The FDA approval allows commercialisation of its RD SET sensors, with improved performance specifications, for all patient populations in the US
Global medical technology company Masimo has secured the US Food and Drug Authority (FDA) approval of its RD SET sensors with Masimo measure-through motion and low perfusion SET pulse oximetry.
The regulatory body has approved the pulse oximetry device for enhanced oxygen saturation (SpO2) accuracy specifications for neonatal patients, weighing more than 3kgs.
The patient monitoring technologies provider said that the FDA approval allows commercialisation of its RD SET sensors, with improved performance specifications, for all patient populations in the US.
Masimo founder and CEO Joe Kiani 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. Even though no one has been able to create pulse oximetry that outperforms SET, we have not allowed that to stop us from continuing our pursuit of perfecting pulse oximetry.”
RD SET sensors will improve SpO2 accuracy specifications and enhance patient comfort
The company said that its sensors are designed to be light in weight, have a flat, soft cable with smooth edges, enabling them to lie comfortably on a patient’s hand or foot.
Its RD SET NeoPt sensors with Velaid SofTouch will barely use adhesive, and facilitates speedy application and repositioning on the delicate skin of newborns and pre-term babies.
In addition, lightweight design of the RD SET sensors would result in the reduction of waste and the sleek, recyclable packaging reduces storage and shipping space.
Masimo said that its updated RD SET sensors would improve SpO2 accuracy specifications, enhance patient comfort and clinicians’ confidence while monitoring the oxygenation status of neonates, optimise clinician workflows, and help hospitals meet green initiatives.
The advanced SET pulse oximetry device, prior to the revisions to improve accuracy specifications, is claimed to have outperformed other pulse oximetry technologies in more than 100 independent and objective studies.
In addition, SET is said to help clinicians in reducing critical retinopathy of prematurity in neonates and improve CCHD screening in newborns, in multiple studies.