SNOO Accepted to FDA's Breakthrough Device Program, Will Undergo Fast-Track Review for Final Approval
For SNOO parents, every night of better and better sleep can feel like a little breakthrough, all on its own. Now, SNOO wants to crown those tiny successes with a truly monumental breakthrough.
We are thrilled to share that the Food and Drug Administration (FDA) has accepted SNOO Smart Sleeper into its Breakthrough Device Program. This program was created to speed the FDA’s usually meticulous and in-depth review of medical products so that life-saving devices can be made available to consumers much more quickly.
SNOO Smart Sleeper was designed specifically to keep babies safely on the back all night and for all naps. And the FDA is evaluating SNOO’s potential to prevent the terrible tragedy of infant sleep death (SIDS/SUID).
Approximately 3,600 U.S. babies have died in their sleep every year since 1999. Sadly, little progress has been made in reducing this alarming number of infant sleep fatalities in over 20 years. Almost 50% of babies who die in their sleep are found on the stomach, a position reported to raise the risk of SIDS/SUID by 300 to 400%. It’s for this reason that the American Academy of Pediatrics and National Institute of Health strongly recommend that babies only sleep on their backs.
Although there is an urgent need to prevent these deaths, SNOO is the first device ever presented to the FDA that the Agency feels may be able to demonstrate a clear reduction in SIDS/SUID.
To date, babies have logged over 135,000,000 hours of safer sleep in their SNOOs. This is a very hopeful advance, especially in light of the recent recalls of inclined sleepers after the Consumer Product Safety Commission received the very disturbing reports of 73 infant deaths.
Families across America can now rent SNOOs for about the cost of a cappuccino. Dozens of top corporations now offer rented SNOOs as a support for their new families. We hope that—if SNOO receives FDA approval— even more employers, governmental agencies, and insurance companies will cover the cost so that many more parents will be able to experience the safety and peace of mind that SNOO can bring to them.
Happiest Baby looks forward to working with the FDA. We are hopeful that we are now at a wonderful moment in medicine when we will finally be able to take a huge step towards reducing the suffering and loss caused by these needless deaths!
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Disclaimer: The information on our site is NOT medical advice for any specific person or condition. It is only meant as general information. If you have any medical questions and concerns about your child or yourself, please contact your health provider.