Available over-the-counter, Dream Sock is designed for routine in-home monitoring of oxygen saturation and pulse rate in infants.
RT’s Three Key Takeaways:
- Dream Sock is designed to monitor infants’ oxygen saturation and pulse rate, providing caregivers with real-time insights into their child’s well-being through the Owlet Dream app.
- Owlet Inc’s Dream Sock has received medical device certification from the European Union, allowing the company to market and distribute the device across Europe.
- Following its approval, Owlet plans to launch the Dream Sock in Germany, France, and the United Kingdom this spring, with further expansion to other European countries anticipated.
Smart infant monitoring company Owlet Inc has received the European Union (EU) medical device certification for its Dream Sock, a medical-grade pulse oximetry solution for infants.
This EU CE-Mark certification 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 worldwide.
This EU medical device certification follows two marketing authorizations from the US Food and Drug Administration 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,” says Kurt Workman, Owlet chief executive officer and co-founder, in a release “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 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 for the European markets. Its technology offers clinically proven accuracy, while the connected Owlet Dream app delivers live readings 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 United Kingdom this spring, with other European countries to follow.
Photo 107846158 © Joop Kleuskens | Dreamstime.com
