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FOX 13 Investigates: How Owlet smart sock went from a parent favorite to an FDA warning

Posted at 10:46 PM, Dec 07, 2021
and last updated 2021-12-08 00:54:32-05

SALT LAKE CITY — Krystina Askew bought an Owlet smart sock for her first son, who was conceived through fertility treatments.

“Just how hard it was to have him,” Askew explained, “we wanted to make sure we had the peace of mind.”

“And then when we found out that the FDA was possibly telling Owlet to pull this from market, we went ahead and bought two more for our twin boys on the way.”

Lots of other parents are fans of the smart sock, too. As of Tuesday, 144,000 people signed an online petition seeking to keep the sock on the U.S. market.

They started lending their names after Owlet announced on Nov. 24 that it would stop selling the sock. That followed years of correspondence with the U.S. Food and Drug Administration.

The smart sock monitors babies' heart rates and oxygen levels and transmits the data to a phone app — all for a cost of about $300.

Kurt Workman co-founded Owlet in 2012 when he was studying chemical engineering at Brigham Young University. The company is headquartered in Lehi, Utah.

“So, I’m a dad. I have three children,” Workman explained in an interview earlier this year with WFT Health.

“My wife and I,” he went on to explain, “were concerned that our kids would have a congenital heart defect that she’s had.”

“I remember wondering as we were starting our family, ‘How would I know if something were wrong?’”

While the sock has been a hit with many parents, Owlet had some things go wrong with the FDA.

FOX 13 obtained a report through the Freedom of Information Act showing that in 2017, the FDA concluded that Owlet’s sock was a medical device that needed FDA marketing approvals. The company for years has sold the sock with a disclaimer that it still needed approval from the FDA.

Owlet began trading on the New York Stock Exchange in July of this year. Then, on Oct. 5, the FDA sent the company what was labeled as a “warning letter.”

It again notified Owlet that the smart sock fit the definition of a regulated device and that the company still had not received marketing clearance. The letter asked Owlet to stop selling the sock.

Owlet declined interview requests from FOX 13. Its Nov. 24 statement announcing it was halting U.S. smart sock sales pointed out it would still be sold in foreign countries.

“It probably is a medical device. It was used in a medical context for sure,” said Jeff Whitlock, a Utah tech entrepreneur.

Whitlock’s wife used to work at Owlet and still owns shares of the company. The couple also has placed the smart sock on their own children.

“So, my point of view is not necessarily that the FDA is wrong,” Whitlock said. “It’s just that [the sock has] been on the market for so long, why not work with the company to get required approvals?”

Owlet went public with the help of one investment firm. Whitlock suspects that if Owlet used the traditional route of finding multiple Wall Street financiers, those financiers might have performed more due diligence on Owlet’s standing with the FDA.

“Let me put it this way,” Whitlock said, “I think it would be very unlikely that if Owlet had gone through the traditional IPO process through a major bank that, like, they would have hit the public markets with this sort of risk.”

Neither the investors behind the company nor the FDA returned messages seeking comment.

Some pediatricians have had their own concerns about the smart sock.

“I worry that it increases anxiety rather than decreases anxiety for, I suspect, more families than it helps,” said Ellie Brownstein, the president-elect of the Utah Chapter of the American Academy of Pediatrics.

She has discouraged parents from using the sock.

“My biggest concern is I think it gives them a false sense of security that it can help prevent SIDS or sudden infant death,” Brownstein said, “and studies have shown that apnea monitors have not been good at doing that.”

Brownstein said she’s also seen families go to a doctor for what turned out to be false readings, something Owlet on its website has acknowledged can happen for reasons that include a poor fit on the baby’s foot. The unneeded visits can run up medical bills and expose parents and children to diseases in the hospital or clinic.

Askew, of Richmond, Virginia, said she doesn’t regard the sock as a medical device — just a tool.

How would Askew raise her 1-year-old son without the smart sock?

“I’d probably go in and check on him every couple of minutes,” she laughed. “Mostly that would be my husband right now.”

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