The SNOO Smart Sleeper Receives FDA Approval

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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.

—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. “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.

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 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.

 

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