Owlet has submitted a 510(k) premarket notification to the U.S. FDA for a new prescription monitor device for infants.
The company’s prescription monitor device, which uses pulse oximetry technology, is intended to be prescribed by physicians for assisting with the in-home monitoring of babies under a physician’s care. The device provides alerts to parents when their baby’s heart rate or oxygen saturation level does not fall within prescribed ranges.
“As noted in our recent earnings release, this is a major milestone for Owlet as we work toward our mission, representing several years of work, including clinical and safety studies,” says Kurt Workman, Owlet president, CEO and co-founder. “This device will help the most vulnerable of babies, and we are optimistic about and excited for the opportunity ahead as we develop and expand our core technologies to include medical devices. I’m grateful to our team who has worked tirelessly on this initiative, and we look forward to working through the FDA review process.”
Owlet was founded by a team of parents in 2012. The company says its mission is to empower parents with the right information at the right time. Owlet’s digital parenting platform aims to give parents real-time data and insights to help parents feel calmer and more confident.