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US FDA Clearance For Masimo’s Stork Wakes Up OTC Baby Monitoring Technology Competition

 
• By Malcolm Spicer

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.

• 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 devices for monitoring more than 10m annually in hospital neonatal

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