Hey guys, so sorry it's been so long! I'm not going to lie I got a little discouraged when the petition stalled a bit and there didn't seem to be any forward movement with the FDA for Owlet. I'm excited to say I've been in close contact with Owlet directly and our voices are making a difference!! I have a couple of updates to share and I also ask that you continue to share the petition everywhere that you can. It seems like we are in the home stretch but we need just a little more motivation and we need to be able to show the FDA how much this product means to parents and babies. Thank you all so much for your support I absolutely could not have made it even this far without all of you.

Updates to follow:

In October 2022, Owlet announced the FDA submission for a prescription-only monitor designed to be used in-home for babies under the supervision of a physician. This device is intended to be prescribed by physicians for assisting with the in-home monitoring of babies under a physician’s care. The device provides alerts to parents when their baby’s heart rate or oxygen saturation level (SpO2) does not fall within prescribed ranges. 

In December 2022, Owlet submitted to the FDA a 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. 

Owlet continues to work closely with the FDA to get these clearances reviewed.