Owlet, a frontrunner in smart infant monitoring technology, has recently obtained De Novo clearance from the U.S. Food and Drug Administration for its Dream Sock product. This marks a significant development in infant care technology as Dream Sock stands as the only over-the-counter, medical-grade pulse oximeter designed specifically for infants.
The Dream Sock by Owlet is engineered to keep track of a baby’s vital health metrics, such as pulse rate and oxygen saturation levels. In addition, it is equipped with Health Notifications to alert caregivers if the infant’s readings deviate from pre-established parameters. This innovative feature will be available to all users of Dream Sock, with a launch date set to be announced shortly.
“Today marks a significant breakthrough in our journey to bring care to the home and empower parents with an unprecedented FDA-clearance for the Owlet Dream Sock,” said Kurt Workman, Owlet Chief Executive Officer and Co-Founder. “This accomplishment not only signifies our commitment to innovation in the infant health category but, more importantly, our dedication to ensuring the health and well-being of every baby. With this De Novo clearance, we are proud to set new standards in at-home infant care, arming parents with reliable real-time information and providing enhanced peace of mind.”
This FDA clearance signifies the reliability and safety of Dream Sock, which has undergone extensive clinical testing in various environments (e.g. in hospital or also at home) to ensure it matches the accuracy of medical-grade monitoring devices. Owlet’s commitment to innovation is reflected in this achievement, with the technology validated against the highest standards of accuracy for pulse oximetry devices.
“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 Dr. Alisa Niksch, Pediatric Cardiologist and Senior Director Medical Affairs at 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.”
The clearance of Dream Sock follows Owlet’s earlier FDA-approved BabySat, a prescription-based monitoring system. While BabySat caters to infants with specific medical conditions, Dream Sock makes medical-grade monitoring accessible to healthy infants without the need for a prescription.
The FDA-approved features are expected to be rolled out to both new and existing users in the United States by the end of this year. Owlet’s mission continues to be providing parents with the necessary tools to ensure their infants’ well-being, backed by the latest advancements in digital health technology.