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 […]
Tag: Owlet
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 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 […]
Owlet Reports Preliminary First Quarter 2021 Results
Preliminary Results Demonstrate Continued Strong Demand for Owlet’s Growing Connected Ecosystem Product and Service Suite Net revenues estimated to be $21.5M-$22.0M, a 45-48% increase from Q1 2020. Gross margin estimated to be 57-58%, a 1,000-1,100 basis point increase from Q1 […]
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 […]
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, […]