#BabyHealthMonitoring

Did Masimo Receive FDA Clearance for the Stork Baby Monitoring System?

Author(s): MedEdge MEA

Irvine, USA- Masimo, a global leader in innovative monitoring technologies, has achieved FDA clearance for Stork™, an advanced baby monitoring system designed for prescription use with babies aged 0-18 months. Utilizing Masimo’s proven sensor technology, the same trusted by hospitals for over 10 million babies annually, Stork offers continuous and precise monitoring of a baby’s health. While available nationwide for general health and wellness as a non-medical device, Stork’s FDA clearance now enables its prescription use for at-home medical monitoring of both healthy and sick babies.

“When my son was born, we were concerned about his breathing. Our doctor prescribed pulse oximetry monitoring for a week for him. A therapist arrived at our home with a large standalone pulse oximeter made for hospitals, with cables and wires everywhere and tethered to our son, and charged us $5,000 for a week of monitoring,” said Joe Kiani, Founder and CEO of Masimo. “I know how important it is for parents to better understand their baby’s physiological well-being, especially when they are sick, and it’s our privilege to provide them with an easy-to-use, accurate product that allows them to continuously monitor key vital signs for less than one-tenth of the cost I paid, and also includes video surveillance.”

Stork’s technology, known as Signal Extraction Technology ® (SET ®), has a proven track record in neonatal intensive care units, aiding in reducing neonatal blindness and enhancing screening for critical congenital heart disease. Stork’s performance specifications, notably its SpO2 accuracy, make it a reliable choice even during a baby’s movement.

The Stork Vitals+ bundle features a sleek design with a medical-grade silicone boot housing the innovative sensor....READ MORE

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Did Masimo Receive FDA Clearance for the Stork Baby Monitoring System? MedEdge MEA

Irvine, USA- Masimo, a global leader in innovative monitoring technologies, has achieved FDA clearance for Stork™, an advanced baby monitoring system designed for prescri...

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