Infant monitoring specialist Owlet’s Dream Sock has received CE Mark certification by the European Union, meeting its required safety and health requirements and paving the way for the device to be sold in Germany, France and the UK later this year.
The Dream Sock, which wraps around a baby’s foot, is a non-prescription medical pulse oximetry solution for infants aged 1 to 18 months weighing 6 to 30 pounds.
Caregivers can track their infant’s live health readings, including pulse rate and oxygen saturation levels, through the Owlet Dream App, which is available for iOS and Android mobile devices.
Real-time health notifications for low pulse rate, high pulse rate, low oxygen and sleep data are provided through the app.
The device also transmits data to a nearby base station, which can issue notifications to caregivers if required.
“Our mission to be there for every parent and every baby becomes even more realized with the European medical certification for Dream Sock,” Owlet CEO and cofounder Kurt Workman said in a statement.
“Parents throughout Europe will soon have access to the most innovative, consumer-friendly, medical-grade, smart baby monitoring technology so they can be more empowered to provide care from the comfort of their homes.”
THE LARGER TREND
The CE Mark certification, required under EU medical device legislation, follows the FDA’s De Novo clearance of the Dream Sock in November in the U.S.
The regulatory body also approved Owlet’s BabySat device last year, a pulse oximeter available by prescription.
The BabySat monitoring system, designed for infants aged 1 to 18 months weighing 6 to 30 pounds merges hospital-grade precision with Owlet’s wireless sock design and tracks live vital signs.
It offers customizable alarms for oxygen saturation and pulse rate, but unlike Owlet’s Dream Sock, it is available only by prescription, which allows healthcare providers to tailor alarms to individual infant needs.
Earlier this year, Owlet secured $30 million in private placement financing, which was followed in April by a partnership with telehealth staffing and services specialist Wheel, whereby caregivers can obtain a prescription for BabySat via Wheel’s online portal or clinicians.
Once prescribed, caregivers can order the sock at minimal cost through Wheel’s BabySat telehealth platform.
There is a growing number of smart devices aimed at baby monitoring, including the Miku Pro Smart Baby Monitor, a contactless breath tracking tool to help parents monitor sleep patterns and breathing, a device similar to a Nanit wearable sleep-tracker for babies.
Clinical implementation studies and telehealth platforms for remote pregnancy monitoring, virtual maternity care and breastfeeding support are also hitting the market.