On April 3, 2023, Happiest Baby announced the FDA granted De Novo approval to its SNOO Smart Sleeper, which keeps sleeping babies safely positioned on their back and uses continuous rhythmic sensations that mimic the experience of being in the womb.
About the SNOO Smart Sleeper
The SNOO Smart Sleeper bassinet and SNOO Sleep Sack are jointly intended to facilitate a supine position during sleep.
The SNOO bassinet provides a gentle shushing and rocking by safely moving the baby back and forth in the horizontal plane. It detects the infant’s cries and automatically responds with gradually increasing white noise and motion.
The SNOO Sleep Sack is a cotton swaddle with fixed wings that extend to the right and left of the infant’s body. A narrow, tubular elastic loop at the end of each wing is slid onto the safety clip, thereby securing the infant — swaddled in the sleep sack — on the back during sleep.
SNOO is intended for home use by caregivers of infants from birth to six months of age, who are not yet able to roll over consistently.
While SNOO is demonstrated to facilitate a supine position during sleep, it has not directly demonstrated a reduction in the incidence of sudden infant death syndrome (SIDS) or sudden unexpected infant death (SUID).
According to the company’s press release, this is the first time the FDA has granted De Novo approval to a product designed to keep sleeping babies safely positioned on the back.
About safe infant sleep
The American Academy of Pediatrics recommends that infants should only sleep on the back for the first year of life. The National Institutes of Health encourages back sleeping to lower an infant’s risk of SIDS, and the CDC advises that babies who sleep on their backs are less likely to die of SIDS than those who sleep on their sides or stomachs.
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