US FDA Clearance For Masimo’s Stork Delivers OTC Baby Monitoring Tech Competition

Masimo receives US regulatory clearance for Stork OTC baby monitoring system six months after Owlet received first clearance for its Dream Sock following a regulatory stumble which halted sales of a previous device, Smart Sock, in 2021.

Masimo's Stork OTC monitoring system will expand the bubbling world of baby health wearables. • Source: Shutterstock

Masimo Corp. has received US regulatory clearance for its Stork OTC baby monitoring system six months after a competitor pioneered the market following its regulatory stumble which halted sales of a previous device in 2021.

Masimo on 6 May said OTC Stork is made with the same pulse oximetry technology that is used in its...