Institute of Good Manufacturing Practices India®

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Masimo’s at-home baby monitor approved for use without prescription

Masimo has obtained FDA approval for its Stork baby monitor, enabling over-the-counter purchase without a prescription. This at-home system, utilizing pulse oximetry technology akin to hospital-grade Masimo devices, monitors oxygen saturation, pulse rate, and skin temperature in infants up to 18 months old. Caregivers are alerted by an alarm if readings deviate from preset ranges. The sensors are incorporated into a wearable boot for ease of use.

Masimo is considering spinning off its consumer business, including the Stork monitor, into a separate entity.

This FDA clearance positions Masimo to compete with Owlet in the over-the-counter pulse oximetry market for at-home baby monitoring. Masimo's Stork device, offering spot-checking and continuous monitoring, supplements parental decision-making. Over-the-counter Stork bundles will be available for purchase online and in retail stores this summer, with existing customers receiving new alarm features through a software update.