Happiest Baby US
Happiest Baby US
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FDA Authorization

Is SNOO considered a medical device?

Yes. The FDA De Novo Authorization qualifies SNOO as a medical device in the United States. The De Novo classification means SNOO is a Class II medical device. For important safety information, please visit this page. Disclaimer: The information on o

Does the FDA’s De Novo classification mean that the SNOO could potentially be covered by insurance?

While SNOO is not currently covered by insurance, our ultimate goal is to have insurance cover SNOO for all families, so every baby gets a free SNOO Rental for the first 6 months of their life. But insurance coverage takes time (breast pumps weren’t

Does the FDA De Novo Authorization mean that SNOO might be covered as an employee benefit?

SNOO’s FDA De Novo Authorization certainly seems to have inspired more companies to offer SNOO as an employee benefit! Right now, thousands of new parents who work at companies like Under Armour and GoodRx already get a free 6-month SNOO Rental as a