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

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 technology. The bundle includes a 2K Quad High-Definition camera for video surveillance, and an option without the camera called the Stork Vitals bundle. This alternative connects the Stork vital signs sensor/boot to the Stork app, allowing parents to monitor their baby’s health, and hear, and speak to their little one.

Dr. Ryan S. Bode, a national leader in pediatric hospital medicine and pediatric quality and safety, commented, “I have cared for hospitalized children for over 20 years. In addition, my passion and research interests have focused on quality improvement and patient safety in delivering high-value pediatric care and ensuring optimal patient outcomes. Masimo SET ® pulse oximetry technology is unmatched in its ability to measure accurately even when children move or have low perfusion. Any caregiver, parent, or clinician looking to monitor key vitals in young babies should ensure they have accurate, reliable technology, like SET ® pulse oximetry.”

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Dr. Mitchell R. Goldstein, Professor of Pediatrics at Loma Linda University, said, “I had the privilege of having access to one of the earliest Masimo SET ® pulse oximeters. A young baby, Joshua, came to our unit at extremis, and we attempted all life-saving measures to get his pulse on a non-Masimo device. With no success, we then tried the Masimo monitor and were able to get readings of his vitals, a signal that we should continue to provide care. Joshua survived and was eventually sent home with his parents, and our unit has relied on Masimo SET ® ever since. It is the only pulse oximeter I’m aware of that has provided the ability from the beginning to measure through challenging conditions and with darker skin colors, as was the case with Joshua.”