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About OwletThe Owlet Baby Monitor is a proactive health monitor for sleeping infants that allows parents to view their child's vital signs in real time. Owlet will alert the parent if there are low blood oxygen and heart rate levels giving parents peace of mind knowing that their baby is watched over.
January 23, 2013
Founder and CEO: Kurt Workman
Founder and COO: Jacob Colvin
Founder and CTO: Zack Bomsta
Founder and CMO: Jordan Monroe
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5 articles about Owlet
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
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.”
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.