FDA Accepts De Novo Submission to Expand Use of Owlet’s Dream Sock

The FDA has accepted for review Owlet’s De Novo classification request to expand the functions of the company’s Dream Sock to include heart rate and oxygen levels.

The Dream Sock is a monitor that wraps around the baby’s foot. The De Novo request is for accompanying software that the company calls Health Notifications, designed to provide displays of live heart rate and oxygen saturation, as well as notifications when the readings move beyond certain ranges.

The De Novo authorization pathway is an option for applicants with novel medical devices considered reasonably safe and effective with certain controls but have no legally marketed predicate device.