Owlet receives FDA clearance for its pulse oximetry sock for infants

Owlet, a tech company focusing on smart baby monitoring, received FDA clearance for its medical pulse oximetry wire-free sock for infants dubbed BabySat. 

BabySat uses pulse oximetry technology to monitor a baby’s heart rate and oxygen saturation level and alerts caregivers when a reading is outside of prescribed ranges. The company says the device is for use per a healthcare provider’s recommendation for babies needing monitoring at home. 

The device is projected to launch this year in the U.S. 

“Our mission is to provide caregivers with the right information at the right time to make informed decisions about their baby’s health,” Kurt Workman, CEO and cofounder of Owlet, said in a statement. “Today, parents whose babies need additional monitoring are sent home with traditional solutions that can be restrictive and more cumbersome for parents. BabySat pushes forward the modernization of hospital-grade technology for at-home use, and underscores our commitment to transforming baby care solutions.”

THE LARGER TREND

Owlet went public in 2021 after merging with a special purpose acquisition company, trading at just under $10 per share on the New York Stock Exchange. Its stock price went up 32% at last look today following the news of BabySat’s FDA clearance, trading at $0.33 per share, well below its initial trading value. 

In late 2021, the company pulled its Smart Sock wearables from the market after receiving a warning letter from the FDA that caused its stock price to tumble. The agency said Owlet was marketing the products as “diagnosis” tools, which would require 510(k) clearance. 

In March 2022, the company launched its consumer-focused sleep wearable for kids up to 5 years old or up to 55 pounds dubbed Dream Sock Plus, which is worn around a child’s foot and is designed to give insights about a child’s sleep. 

Earlier this year, the company announced it raised $30 million in private placement financing and, a month later, reported its fourth-quarter and full-year expenses.

The company reported $69.2 million in revenue in 2022 compared to $75.8 million in 2021, with an increase in operating expenses of $107.9 million in 2022, compared to $90.9 million in 2021. Owlet said the increase was largely due to the launch of its Dream Sock early in the year. 

Owlet cut expenses in the second half of 2022 as it made new submissions to the FDA, pitching the moves as steps toward profitability.