Owlet Baby Care, the Utah-based tech startup producing innovative baby care and parenting products, has stopped the commercial distribution of its Smart Sock Baby Monitor in the US after the Federal Food and Drug Administration (FDA) issued a warning letter. The news was first reported by DeseretNews.
Owlet Smart Sock Baby Monitor is a lightweight smart baby monitoring sock-like device that wraps around a child’s foot. It monitors babies’ vital signs such as heart rate, blood oxygen levels, and sleep patterns and allows parents to view them in real-time. It comes with a smartphone app that alerts caregivers or parents when a baby’s readings fall outside of the stipulated precincts. FDA wants the product to be classified as a medical device in the U.S. because of the heart rate and oxygen notifications.
According to the FDA notice, “Owlet Smart Socks are offered for sale in the United States without marketing approval, clearance, or authorization from FDA.” The agency has alerted Owlet about its marketing claims which render the product as a medical device as it uses infrared light to detect a baby’s heart rate and blood oxygen level. This kind of device would customarily need premarket FDA clearance or approval, which Owlet has failed to obtain. It is on this ground that the FDA has asked the company to cease commercial distribution of the Smart Sock as a product for measuring blood oxygen saturation and pulse rate.
Owlet has also posted ‘FDA Response’ on their site affirming the fact that the agency did not identify any safety concerns about the Smart Sock. The company is moving forward to pursue marketing authorization from the FDA for these features that require it to be classified as a medical device in the U.S.
Owlet has marketed Smart Sock as an award-winning product that tracks “the most important indicators of your baby’s well-being” while they rest.
- Reddit Is Clearing Up Old Chats And Messages - July 13, 2023
- Toyota Debuts All-Electric Futuristic SUV Concept Under Its bZ Brand Umbrella - November 17, 2022
- Microsoft Announces Microsoft Dev Box Preview - August 16, 2022
