
Owlet Receives FDA Approval For Non-Prescription Dream Sock Significantly Expanding Market
11-9-23 (by Scott Gleason) Owlet has received approval from the U.S. Food and Drug Administration (FDA) for its Dream Sock. The announcement establishes Dream Sock as the first over-the-counter medical pulse oximetry solution for infants, paving the way for advanced digital health technologies in at-home infant care. Dream Sock is designed to monitor and display a baby’s Live Health Readings, encompassing pulse rate and oxygen saturation levels. It goes beyond conventional monitoring by providing Health Notifications, alerting caregivers with lights and alarm sounds if their infant’s readings fall outside preset ranges. These medical-grade features are aimed at healthy infants aged 1-18 months, weighing between 6 lbs to 30 lbs. The newly FDA-cleared features will be rolled out to existing and new Dream Sock users in the U.S. by the end of the year.
This achievement follows Owlet’s prior FDA clearance for BabySat in June, a prescription monitoring system utilizing pulse oximetry technology, intended for infants with acute or chronic medical conditions. The new device will not require a physician prescription. Owlet had previously pulled the Dream Sock from the market following an FDA warning letter stating that it was a device.
Kurt Workman, Owlet’s CEO and Co-Founder, expressed the significance of this achievement, emphasizing the company’s dedication to innovation in infant health. The De Novo clearance signifies a commitment to setting new standards in at-home infant care, equipping parents with reliable real-time information and enhancing peace of mind.