Neonatal oxygen sensors receive FDA clearance

Jan. 3, 2020

Masimo announced that RD SET sensors with Masimo Measure-through Motion and Low Perfusion SET pulse oximetry have received U.S. Food and Drug Administration (FDA) clearance for improved oxygen saturation (SpO2) accuracy specifications for neonatal patients (< 3 kg). The updated RD SET sensors' SpO2 accuracy specifications have improved significantly, from 3% to 1.5% ARMS1 (at 1 standard deviation), in conditions of motion and no motion. With this clearance, the improved performance specifications, which were incorporated into RD SET sensors for patients > 3 kg in 2018, are now available to all patient populations in the U.S.

Masimo's RD SET sensors have been shown to help clinicians reduce severe retinopathy of prematurity in neonates and in multiple studies, including the largest critical congenital heart disease (CCHD) study to date, to improve CCHD screening in newborns. The sensors are lightweight and have a flat, soft cable with smooth edges, so that they lie comfortably on a patient's hand or foot. In particular, RD SET NeoPt sensors with Velaid SofTouch use little to no adhesive, facilitating quick but gentle application and repositioning on the fragile skin of newborns and pre-term babies. RD SET sensors also feature a sensor-to-cable connection, a lightweight design that results in up to 84% less waste and recyclable packaging that reduces storage and shipping space.

Joe Kiani, Founder and CEO of Masimo, said, "We're delighted to announce the latest result of our continued innovation in our foundational SET pulse oximetry. We have long been dedicated to helping improve the lives of neonatal, infant, and pediatric patients, and this clearance significantly furthers that mission. Thanks to the brilliance and dedication of our engineers and the continuing support of our customers, we’ve been able to once again raise the standard for pulse oximetry performance.”

Masimo has the announcement.