How the Owlet smart sock went from a parent favorite to an FDA warning

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

“How difficult it was to have him,” Askew explained, “we wanted to make sure we had peace of mind.”

“And then when we found out that maybe the FDA was asking Owlet to take this off the market, we went ahead and bought two more for our twins along the way. “

Many other parents are also fans of the smart sock. On Tuesday, 144,000 people signed an online petition to keep the sock in the US market.

They began to lend their names after Owlet announced on November 24 that he would stop selling the sock. This followed years of correspondence with the United States Food and Drug Administration.

The smart sock monitors babies’ heart rate and oxygen levels and feeds the data to a phone app, all at a cost of around $ 300.

Kurt Workman co-founded Owlet in 2012 while 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 explained, “were concerned that our children had a congenital heart defect that she had.”

“I remember asking myself as we were starting our family, ‘How would I know if something was wrong? “”

While the sock has been a hit with many parents, Owlet has had issues with the FDA.

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

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

He again informed Owlet that the smart sock meets the definition of a regulated device and the company still has not received marketing authorization. The letter asked Owlet to stop selling the sock.

Owlet refused FOX 13 interview requests. His Nov. 24 statement announcing the halt to sales of smart socks in the United States indicated that they would still be sold in foreign countries.

“It is probably a medical device. It’s been used in a medical setting for sure, ”said Jeff Whitlock, a technology entrepreneur from Utah.

Whitlock’s wife worked at Owlet and still owns shares in the company. The couple also placed the smart sock on their own children.

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

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

“Let me put it that way,” said Whitlock, “I think it would be very unlikely that if Owlet had gone through the traditional IPO process through a big bank that, for example, would have hit the markets audiences with that kind of risk. “

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

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

“I’m concerned that this increases anxiety rather than decreasing it for, I guess, more families than it helps,” said Ellie Brownstein, president-elect of the Utah chapter of the American Academy of Pediatrics. .

She discouraged parents from using the sock.

“My biggest concern is that I think it gives them a false sense of security that it can help prevent SIDS or Sudden Infant Death Syndrome,” said Brownstein, “and studies have shown that apnea monitors were not good for it. “

Brownstein said she has also seen families see a doctor for what turned out to be false readings, which Owlet acknowledged on his website can happen for reasons that include a poor fit of the baby’s foot. Unnecessary visits can drive up medical bills and expose parents and children to illnesses in the hospital or clinic.

Askew, from Richmond, Va., Said she didn’t view the sock as a medical device – just a tool.

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

“I would probably go see him every two minutes,” she laughed. “It would mostly be my husband right now.”

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