Oliver Berg is the picture alliance.
Owlet stopped selling its smart baby monitoring socks after receiving a warning letter from the FDA. According to the FDA letter, 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 proper approval.
The FDA did not identify any safety concerns about the Smart Sock.
Owlet pulled its family of Smart Socks and any bundles that included the device from its site. The Owlet Sock family of products is currently unavailable. The newest addition to the nest will be shown in the coming weeks. Owlet Smart Socks can be found on other online marketplaces, like Bed Bath & Beyond, Amazon, and Buy Buy Baby. Owlet Smart Socks can be purchased outside of the US.
The FDA says that the Smart Socks measure blood oxygen saturation and heart rate with the intent to identify desaturation and bradycardia and provide an alarm to notify users that they are outside preset values. Owlet previously stated that its Smart Socks are not medical devices. The FDA has told the brand that this isn't the case.
Owlet stated on its site that it will seek marketing approval for its features that track heart rate and blood oxygen levels, and that it will comply with the FDA's request. The FDA didn't identify any safety concerns about the Smart Sock, and the company reassured existing sock owners that there has not been any change to its function.
The Smart Sock was shown to be safe by third parties.
Owlet hints at introducing a new, similar product in its letter, which will be available soon. Owlet didn't immediately respond to The Verge's request for information about its upcoming product and whether it will replace the Smart Sock.
Owlet's Smart Socks have been criticized in the past. Doctors have said that they may put infants at risk because they aren't subject to certain regulations and oversight.
Owlet claims that the Smart Sock was shown to be safe by third parties. The FDA letter we received did not indicate any safety concern about the Smart Sock.