Toddler monitoring specialist Owlet’s Dream Sock has obtained CE Mark certification by the European Union, assembly its required security and well being necessities and paving the way in which for the system to be offered in Germany, France and the UK later this 12 months.
The Dream Sock, which wraps round a child’s foot, is a non-prescription medical pulse oximetry resolution for infants aged 1 to 18 months weighing 6 to 30 kilos.
Caregivers can observe their toddler’s reside well being readings, together with pulse fee and oxygen saturation ranges, by means of the Owlet Dream App, which is offered for iOS and Android cell gadgets.
Actual-time well being notifications for low pulse fee, excessive pulse fee, low oxygen and sleep knowledge are supplied by means of the app.
The system additionally transmits knowledge to a close-by base station, which might challenge notifications to caregivers if required.
“Our mission to be there for each mother or father and each child turns into much more realized with the European medical certification for Dream Sock,” Owlet CEO and cofounder Kurt Workman mentioned in a press release.
“Mother and father all through Europe will quickly have entry to essentially the most modern, consumer-friendly, medical-grade, sensible child monitoring expertise to allow them to be extra empowered to offer care from the consolation of their properties.”
THE LARGER TREND
The CE Mark certification, required below EU medical system laws, follows the FDA’s De Novo clearance of the Dream Sock in November within the U.S.
The regulatory physique additionally permitted Owlet’s BabySat device final 12 months, a pulse oximeter out there by prescription.
The BabySat monitoring system, designed for infants aged 1 to 18 months weighing 6 to 30 kilos merges hospital-grade precision with Owlet’s wi-fi sock design and tracks reside important indicators.
It affords customizable alarms for oxygen saturation and pulse fee, however in contrast to Owlet’s Dream Sock, it’s out there solely by prescription, which permits healthcare suppliers to tailor alarms to particular person toddler wants.
Earlier this 12 months, Owlet secured $30 million in non-public placement financing, which was adopted in April by a partnership with telehealth staffing and services specialist Wheel, whereby caregivers can acquire a prescription for BabySat through Wheel’s on-line portal or clinicians.
As soon as prescribed, caregivers can order the sock at minimal price by means of Wheel’s BabySat telehealth platform.
There’s a rising variety of sensible gadgets aimed toward child monitoring, together with the Miku Professional Sensible Child Monitor, a contactless breath monitoring instrument to assist mother and father monitor sleep patterns and breathing, a tool just like a Nanit wearable sleep-tracker for babies.
Medical implementation research and telehealth platforms for remote pregnancy monitoring, virtual maternity care and breastfeeding support are additionally hitting the market.
