FDA accepts Owlet's de novo submission for Health Notifications SaMD for heart rate and oxygen

Owlet, Inc.

FDA accepted for substantive review Owlet's de novo classification request for over-the-counter SaMD 'Health Notifications'.
Health Notifications would provide live heart rate and oxygen saturation displays and notifications via Dream Sock.
This is Owlet's second FDA submission in 2022; first was a 510(k) for a prescription monitor in October.
CEO Kurt Workman stated FDA authorization could uniquely position Owlet to help caregivers with live health data.
De novo pathway is for low-to-moderate risk devices with no legally marketed predicate.

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