Owlet receives FDA de novo clearance for Dream Sock as first OTC infant pulse oximeter

Owlet, Inc.

FDA-cleared Dream Sock monitors pulse rate and oxygen saturation for healthy infants 1-18 months, 6-30 lbs.
Device provides Health Notifications with lights and alarms when readings fall outside preset ranges.
Medical-grade features to roll out to existing and new Dream Sock users by end of 2023 (U.S. only).
Follows prior FDA clearance of prescription BabySat system; Dream Sock now available without prescription.
CEO calls it a 'significant breakthrough' in at-home infant care and commitment to innovation.

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