FDA grants 510(k) clearance to pulse oximeter device for infants

The FDA has granted 510(k) clearance to a prescription pulse oximeter in the form of a sock for monitoring oxygen saturation levels of infants, according to a manufacturer-issued press release.

According to the release, the BabySat monitoring system (Owlet) allows physicians and parents/guardians to oversee a baby’s real-time oxygen saturation levels and heart rate at home. With tracking of both these health measures, the device/system knows when either go out of their prescribed range and alerts parents/guardians.

Owlet hopes this device/system will help parents/guardians feel confident in caring for their baby at home as they will have the ability to look at health metrics and feel reassured that a physician is supervising these readings, according to the release.

“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 co-founder of Owlet Baby Care, said in the release. “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.”

According to the release, BabySat has a target launch date of later this year in the U.S.