Owlet, a company focused on smart infant monitoring, has received de novo clearance from the U.S Food and Drug Administration (FDA) for its Dream Sock, an over-the counter medical pulse oximeter for babies.
 
Dream Sock monitors and displays “Baby’s Live Health Readings” that include pulse rate and oxygen saturation level. It issues health notifications to alert caregivers with lights and alarm sounds if their baby’s readings move outside of set ranges.
 
The technology was cleared for use in healthy infants between 1-18 months and six to 30 pounds.
 
“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,” Owlet co-founder and CEO Kurt Workman told the press.
 
“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,” added Dr. Alisa Niksch, pediatric cardiologist and senior director of 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.”
 
Dream Sock’s clearance follows the company’s June FDA nod for the prescription infant monitoring device BabySat.