Owlet, based in Lehi, has halted sales of its popular baby monitoring socks following a warning from the Food and Drug Administration, prompting outrage from some parents.
The FDA warned Owlet in an October letter that the socks are medical devices “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,” and that they must apply for marketing clearance.
Owlet creates a connected and accessible nursery for babies using technology and data, providing parents with real-time updates and insights into their baby’s health. The Owlet Smart Sock, now in its third generation, the Owlet Cam, a smart HD video baby monitor, the Dream Lab sleep guide, and the Owlet Pregnancy Band, which is still in beta testing and monitors the vitals of unborn babies, are among the company’s products.
The agency threatened penalties if Owlet did not remove its Smark Sock from the market, according to the letter.
“The FDA will evaluate the information that your firm submits and decide whether the product may be legally marketed,” the FDA stated.
Owlet stated in an FDA Response post:
“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. 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
Owlet also stated that the letter “did not identify any safety concerns about the Smart Sock,” which will be a welcome news to the over a million parents who have purchased one.
As of Wednesday, a Change.org petition opposing the federal agency’s decision had gathered nearly 60,000 signatures, with dozens of parents sharing how the Smart Sock has given them peace of mind, and some even claiming that it has saved their child’s life.
The Smart Sock uses pulse oximetry, a noninvasive method of measuring hemoglobin saturation in the blood, to monitor a baby’s heart rate, blood-oxygen levels, and sleep patterns while they sleep, and notifies parents of any changes via an app notification so they can assist their child.
Owlet officials said in July that 28.5 percent of Utah babies leave the hospital with a Smart Sock, and the company has used the data to compile the world’s largest data set on infant health.
In the meantime, sales of the Smart Sock have been halted as Owlet prepares to submit a device application to the FDA.
The product has been on the market for six years, according to Owlet officials. According to the company, the socks have been used to monitor over 1 million babies.