FDA Clears Robotic Bassinet as Medical Device

Happiest Baby’s Snoo robotic bassinet was granted medical device approval by the US Food and Drug Administration (FDA). Snoo rocks infants with a built-in motor system and helps soothe babies with calming sounds, all while keeping them on their back. The device is intended to reduce sudden infant death syndrome (SIDS), which kills over 3,500 infants in the US each year.

According to , “However, the company won’t be able to advertise the device as a solution just yet. While sleeping on the back has been shown to lessen the risk of SIDS or sudden unexpected infant death, the FDA said its comparison of Snoo study data to historical statistics collected by the CDC was not sufficient enough to demonstrate a strong reduction.”

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(Source: Fierce Biotech, April 3^rd, 2023)