Digital parenting platform solutions provider Owlet has received De Novo clearance from the US Food and Drug Administration (FDA) for its medical pulse oximetry solution, Dream Sock, for infants.
The over-the-counter (OTC) oximetry solution is designed to monitor and display a baby’s live health readings and enable caregivers to offer better care at home for their babies.
Dream Sock will also show oxygen saturation level and pulse rate. If an infant’s measurements are outside of predetermined ranges, the solution will notify caregivers with lights and an alarm.
The US-based Owlet intends to make the new medical-grade features available to all current and prospective Dream Sock users upon its launch, which is expected to be announced soon.
These approved features can be used with healthy babies weighing between six and 30 pounds and between one and 18 months, the parenting platform solutions provider said.
Owlet CEO and co-founder Kurt Workman said: “Today marks a significant breakthrough in our journey to bring care to the home and empower parents with an unprecedented FDA-clearance for the Owlet Dream Sock.
“This accomplishment not only signifies our commitment to innovation in the infant health category but, more importantly, our dedication to ensuring the health and well-being of every baby.
“With this De Novo clearance, we are proud to set new standards in at-home infant care, arming parents with reliable real-time information and providing enhanced peace of mind.”
The Owlet Dream Sock was clinically tested in both home and hospital settings before receiving the FDA’s De Novo clearance.
Owlet said that several independent laboratories have verified that the oximeter complied with all applicable performance and safety standards and was as accurate as medical-grade infant monitoring equipment.
The technology can allow caregivers to have access to the right information at the right moment, boosting their confidence and clarity regarding the child’s wellbeing, as per the digital health technology firm.
The clearance follows the previous approval by the FDA of the company’s BabySat prescription monitoring device, which has a modern, wire-free sock design and pulse oximetry technology.
