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 health data, having monitored more than 1 million babies, and […]

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 WIRE)–Owlet, Inc. (NYSE: OWLT) (the “Company”) announces that the U.S. […]

Owlet Announces FDA 510(k) Submission for Prescription Pediatric Monitor

The Company filed a 510(k) premarket notification for its prescription-only medical device to be used in-home for babies under the supervision of a physician LEHI, Utah–(BUSINESS WIRE)–Owlet, Inc. (NYSE: OWLT) (the “Company”) announces that it has submitted a 510(k) premarket notification to the U.S. Food and Drug Administration (“FDA”) for […]

Owlet Adds Financial Experience to its Executive Team, Board of Directors

New CFO and Board Member will respectively lead the financial strategy and bring public company experience in the Company’s next chapter as it prepares to go public LEHI, Utah–(BUSINESS WIRE)–Owlet Baby Care Inc. (“Owlet” or the “Company”), the connected nursery ecosystem that delivers data-driven technology to modern parenting, is excited to […]

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, identified that abnormally high heart rates – a condition known […]