Benson Morgan, 2 months old, wears an Owlet Vitals Monitor on Thursday, Sept. 5, 2013. Following receipt of a warning letter from the U.S. Food and Drug Administration, Owlet will stop selling the product until it earns medical device approval from the FDA. | Laura Seitz, Deseret News
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.
Alex Goodlett, Deseret News
Owlet co-founder Kurt Workman poses …read more
Source:: Deseret News – Utah News
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