FDA Greenlights Smart Bassinet for Safe Infant Sleep

The Snoo Smart Sleeper is an advanced electronic bassinet designed for infants up to approximately six months old. It utilizes smart sensors to identify when a baby requires comforting and responds with automated rocking and white noise.

In March 2023, the U.S. Food and Drug Administration (FDA) granted De Novo approval for the Snoo, marketing it as an over-the-counter infant sleep system effective in maintaining back sleeping positions. However, in June 2026, the FDA issued a letter to parent company Happiest Baby, expressing concerns, including the introduction of new swaddle sizes.

Conceptualized by Dr. Harvey Karp, author of 'The Happiest Baby on the Block,' and engineered with MIT specialists and designer Yves Béhar, the Snoo was introduced in late 2016. Its design aims to address infant sleep deaths by providing a secure and soothing sleep environment, extending Dr. Karp's theory of the 'fourth trimester.'

While initially perceived as a niche, high-priced item, the Snoo has become more mainstream, with many parents willing to invest for improved sleep. Options like renting or purchasing used units are available to make it more accessible. The company asserts that the Snoo can increase infant sleep duration and aid in sleep training, though parent experiences vary.