FDA Grants De Novo Clearance to Owlet’s Dream Sock: © Andrey – stock.adobe.com
Owlet announced that the FDA has approved De Novo clearance for its Dream Sock, making it the first and only over-the-counter medical-grade pulse oximeter approved for use in infants.1
Main points
- Owlet’s Dream Sock has received FDA De Novo approval, marking it as the first over-the-counter medical-grade pulse oximeter approved for use in infants. This means the regulatory agency has approved its use for monitoring health parameters in infants.
- The Dream Sock is designed to monitor and display real-time health readings for infants aged 1 to 18 months and weighing 6 to 30 pounds. It tracks metrics like oxygen saturation and pulse rate, providing caregivers with real-time data. If readings exceed preset parameters, health notifications are triggered.
- Alisa Niksch, MD, a pediatric cardiologist and senior director of medical affairs at Owlet, is proud of the Dream Sock’s accuracy validation against the gold standard for pulse oximeters. This emphasizes the reliability of the device in supporting home infant care.
- The article mentions Owlet’s history with the FDA, including a 2016 warning about misclassification of its smart socks. In 2021, Owlet withdrew its smart socks from the market after the FDA warned that its health readings could indicate bradycardia and desaturation.
- Dream Sock’s FDA-approved features are expected to be implemented by the end of 2023 for new and existing users in the United States. This underscores Owlet’s commitment to providing parents with advanced, accurate infant monitoring technology.
The Dream Sock is designed to monitor and display real-time health readings for babies, such as oxygen saturation and pulse rate. The device provides health notifications to caregivers when readings exceed preset parameters. This approval applies to infants aged 1-18 months and weighing 6 to 30 pounds.
“We are all very proud that Dream Sock has been validated against the gold standard for pulse oximeter accuracy and has stood up to this challenge,” said Alisa Niksch, MD, pediatric cardiologist and senior director of medical affairs at Owlet. “Through this process, we have fully understood the capabilities of our products in supporting at-home infant care. “We are excited to continue our research efforts to bring new technologies and advancements in infant monitoring accuracy to parents.” “
Owlet also previously received FDA approval for its BabySat, a prescription-only monitoring system that uses pulse oximetry technology in a wireless design for infants with acute or chronic illnesses. According to the company, BabySat can display a baby’s oxygen saturation and pulse rate in real time and, like the Dream Sock, can alert caregivers when a baby’s readings fall outside prescribed ranges.
Prior to these clearances, the FDA had been in contact with Owlet since 2016 regarding misclassification of Owlet smart socks.2
In 2021, Owlet pulled its smart socks from the market after the FDA issued a warning, arguing that the device provided health readings that could notify caregivers of potential bradycardia and desaturation.2
“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 in affecting the structure or function of any body,” the FDA wrote in a warning letter to Owlet. “
The company announced that these new FDA-approved features will be implemented for new and existing Dream Sock users in the United States by the end of 2023.1
refer to:
- FDA Approved – Owlet USA. owl. November 9, 2023. Accessed 9 November 2023. https://www.owletcare.com/fda-response, https://www.owletcare.com/fda-response
- Park A. Owlet pulls baby-monitoring smart socks from the market after FDA warning. Intense biotech. November 29, 2021. Accessed 9 November 2023. https://www.fiercebiotech.com/medtech/owlet-pulls-baby-monitoring-smart-sock-from-market-after-fda-warning