Sam Brusco, Associate Editor05.02.24
Owlet has obtained EU medical device certification for its Dream Sock smart infant monitoring device.
The certification follows a U.S. Food and Drug Administration (FDA) de novo approval in the U.S. for Dream Sock, with new technology for healthy infants over-the-counter without a prescription. The company also recently gained an FDA nod for BabySat, a prescription-only pulse oximeter for babies with 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 isn’t currently available for sale in the EU but the company expects to launch it throughout Germany, France, and the UK this spring, with other European countries to follow.
“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’s CEO 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.”
The connected Owlet Dream App delivers live readings to a mobile device and nearby Base Station. Both of these can issue a notification to the caregiver, prompting them to assess the infant. Dream Sock is meant for use with healthy infants between 0-18 months and 2.5-13.6 kg.
The certification follows a U.S. Food and Drug Administration (FDA) de novo approval in the U.S. for Dream Sock, with new technology for healthy infants over-the-counter without a prescription. The company also recently gained an FDA nod for BabySat, a prescription-only pulse oximeter for babies with 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 isn’t currently available for sale in the EU but the company expects to launch it throughout Germany, France, and the UK this spring, with other European countries to follow.
“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’s CEO 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.”
More about Dream Sock
Dream Sock comfortably wraps around a baby's foot and is used for routine, in-home surveillance of healthy infants by measuring oxygen saturation and pulse rate. The company said it will offer sleep insights for parents that are new for the European markets.The connected Owlet Dream App delivers live readings to a mobile device and nearby Base Station. Both of these can issue a notification to the caregiver, prompting them to assess the infant. Dream Sock is meant for use with healthy infants between 0-18 months and 2.5-13.6 kg.