Masimo has received clearance from the US Food and Drug Administration (FDA) for the prescription use of Stork baby monitoring system on healthy and sick babies aged zero-18 months.

Stork utilises the Masimo sensor technology to ensure continuous and precise monitoring of a baby’s health.

It sends alarms to parents and family members about their baby’s skin temperature, pulse rate (PR), and oxygen saturation (SpO2) when prescribed. These vital sign data can be shared to clinicians remotely.

In addition, the system warns parents when their child turns over and sleeps face down and monitors the temperature of the baby’s room.

Following the FDA approval, Stork is now available at retailers in the US as a non-medical device. The baby monitoring system is intended for general health and wellness purposes.

Masimo founder and CEO Joe Kiani said: “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.

“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.”

According to Masimo, Stork uses the Signal Extraction Technology (SET), which is generally used in the neonatal intensive care unit (NICU).

This technology is embedded in the Stork boot, which is made from a very soft, medical-grade silicone that adapts gently to the baby’s skin.

Stork boot is said to have a sensor to continually and reliably measure the skin temperature, PR, and SpO2 of babies, the medical technology company said.

The Stork Vitals+ bundle consists of the boot along with a 2K Quad High-Definition (QHD) capable camera with technology supported by the TODA platform from Like Minded Labs.