Owlet

5 articles about Owlet

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

  6/20/2023

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

  12/22/2022

  Owlet, Inc. (NYSE: OWLT) (the “Company”) announces that the U.S. Food and Drug Administration (“FDA”) has accepted for substantive review the Company’s de novo classification request seeking clearance to expand the functionality of Owlet’s Dream Sock’s existing sleep monitoring capabilities to include opportunistic heart rate and oxygen notifications, through software as a medical device that Owlet calls “Health Notifications.”

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  FDA Review: Alnylam, Cytokinetics, Eli Lilly and More

  10/7/2022

  The FDA had a fairly quiet week, approving drugs, providing clearance, greenlighting clinical trials, and other regulatory activities for Alnylam, Eli Lilly, Cytokinetics, and more.

• Owlet Release: Medical Device Company Submits For FDA Clearance On Owlet Smart Sock

  1/24/2017

• New York's Owlet Nabs $15 Million in New Funding

  11/10/2016