Owlet announces fda software-as-a-medical device submission for heart rate and oxygen displays and notifications

Lehi, utah--( business wire )--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.” designed for parents and caregivers to monitor healthy babies at home, the health notifications software would provide displays of live heart rate and oxygen saturation for babies, in addition to the opportunistic notifications when these readings move beyond certain ranges.
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