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Parents will soon have access to Owlet's Dream Sock with medically-certified CE-Marking across the European markets
Owlet, Inc. ("Owlet" or the "Company") (NYSE:OWLT), the pioneer of smart infant monitoring, announces the EU medical device certification of Dream Sock. This EU-CE-Mark certification, issued by Owlet's EU notified body, signifies that Owlet's Dream Sock has been assessed and certified to meet safety and health requirements set out under EU medical device legislation. With this certification, Owlet plans to expand its medical-device product portfolio to even more caregivers around the world.
This EU medical device certification follows two marketing authorizations from the U.S. Food and Drug Administration (the "FDA"), for Dream Sock, with new medical technology for healthy infants over-the-counter without a prescription, and for BabySatⓇ, a prescription-only pulse oximeter designed for use with babies that have a pre-existing medical condition.
"Our mission to be there for every parent and every baby becomes even more realized with the European medical certification for Dream Sock," said Kurt Workman, Owlet Chief Executive Officer and Co-Founder. "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."
Dream Sock comfortably wraps around a baby's foot and is intended for routine, in-home surveillance of healthy infants by measuring oxygen saturation and pulse rate, and will provide sleep insights for parents that are new for the European markets. Its advanced technology offers clinically-proven accuracy, while the connected Owlet Dream App delivers live readings directly to a mobile device and a nearby Base Station – both of which can provide a notification to the caregiver, prompting them to assess the infant. Dream Sock, as certified for the EU, is intended for use with healthy infants between 0-18 months and 2.5-13.6 kg. Its notifications and associated data are intended to supplement the decision by caregivers to seek additional guidance for medical care of the infant. It is not intended to replace traditional methods of diagnosis and/or treatment.
While not currently available for sale, Dream Sock is expected to launch throughout Germany, France and the UK this spring, with other European countries to follow.
Posted In: OWLT
