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# De Novo Granted to Sleeping Infant Device
- URL: https://www.fdaweb.com/de-novo-granted-to-sleeping-infant-device/
- Published: 2023-04-03T12:00:00.000Z
- Updated: 2026-09-14T18:23:22.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5154121

FDA has granted a de novo marketing authorization to Happiest Baby for its SNOO, a medical device for keeping sleeping babies safely on their backs. “The SNOO Smart Sleeper bassinet plus the SNOO Sleep Sack are jointly intended to facilitate a supine position during sleep,” the company says. Infants who are placed in such a position are at a lower risk of sudden death, the company says, adding that it is intended for home use by caregivers of infants under six months of age who are not yet able to roll over consistently.