The US Food and Drug Administration (FDA) has given approval for the SNOO Smart Sleeper Cot as a Class II medical device. According to Los Angeles-US based Happiest Baby, this is the first time the FDA has given De Novo approval to a product designed to keep sleeping babies on the back.
Sudden Infant Death Syndrome (SIDS) is a leading cause of death of babies. One of the ways to reduce SIDS is to place sleeping babies on their back, according to the NHS in England and American Academy of Pediatrics.
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The SNOO smart cot facilitates back (supine) sleeping by swaddling the baby and attaching them to the bed.
“Stomach sleeping leads to the tragic death of thousands of healthy infants every year. Yet, we routinely put babies in bed totally unsecured for 12 to 14 hours every day. Just as infant seats dramatically improve car safety, we hope to dramatically improve sleep safety by keeping babies on the back and reducing risky rolling,” said Dr. Harvey Karp, co-founder and CEO of Happiest Baby in a statement.
Since being designated onto the breakthrough device programme in 2020, the cot has generated a lot of buzz. However, there were also reservations from experts about the medical evidence backing the cot and its price tag which is nearly £1,200.
The new FDA authorisation marks a seal of approval for the company after a couple of years of regulatory limbo. Many corporations including JP Morgan, Activision-Blizzard and Snaphat already offer the cots to their workforce and could be joined by more companies aiming to take baby-care pressure off their employees. Healthcare providers might not be far too behind, either.
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By GlobalData
