Masimo’s FDA clearance for Stork to redefine OTC baby monitoring market, says GlobalData

The COVID-19 pandemic has significantly accelerated the pace of innovation in the healthcare IT market, as health systems worldwide have rapidly adapted to new technologies to manage unprecedented challenges. The shift towards remote healthcare and increased consumer interest in health monitoring at home has driven demand for advanced healthcare technologies, including baby monitoring systems. The US Food and Drug Administration (FDA) recently cleared Masimo‘s Stork device for over-the-counter (OTC) sales, which positions the company as a significant player in the pulse oximetry devices market to monitor babies at home, says GlobalData, a leading data and analytics company.

According to GlobalData forecasts, the Remote Patient Monitoring (RPM) market will reach $760 million by 2030, up from $548.9 million in 2020 with a compound annual growth rate (CAGR) of 3.3% over the period, driven by technological advancements and increasing consumer demand for at-home monitoring solutions.

Kamilla Kan, Senior Data Scientist at GlobalData, comments: “The surge in demand for remote monitoring devices sets the stage for companies like Masimo and Owlet, who are vying for leadership in the increasingly competitive pulse oximetry devices market for home use. The Stork system, designed for spot-checking and continuous monitoring of infants at home, is part of a broader trend where parents are increasingly looking for sophisticated health monitoring solutions.”

With its established presence in medical technologies, Masimo’s foray into the consumer health space with the Stork device is a natural extension of its brand into adjacent markets. Owlet’s baby monitor was approved by the FDA in 2023 and is available without prescription in the US.

Kan concludes: “Masimo’s strategic realignment towards consumer health, coupled with ongoing innovation and regulatory support, could redefine its market trajectory and enhance its competitive edge against companies like Owlet.

“As the company navigates through these changes, including facing a second proxy challenge from Politan Capital aiming for additional board seats, the implications for Masimo’s market position and investor relations are substantial. These developments highlight the evolving dynamics of the healthcare technology market and the increasing intersection of consumer preferences and professional healthcare solutions.”

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