Medical Device by FDA

A cot for babies, known as the SNOO Smart Sleeper Cot, has received FDA clearance to be classified as a Class II medical device. Happiest Baby, located in Los Angeles, claims that this is the first instance in which the FDA has granted De Novo clearance to a device intended to keep sleeping infants on their backs.

Sudden Infant Death Syndrome (SIDS) is a prominent factor in infant deaths. The NHS in England and the American Academy of Pediatrics recommend putting sleeping infants on their backs to help prevent SIDS. The infant is swaddled and put to bed by the SNOO smart cot, which makes it easier for them to sleep on their backs (supine).

The Snoo responds automatically to cries and fussing by gradually turning up the motion and noises as needed and acting as an additional pair of hands for the sleep-seeking set. It is equipped with white noise makers and motors to keep the infant quiet.

The CEO of Happiest Baby, Dr. Harvey Karp, released a statement: “Stomach sleeping leads to the tragic death of thousands of healthy infants every year. Yet, we routinely put babies in bed 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.”

A sleeping bag with a zip-up closure that snaps onto the flat mattress is included with the $1,700 retail bassinet. This protects the baby from rolling onto their tummy as they sleep and keeps them on their back. A smartphone app records the amount of time spent sleeping while using its various calming modes.

Events of sudden infant death syndrome, or SIDS, when many babies are discovered on their stomachs, served as inspiration for the design. According to the firm, there are more than 3,500 SIDS fatalities per year. Infants should only sleep on their backs on a hard, flat surface, according to recommendations made by groups like the American Academy of Pediatrics.

The business won’t be allowed to promote the product as a solution to SIDS. However, studies have indicated that resting on one’s back reduces the incidence of SIDS or sudden unexpected infant death. The FDA said that their comparison of Snoo study data to earlier figures gathered by the CDC was insufficient to establish a significant decrease.

The FDA believes that the gadget is not designed to prevent the risk of SIDS/SUID. But, the government also noted that the data did not indicate an elevated risk. At this time, the FDA has not approved the sale of any newborn sleep systems or infant positioners to prevent or lower the risk of SIDS/SUID.

The FDA previously designated the Snoo as a breakthrough device in 2020, offering it more government input and expedited assessment. Happiest Baby believes that more employers, governmental organizations, and insurance companies will pay the cost if Snoo achieves FDA certification.

Also, read; PTSD Neuromodulation Device Cleared by FDA

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