Owlet, the pioneer of smart infant monitoring, has received UK medical device certification, following the recent achievement of CE Mark certification. This marks a significant milestone for Owlet, moving the company forward in its mission to increase access to medical-grade infant monitoring technology to parents and caregivers around the world.
The UKCA certification, granted by a recognized UK-approved body, follows the recent announcement of Owlet’s EU CE mark certification of Dream Sock earlier this month and now provides Owlet with medical device certifications in key UK and European markets where its distribution partners operate.
These certifications also follow the Company’s 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.
“With the addition of the UKCA certification, Owlet is now able to increase its reach throughout the European market, where more than 3.8 million babies are born each year1. This represents a significant opportunity for Owlet to expand its business and reach more families with its innovative baby monitoring products,” said Jonathan Harris, Owlet President and Chief Revenue Officer. “Owlet is extremely well-positioned to take advantage of both the UKCA and EU medical certifications with key retail partnerships across the European market. These partnerships will allow the Company to reach a wider range of consumers and make its products more accessible to families in the region.”
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 UK market. 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 UK, 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.
Source: Company Press Release
