Last week I talked about the distinctions between traditional medical devices and an emerging category called wellness devices.
The Owlet baby monitor is an example of a wellness device that has potential to have a huge and life-saving impact. Per FDA's draft guidance document as discussed in that last post, Owlet doesn't (yet) claim to do anything except help you monitor whether or not your sleeping infant is breathing: they'll keep watch so you can sleep, too. Of course, this is pretty useful in itself. It takes existing technology (a pulse oximeter, like you might have seen in a hospital) and brings it into the home, paired with a simple alert device, and accessibility via your phone. Take a look:
So again, this is currently a wellness device, meaning that it isn't - and can't be - claiming to treat, cure, or mitigate any disease (read their disclaimer here). They've submitted an application to FDA and upon clearance the Owlet will then transition to being a medical device. Their disclaimer points out that this "device is not intended to cure, treat, or prevent...Sudden Infant Death Syndrome (SIDS)." That said, a benefit of this becoming a medical device (and therefore reimbursable by health insurance companies) seems to be an obvious and wise move for Owlet.
SIDS is a type of SUID (Sudden Unexpected Infant Death). Per the CDC, "SIDS is defined as the sudden death of an infant less than 1 year of age that cannot be explained after a thorough investigation is conducted, including a complete autopsy, examination of the death scene, and a review of the clinical history. About 1,500 infants died of SIDS in 2014. SIDS is the leading cause of death in infants 1 to 12 months old. ...Even after a thorough investigation, it is hard to tell SIDS apart from other sleep-related infant deaths such as overlay or suffocation in soft bedding."
All of which is to say: If your baby isn't breathing in the middle of the night, Owlet is intended to alert you so that you can intervene. Watch more stories below.
These parents lost a child to SIDS. They later had another child and beta-tested the Owlet, with the motivation of their previous loss. Note that Owlet is not claiming to resolve SIDS. The emphasis is on Owlet being on duty when parents can't be. "The Owlet doesn't ever sleep, so you can."
This parent's child was born at two and half pounds, and was in the NICU for two months. "In the NICU she was always being watched over and had monitors, and we came home and it was very nerve-wracking to have a little tiny four pound baby at home." She goes on to talk about how the Owlet helped her intervene one night when her baby was silently choking, and the reassurance she feels in using it.