Owlet has received de novo clearance from the US Food and Drug Administration (FDA) for its over-the-counter medical pulse oximetry solution, Dream Sock, for infants.
Claimed to be the first and only of its kind, the Dream Sock will be used for monitoring and showing the baby’s live health readings, including pulse rate and oxygen saturation level.
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It will also offer health notifications, alerting caregivers through lights and alarms when the infant’s readings go beyond preset ranges.
Owlet intends to offer the new medical-grade features to both existing and new Dream Sock users before the year’s end.
These approved features are intended for healthy infants aged 1-18 months and weighing between 6lb and 30lb.
The Dream Sock underwent clinical testing in home and hospital settings, demonstrating its accuracy with medical-grade baby monitoring technology.
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By GlobalDataIt is also claimed to comply with all relevant performance and safety standards, as verified by independent laboratories.
“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,” said Owlet CEO and co-founder Kurt Workman.
“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.”
