Owlet’s New Sock Just Got Approved by the FDA

September 25, 2023

Remember the Owlet Smart Sock? The device would notify us parents and caregivers if our babies’ heart rates or oxygen levels were out of the normal range. While many parents reported the devices gave them peace of mind, Smart Socks were pulled from the shelves in 2021. This happened after violating the Federal Food, Drug, and Cosmetic Act. After completing FDA compliance however, Owlet’s New Sock Just Got Approved by the FDA.

Owlet’s New Sock Just Got Approved by the FDA – What’s BabySat?

The new wearable monitoring system is called BabySat. Here’s what parents of newborns and infants should know:

• Wireless – It’s the “first FDA-cleared pulse-oximetry medical device featuring Owlet’s modern and wire-free sock design.”
• Prescription – Available by prescription only. Prescriptions are for babies who may benefit from additional monitoring at home
• Physician Supervised – A physician sets the range of normal for pulse rate and oxygen saturation level. An alert sounds when your baby’s reading falls outside of these levels.

What About Safe Sleep Recommendations?

In the past doctor’s have cautioned against using wearable devices to monitor our babies’ vital signs. Medical grade devices are used in hospital NICU’s of course but home monitors were not recommended. In 2022 the American Academy of Pediatrics also amended Safe Sleep recommendations. These now include avoiding commercial devices that claim to reduce the risk of SIDS or other sleep-related deaths. AAP further states that the use of products claiming to increase sleep safety may provide a false sense of security and complacency for caregivers.

We asked Owlet about how BabySat fits into the 2022 guidelines and this is the response:

The AAP recommends avoiding the use of commercial devices that claim to reduce the risk of SIDS or other sleep-related deaths. BabySat is a prescription-only, medical pulse-oximeter device that is intended for babies that a healthcare provider determines could benefit from at-home monitoring while under the supervision of a physician. It is not intended to reduce the risk of SIDS or other sleep-related deaths, but will notify parents in real-time if their baby needs assistance and their pulse rate or oxygen saturation level falls too low or too high based on ranges set by their physician.

As always, decisions about your infant’s health should be made by you and your child’s primary care doctor.

Owlet’s New Sock Just Got Approved by the FDA – What About Other Sleep Items?

Parents as well as postpartum doulas, night nannies and nurses want facts when it comes to safe sleep. So you should know that any product intended or marketed for infant sleep must meet a federal safety standard. While BabySat has met this standard, it’s important to note that rockers, pillows, nappers and inclined sleepers have not. These items have been banned for sale and recalled. This is because the product’s incline enables infants’ heads to slump forward. This compresses the trachea and blocks airflow. This leads to lack of oxygen.

Whether parents choose to use BabySat or not, the safest way for your baby to sleep is alone, on a firm flat mattress without anything else in the crib. Postpartum doulas, night nurses or newborn caregivers can ensure your baby is sleeping safely as well.