The Cult-Favorite SNOO Smart Sleeper Receives FDA Approval

The smart bassinet has officially become the first and only medical device to receive De Novo classification from the FDA for its ability to keep sleeping babies safely on their backs.
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By Wyndi Kappes, Associate Editor
Published April 3, 2023
snoo gets FDA approval
Image: Happiest Baby

The SNOO has officially become the first and only medical device to receive De Novo classification from the Food and Drug Administration (FDA) for its ability to keep sleeping babies safely on their backs. The smart sleeper—a 2022 Best of Baby Award winner—touts a built-in swaddle that zips into the bassinet to secure wriggly babies, preventing unsafe rolling and keeping them safely asleep on their backs.

“As a pediatrician for over 40 years, I’ve witnessed far too many times the unbearable pain of parents whose placed their baby in bed at night…only to find them lifeless in the morning,” Harvey Karp, MD, co-founder and CEO of Happiest Baby, Inc. said in a press release. “Stomach sleeping leads to the tragic death of thousands of healthy infants every year. Yet, we routinely put babies in bed—totally unsecured—for 12-14 hours every day. Just as infant seats dramatically improve car safety, we hope to dramatically improve sleep safety by keeping babies on the back and reducing risky rolling.”

Outside of advanced safety features, the SNOO is praised for its high-tech integrations that can help soothe baby to sleep. The smart bassinet uses constant womb-like rocking and white nose to help baby fall asleep and stay snoozing. It also automatically responds to baby’s fussing and helps baby develop healthy sleep habits from the start without the need for constant motion.

The FDA notes that the SNOO is indicated only for use in infants from birth to 6 months of age or until babies can roll over consistently. In a study of 1,012 infants, SNOO was found to reduce unsafe stomach sleeping by 91.5 percent but has not directly demonstrated a reduction in the incidence of sudden infant death syndrome (SIDS). The American Academy of Pediatrics (AAP) remains resolute in its advice that back sleeping, on a flat, bare surface, remains the best way to ensure a safe sleep environment for baby.

For parents interested in trying out a SNOO smart sleeper, Happiest Baby is currently offering 20 percent off bundles. You can also rent the sleeper at a more affordable price and schedule delivery based on their due date at

Please note: The Bump and the materials and information it contains are not intended to, and do not constitute, medical or other health advice or diagnosis and should not be used as such. You should always consult with a qualified physician or health professional about your specific circumstances.

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