. Additionally, parents will experience more than 3 million emergency care visits for their infants each year, and, annually, more than 2 million children under the age of 5 have outpatient visits for respiratory syncytial virus. 

“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,” according to a release from Owlet.

FDA-Cleared Dream Sock

Dream Sock, which received De Novo clearance from the FDA in November 2023, offers a medical pulse oximetry solution for infants without the need for a prescription. The device was tested in both hospital and at-home environments and found to be compliant with all relevant performance and safety standards.

“Dream Sock is a breakthrough product for the industry and expands our medical-grade monitoring technology to all consumers,” says Alisa Niksch, MD, pediatric cardiologist and senior director of medical affairs at Owlet, in a release. “This device will equip parents of otherwise healthy babies with the real-time data they need to make informed care decisions for their infants.”

Caregivers of healthy babies between 1-18 months and 6-30 pounds can track their infant’s Live Health Readings, including pulse rate and oxygen saturation level, in the Owlet Dream App (iOS and 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.

FDA-Cleared BabySat

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 pounds with acute or chronic medical conditions. 

BabySat, which received FDA clearance in June 2023, 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 infants. BabySat will also be eligible for insurance reimbursement. Additional details on BabySat prescription, fulfillment, and insurance reimbursement will be announced soon, according to a release from the company.

“The launch of BabySat is a huge accomplishment for both parents and providers to enhance care coordination outside of the hospital,” says Jim Fidacaro, Owlet senior vice president and general manager of healthcare, in a release. “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.”

Photo caption: Dream Sock

Photo credit: Owlet