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Owlet puts smart baby monitoring socks on hold after FDA warning

Owlet puts smart baby monitoring socks on hold after FDA warning

Owlet has stopped selling its lineup of smart baby monitoring socks, which are believed to track a baby's vital signs and sleep patterns, after receiving a warning letter from the Food and Drug Administration (FDA) . First reported by Deseret News, the FDA's letter states that Owlet's smart socks are considered medical devices, because they provide heart rate and oxygen level information, and the company gives them the appropriate "marketing approval." Is. Is. "Without approval, or without authorization". FDA.

Owlet has since pulled its family of smart socks, as well as any bundles that include the device from its site. The Smart Socks product page reads, "The Ovlet sock family of products is currently unavailable." "Check back in the coming weeks to see the latest additions to the nest." Owlette Smart Socks are still available on other online marketplaces, such as Bed Bath & Beyond, Amazon and BuyBaby -- at least for the time being. The Owlette Smart Socks will still be available for purchase outside the US.

The FDA states that Smart Socks are medical devices, specifically because their purpose is to measure blood oxygen saturation and heart rate "to identify (diagnose) decompensation and bradycardia, and to provide an alarm to inform users that the measurement was previously performed." As mentioned in the letter, Owlette has previously stated that its smart socks are low-risk products, not medical devices. The FDA has been explicitly informing the brand that this is not the case since 2016.

Owlet posted a response on its site to the FDA, noting that it plans to comply with the FDA's request, and will seek marketing approval for its features that track heart rate and blood oxygen levels. Is. Is. Is. The company also says that the FDA "did not identify any safety concerns with respect to the smart sock" and reassures existing sock owners that there has been "no change" to its functionality.

Owlet hinted at introducing a new, similar product in its letter, saying it plans to introduce "a new sleep monitoring solution" that will be available "soon." The Verge contacted Owlette about its upcoming product and whether it will replace the Smart Sock, but didn't immediately hear back.

Smart baby monitors like Owlet's Smart Socks have been criticized in the past. Doctors have suggested that they may actually put children at risk, due to the fact that they are not classified as medical devices, and are not subject to certain regulations and oversight.

“The security of the Smart Sock has been validated by a third party, in which it was shown to be secure,” Owlett emphasized in his post. “In addition, we did not identify any safety concerns regarding the Smart Sock in the letter we received from the agency [FDA].”

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