Tag: Owlet

Owlet Announces FDA-Clearance of the First Prescription Pulse Oximetry Sock for Infants

LEHI, Utah–(BUSINESS WIRE)–Owlet (NYSE: OWLT, “the Company”), the pioneer of smart baby monitoring, announces clearance from the U.S. Food and Drug Administration (“FDA”) of BabySat™, the first medical pulse-oximetry device featuring its advanced, wire-free sock design. Owlet is a leader in infant […]

Owlet Announces FDA Software-as-a-Medical Device Submission for Heart Rate and Oxygen Displays and Notifications

Owlet submitted a de novo classification request to the FDA for an over-the-counter software-as-a-medical-device that offers heart rate and oxygen displays and notifications in conjunction with Owlet’s existing Dream Sock sleep monitoring capabilities. December 22, 2022 04:05 PM Eastern Standard Time LEHI, Utah–(BUSINESS […]

Owlet’s Data Identifies Previously Undetected Increased Prevalence of Cardiac Arrhythmia in Young Infants in Study Published in The Journal of Pediatrics

Owlet algorithms detect tachyarrhythmia among infants at higher incidence than previously reported in studies relying on clinical diagnosis LEHI, Utah–(BUSINESS WIRE)–Owlet Baby Care Inc. announced today that a third-party study using data collected by its flagship product, the Owlet Smart Sock, […]