Owlet has launched Dream Sock, a smart baby monitor, in the UK and Europe.
The CE-marked device wraps around a baby's foot and provides real-time monitoring of vitals including pulse rate and oxygen saturation levels.
In addition, the device can monitor a baby’s sleep and waking patterns, enabling it to offer users predictive sleep and wake windows for their baby.
According to Owlet, the device is clinically proven to accurately track and display an infant’s vital signs, even through gentle motions.
By syncing with the Owlet Dream App– the Dream Sock can deliver live health readings to mobile phones and the included Base Station.
According to Utah-based Owlet, consumer infant health and sleep data it has collected since it was founded in 2012, has informed the development of its Dream Sock.
“Owlet continues to use this data to inform future offerings and develop software and digital data solutions to bridge the current healthcare gap between hospital and home and bring new insights to parents and caregivers globally,” Owlet CEO Kurt Workman told Medical Device Network.
In 2021, Owlet’s then named Owlet Smart Socks were removed from sale in the US after the US Food and Drug Administration (FDA) issued a warning letter to the company. The FDA stated that Owlet was marketing its product without the relevant clearance or approval required from the agency.
The FDA pointed out that the socks were intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, and therefore required application for premarket approval (PMA) in relation to section 515(a) of the Act, 21 U.S.C. § 360e(a).
In November 2023, Owlet obtained De Novo FDA-Clearance for its socks under the new Dream Sock name.
Growing at a CAGR of 2.6%, the Patient Monitoring Market is anticipated to reach a value of $21.38bn in 2030, up from around $18bn in 2023, as per GlobalData’s Market Size & Growth database.
