Owlet is no longer selling its Smart Sock vital sign monitors for babies and toddlers after the FDA informed the company that the devices had been improperly brought to market.
The Smart Sock can be worn by children ages 0 to 5 to track their sleep patterns, blood oxygen saturation and pulse rate. The device automatically transmits the collected data to a connected base station and smartphone app in real time and issues alerts if the readings leave a predetermined range.
In early October, the agency sent a warning letter to Owlet noting that because the Smart Sock measures vital signs including blood oxygen levels and heart rate and uses those readings to alert caregivers to potential cases of desaturation or bradycardia, it should be classified as a medical device and therefore requires FDA clearance before being sold.
“These products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or prevention of disease, or to affect the structure or any function of the body,” the regulator wrote.
A disclaimer on Owlet’s website, meanwhile, still warns customers that “Owlet products are not medical devices.” It adds, “They do not and are not intended to diagnose, cure, treat, alleviate or prevent any disease or health condition or investigate, replace or modify anatomy or any physiological process.”
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In its letter, the FDA said it has corresponded with Owlet about the misclassification of its Smart Sock since 2016. It requested that the company stop selling the devices immediately and begin the process of submitting the monitoring technology for standard regulatory clearance.
The FDA also gave Owlet 15 days to respond to the warning letter with details of “the specific steps your firm has taken to address any violations, as well as an explanation of how your firm plans to prevent any violations from occurring again.” Within a few days of receiving the letter, Owlet announced it was already formulating its response.
“We are fully cooperating with the FDA on the regulatory status of the product,” the company said in an Oct. 4 statement. “We have been engaged with the FDA to ensure our products abide by the agency’s guidance and expectations, and we will continue working closely with the FDA to reach a resolution.”
A month later, when Owlet shared its third-quarter financial results Nov. 10, CEO Kurt Workman said the company was still in discussions with the FDA regarding “a path forward for our medical device application for the Smart Sock.”
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In the latest update to the saga, however, as of last week, Owlet has stopped selling the wearable monitor and is now planning to replace it with a completely new health-tracking device and accompanying app, according to a notice dated Nov. 22.
“We plan to offer a new sleep monitoring solution, which we believe will be available soon,” the company said in another statement on its website. The message adds that Owlet is still pursuing FDA authorization for its heart rate and blood oxygen level notifications and reminds users that the initial FDA letter didn’t identify any safety issues with the device, only with its marketing, making it safe for continued use by existing customers.
Additionally, while the Smart Sock can no longer be purchased from Owlet’s website nor via Amazon, as of Monday afternoon, it’s still available from other online retailers including Buy Buy Baby and Bed Bath & Beyond.