Following receipt of a warning letter from the U.S. Food and Drug Administration, Utah-based tech startup Owlet, innovators of a baby sock that monitors infant vital signs, will stop selling the product until it earns approval from the federal agency.

The company reports it has sold over 1 million of the monitoring socks since it launched in 2015 and says it will continue to offer support for those who have already purchased the product. While the FDA did not cite any safety concerns, and is not asking for the product to be recalled, Owlet said it has halted sales of the monitors pending FDA approval.

“Owlet received a Warning Letter from the FDA regarding the Smart Sock’s regulatory status in the United States,” an unsigned post to the Owlet website reads. “The letter we received from the agency did not identify any safety concerns about the Smart Sock; rather, the FDA asserts that the Smart Sock should be classified as a medical device in the U.S. because of the heart rate and oxygen notifications. Based on the FDA’s recent letter, Owlet plans to pursue marketing authorization from the FDA for these features.”

Owlet’s infant sock monitors vital signs like oxygen levels and heart rate and transmits the information, and warnings if data moves into unsafe levels, to a smartphone app. While the product is off the shelves for now, the company said it has another monitoring product coming online soon.

“As a result of the letter and in light of our plans to submit a device application to the FDA, we will no longer be selling the Smart Sock,” the web posting reads. “We plan to offer a new sleep monitoring solution, which we believe will be available soon. We also plan to continue to support our current customers. There has not been any change to your product’s functionality or a request from the FDA to exchange or return your product at this time. We will notify customers of any updates to the Smart Sock products that have already been distributed. This action is specific to the U.S. only and no other countries or regions are affected by this.”

Owlet has attracted nearly $180 million in venture backing since the company was founded six years ago, according to business data aggregator Crunchbase, and has grown its products beyond the monitoring sock to include other baby-centric products including monitoring cameras, sleep software and clothing.

In a 2017 Deseret News profile, Owlet co-founder and CEO Kurt Blackman talked about the trauma his wife experienced as an infant with a congenital heart defect, an experience that inspired the idea that would become the sock monitor.

Owlet co-founder Kurt Workman poses for a portrait at the Owlet headquarters in Lehi on Monday, May 1, 2017. | Alex Goodlett, Deseret News

“Ten days after my wife’s parents brought her home from the hospital, they rushed her back for emergency heart surgery,” Workman said.

She went on to have two additional cardiac operations.

During a visit to his wife’s cardiologist several years before the company would launch, to see if pregnancy would be a safe option, Workman’s thoughts turned back to what she went through as a child, and what they could do to keep their future baby safe.

“There was a chance our child could have the same defect, and I was worried about that,” he said. “How would I know if something was wrong?”

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Rather than wait for the answer, Workman took it upon himself to come up with a solution. He consulted with a friend, a nurse at University Hospital. Together they began working on a method to adapt pulse oximetry technology — that thing surgeons attach to the end of your finger to monitor oxygen levels — to be wireless and effective for an infant.

While the company has continued to grow and attract tens of millions in investment since its debut, notes of concern about the device are not new.

In January 2017, the Journal of the American Medical Association published an editorial on digitally connected infant monitors with a decidedly cautionary tone. The article noted that “there are no medical indications for monitoring healthy infants at home,” and monitors like the one Owlet makes, which are not subject to Food and Drug Administration approval, lack “publicly available evidence supporting the safety, accuracy, effectiveness or role of these monitors in the care of well infants.”

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The piece does go on, however, to note that “the current market of smartphone apps integrated with sensors that monitor infants’ vital signs are innovative and have potential to improve care.”

Pushing the envelope of the established regulatory realm has become a hallmark of new technology companies, and some of those conflicts, raised by companies such as Uber, Lyft and Airbnb, have played out in very public settings.

The article’s authors even reference what may be construed as a disconnect needing to be addressed between the current process and technological advances that may be outpacing it.

“Striking a balance between fostering innovation while providing appropriate and efficient regulation in the rapidly expanding mobile medical app market is challenging,” the article stated.

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