FDA grants, medical device clearance to Snoo robotic baby bassinet

Already popular with the parents of newborns, the makers of the Snoo motorized bassinet hope it will become the favored choice among hospitals and, perhaps one day, insurance providers.  Happiest Baby — the company co-founded and led by Harvey Karp, author of the Happiest Baby on the Block series of parenting books — has received a de novo clearance from the FDA, marking the Agency’s first official green light for what it describes in regulator-ese as an over-the-counter “infant supine sleep system.”

Equipped with white noise machines and motors to gently rock and calm the baby, the Snoo responds automatically to cries and fussing by slowly dialing up the motion and sounds when needed — acting as an extra pair of hands for the sleep-seeking set.

The $1,700 retail bassinet is paired with a zip-up sleeping sack that clips onto the flat mattress.  This holds the baby on their back as they sleep, and keeps them from rolling over onto their belly during the night.  Meanwhile, a smartphone app logs the time spent sleeping in its different soothing modes.

The design was inspired by ways to avoid cases of sudden infant death syndrome, or SIDS, where many newborns are found on their stomach.  The company estimates that more than 3,500 SIDS fatalities occur annually.  Organizations including the American Academy of Pediatrics have recommended that infants only sleep on their back on a firm, flat surface.  However, the company will not be able to advertise the device as a solution just yet.  While sleeping on the back has been shown to lessen the risk of SIDS or sudden unexpected infant death, the FDA said its comparison of Snoo study data to historical statistics collected by the CDC was not sufficient enough to demonstrate a strong reduction.  “Therefore, the device is not intended to prevent or reduce the risk of SIDS/SUID,” the FDA noted in an announcement in early April 2023.  However, at the same time, the data did not show an increased risk, the Agency said.  “At this time, there are no infant sleep systems or infant positioners authorized for marketing by the FDA to prevent or reduce the risk of SIDS/SUID.”

Outside of the home, versions of the Snoo have been used in hospital nurseries, NICUs and medical centers focused on babies withdrawing from opioids, according to a report from the Financial Times.  These come equipped with wheeled platforms and waterproof reusable and disposable covers.

The Snoo previously received a breakthrough device designation from the FDA in 2020, granting extra feedback from Agency officials and prioritized review.  At the time, Happiest Baby said: “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.”

REFERENCE:  Fierce BioTech; 03 ARP 2023; Conor Hale