FDA grants De Novo clearance to Owlet’s Dream Sock: © Andrey - stock.adobe.com
Owlet has announced the FDA has granted De Novo clearance to its Dream Sock, making it the first and only over-the-counter medical-grade pulse oximeter that is cleared for use in infants, according to the company.1
- Owlet has received FDA De Novo clearance for its Dream Sock, marking it as the first over-the-counter medical-grade pulse oximeter approved for use in infants. This signifies a regulatory green light for its use in monitoring infants' health parameters.
- The Dream Sock is designed to monitor and display live health readings in infants aged 1-18 months and weighing 6 to 30 lbs. It tracks metrics such as oxygen saturation levels and pulse rates, providing caregivers with real-time data. Health notifications are triggered if readings fall outside preset parameters.
- Alisa Niksch, MD, a pediatric cardiologist and senior director of medical affairs at Owlet, expressed pride in the Dream Sock's accuracy validation against gold standards for pulse oximetry devices. This emphasizes the device's reliability in supporting at-home infant care.
- The article mentions Owlet's history with the FDA, including a warning in 2016 about the misclassification of its Smart Sock. In 2021, Owlet withdrew the Smart Sock from the market following an FDA warning regarding its health readings potentially indicating bradycardia and desaturation.
- The FDA-cleared features for the Dream Sock are expected to be implemented for both new and existing users in the United States by the end of 2023. This underlines Owlet's commitment to delivering advanced and accurate infant monitoring technologies to parents.
The Dream Sock is designed to monitor and display an infant’s live health readings, such as oxygen saturation level and pulse rate. The device provides health notifications to caregivers in the instance of readings falling outside of preset parameters. This clearance is for the device's use in infants 1-18 months and 6 to 30 lbs.
“We’re all so proud that the Dream Sock was validated against the gold standards of accuracy for pulse oximetry devices – and stood up to that challenge,” said Alisa Niksch, MD, pediatric cardiologist and senior director, medical affairs, Owlet. “Throughout this process, we learned a tremendous amount about the capabilities of our product in supporting the care of babies in the home. We're excited to continue our research efforts as we bring new technologies and advancements in accuracy in infant monitoring to parents.”
This clearance follows a previous clearance from the FDA for Owlet’s BabySat, a prescription-only monitoring system that utilizes pulse oximetry technology in a wire-free design for infants with acute or chronic medical conditions. According to the company, BabySat delivers a real-time display of an infant’s oxygen saturation level and pulse rate, and just like the Dream Sock, alerts caregivers when the infant’s readings fall outside of the prescribed ranges.
Prior to these clearances, the FDA has been in contact with Owlet regarding the misclassification of its Smart Sock since 2016.2
In 2021, Owlet pulled its Smart Sock from the market following a warning from the FDA citing that the device provides health readings, which can notify caregivers about potential cases of bradycardia and desaturation.2
In their warning letter to Owlet, the FDA wrote, “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 company announced that these new FDA-cleared features will be implemented for new and existing Dream Sock users in the United States by the end of 2023.1
- FDA clearance – Owlet US. Owlet. November 9, 2023. Accessed November 9, 2023. https://www.owletcare.com/fda-response, https://www.owletcare.com/fda-response
- Park A. Owlet pulls baby-monitoring Smart Sock from market after FDA warning. Fierce Biotech. November 29, 2021. Accessed November 9, 2023. https://www.fiercebiotech.com/medtech/owlet-pulls-baby-monitoring-smart-sock-from-market-after-fda-warning