Summary: Owlet Inc., a smart infant monitoring company, has received UKCA certification for its Dream Sock, following recent CE Mark certification. These certifications allow Owlet to expand its reach in key UK and European markets. Dream Sock, which wraps around a baby’s foot to monitor oxygen saturation and pulse rate, provides sleep insights for parents through the Owlet Dream App. Owlet’s certifications from the UK and EU, alongside FDA approvals in the US, position the company to broaden its market presence and enhance accessibility to its innovative baby monitoring products across Europe.
Key Takeaways:
- Owlet Inc. has received both UKCA and CE Mark certifications for its Dream Sock, allowing the company to expand its reach in the UK and European markets.
- The Dream Sock monitors a baby’s oxygen saturation and pulse rate and provides sleep insights to parents via the Owlet Dream App and a connected Base Station.
- These certifications, along with FDA approvals in the US, position Owlet to enhance its market presence and make its products more accessible to families across Europe.
Owlet Inc has received UK medical device certification for its Dream Sock, an infant monitoring device that measures oxygen saturation and pulse rate and provides sleep insights.
The UK Conformity Assessed (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 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 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.
“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 year. This represents a significant opportunity for Owlet to expand its business and reach more families with its innovative baby monitoring products,” says Jonathan Harris, Owlet president and chief revenue officer, in a release. “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.”
In-Home Infant Monitoring System
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 that are new for the UK market. Its 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.
Owlet’s Dream Sock is expected to launch at major retailers in the UK, Germany, and France in the coming months, with other European countries to follow later this summer.
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