- Dr. Harvey Karp nearly announced last summer that the FDA certified that Snoo reduces SIDS.
- But FDA approval of the $1,700 high-tech crib never came — and month's later is still missing.
Dr. Harvey Karp was inspired to sketch the first prototype for the cult-favorite Snoo bassinet after giving a 2008 talk on sudden infant death syndrome, or SIDS, according to company lore. Every year, SIDS and other sleep-related deaths kill roughly 3,500 infants in the US, according to the American Academy of Pediatrics.
"If a foreign nation was killing 3,500 of our babies every year, we would probably declare war," Karp said, per a post on his company's website. "Why aren't we doing more to end this terrible situation?"
But 15 years later, the ability of the Snoo — now on the market as a $1,700 high-tech bassinet — to reduce SIDS remains unproven. Despite lofty promises from Karp and Nina Montée Karp, his wife and cofounder, experts who spoke with Insider remain skeptical.
Happiest Baby, the company behind the Snoo, has spent years seeking FDA certification, announcing in 2020 it had been "accepted" into the FDA's Breakthrough Devices Program, intended to fast-track approval. The company portrayed the acceptance as a major victory, with Karp tweeting in October 2021: "We're grateful SNOO is the first bed FDA has called a BREAKTHROUGH that might reduce SIDS!"
Experts say the reality is less straightforward. The Breakthrough Device Program has accepted 728 devices since it began in 2015, but only 56 have received FDA clearance. That means 92% of "breakthrough devices" — including the Snoo — are stuck in the pipeline or have been rejected by the agency.
"If you apply to go to Harvard, that doesn't mean that you are a Harvard student," said Dr. Rachel Moon, a professor of pediatrics and a SIDS researcher at the University of Virginia.
According to Moon — who coauthored the AAP's most recent recommendations on reducing SIDS — it would take a randomized study of millions of infants to prove that the Snoo reduces SIDS. Bradley Merrill Thompson, a lawyer specializing in FDA issues, told Insider that any device that has been under review for more than two years has hit significant roadblocks.
A press release about FDA certification that was never formally released
Happiest Baby seems to have hit one such roadblock this past summer when the company sent out an embargoed press release — since viewed by Insider — to select journalists.
The press release, labeled "Under Strict Embargo Upon FDA Announcement" but with publishing set for some point in July 2022, announced that in "a momentous advance, the FDA has granted Happiest Baby's de novo classification request, making SNOO Smart Sleeper the first medical device proven to reduce SIDS."
"As a pediatrician for over 40 years, I have seen the terrible grief of parents who woke in the morning only to find their tiny baby blue and lifeless," said Dr. Karp in the press release. Karp said he and his wife created the Snoo to reduce parent stress and reduce SIDS. "Now, after a decade of scientific efforts, our team is honored that SNOO is the first device authorized by the FDA for reduction of SIDS and SUID. Saving a single life is a cause for celebration and having the potential to save hundreds or thousands of lives is a dream come true."
But the FDA approval never came, and the press release was never officially distributed.
Eight months later, the FDA still hasn't approved the Snoo as a medical device, according to public records. The FDA told Insider it couldn't discuss applicants to the Breakthrough Device Program, including if they're still involved in the program.
Dr. Colleen Kraft, a professor of pediatrics at Keck School of Medicine at the University of Southern California and Happiest Baby's vice president of medical affairs, said the company "has never claimed to reduce SIDS."
"Rather, it has consistently stated that SNOO is specifically designed to keep sleeping babies safely on their back," Kraft said in a statement to Insider. A study conducted by Karp found only that Snoo reduces self-reported behavior linked to SIDS, such as babies not sleeping on their backs, as opposed to reducing SIDS-related deaths.
A troubled company with a hit product
The Snoo's SIDS-prevention potential is just one of many controversies plaguing the bassinet.
More than a dozen former and one current employee told Insider that Karp and Montée Karp run Happiest Baby as a "surveillance state," spying on employees and botching the development of the next-generation Snoo. (A Happiest Baby representative called employees' concerns "factually inaccurate," saying "we greatly respect the rights of our employees and carefully follow all applicable laws and regulations.")
While some studies seem to indicate that the Snoo can encourage infants to sleep longer, experts told Insider it could create other issues, such as babies struggling to transition away from the crib. And the $1,700 price tag raised concerns amongst some who spoke with Insider.
If Karp and Montée Karp "really want to save 3,500 babies a year that died from SIDS" and other sleep-related deaths, Moon said, "the vast majority of them are socioeconomically not going to be able to afford the Snoo."