FDA clears over-the-counter Stork baby monitor from Masimo

Masimo(Nasdaq: MASI)+ announced today that the FDA cleared its Stork baby monitoring system for over-the-counter use. […]

Masimo(Nasdaq: MASI)+ announced today that the FDA cleared its Stork baby monitoring system for over-the-counter use.

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 received its initial FDA clearance in December 2023. The company already began its U.S. rollout to major retailers in August, having kicked off its initial launch in May. Now, the company can provide its technology for use with healthy babies between 0-18 months of age without the need for a prescription.

The FDA-cleared over-the-counter version of Masimo Stork monitors a baby’s key vitals data, including oxygen saturation level (SpO2), pulse rate (PR) and skin temperature. Stork notifies caregivers with visual and audible alarms if a baby’s SpO2 or PR readings fall outside of preset ranges.

Masimo designed Stork to utilize its Signal Extraction Technology (SET) for pulse oximetry. The technology helps reduce the incidence of neonatal blindness from retinopathy of prematurity. Masimo says it led to significant improvements in screening newborns for critical congenital heart disease.

“I believe that by empowering parents and caregivers with the same Masimo pulse oximetry technology that hospitals have been using on babies for decades, we can help them feel more informed and confident when caring for their baby,” said Joe Kiani, founder and CEO of Masimo. “I am so proud of our team for Stork – it is a culmination of science and design at its best.”

More about the Masimo Stork system

The company’s SET sensor nests within the Stork boot, made from an ultra-soft, medical-grade silicone. This boot conforms gently to the baby’s skin and comes in three sizes to ensure a perfect fit as the child grows.

Masimio designed Stork as a sleek, minimalist option to fit seamlessly into any nursery and onto the baby’s foot. Its camera hardware and software architecture can work with future edge AI-based features currently under development.

The system’s clearance covers the monitoring of multiple physiological parameters. Masimo Stork is indicated for spot-checking and continuous monitoring of SpO2 and PR during no-motion, motion, and low-perfusion conditions in infants and neonates 0 to 18 months of age and between 6 and 30 lbs. It is also indicated for continuous skin temperature measurements of infants and neonates in the same age and weight range. Stork’s indication covers use in home environments.

Masimo currently sells Stork bundles at major and specialty retailers in the U.S. It sells the system as a non-medical device for general health and wellness purposes. The company plans to make new alarm features available to all existing and new users through its Stork App. It expects to release that update this summer.

Original article (https://www.massdevice.com/fda-clears-otc-stork-baby-monitor-masimo/)