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FDA clears Masimo Stork home baby monitoring system

The FDA today published a 510(k) premarket notification granting clearance to the Stork baby monitoring system from Masimo

Stork offers a continuous and accurate view of a baby’s health data. It leverages Masimo’s noninvasive neonate monitoring technologies.

Masimo’s smart home baby monitoring system officially received its clearance on Dec. 15. The company already began its U.S. rollout to major retailers in August, having kicked off its initial launch in May. BTIG analysts Marie Thibault and Sam Eiber say the company plans to ramp up to around 250 outlets by year-end. They expect approximately 1,000 by 2024.

According to the analysts, prices range from $249 to $549, depending on the bundle for the Stork system. They say Masimo projects a market opportunity for Stork at around $500 million, making it a “premium segment” in baby monitoring.

“We remain bullish on Stork since we believe this represents an adjacent market opportunity that is closest to [Masimo’s] strengths in healthcare technology,” the analysts wrote. “We wait for more details on the indications for use once it is published on the database. We do not make any changes to our model at this time.”

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