November 27, 2021 05:51 pm
Original Link: https://www.theverge.com/2021/11/27/22804692/owlet-smart-baby-monitoring-socks-on-hold-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 supposed 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, as they provide heart rate and oxygen level notifications, and that the company has been selling them without the proper “marketing approval, clearance, or authorization” from the FDA.
Owlet has since pulled its family of Smart Socks, as well as any bundles that include the device from its site. “The Owlet Sock family of products is currently...
Original Link: https://www.theverge.com/2021/11/27/22804692/owlet-smart-baby-monitoring-socks-on-hold-fda-warning
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