Masimo’s RD sensors with improved accuracy gets USFDA approval

The USFDA approved, Masimo for its RD sensors with enhanced accuracy specifications for SET pulse oximetry.The RD SET sensors with Masimo measure-through motion and low perfusion SET pulse oximetrynow have USFDA clearance with improved SpO2 accuracy specifications for all patients above 3kg. This means that the RD SET sensors SpO2 specifications have improved for adult, paediatric, and infant patients to 1.5% as compared to the previous accuracy specifications of 3%.

With an advanced sensor-to-cable connection, the sensors are lightweight and have recyclable packaging to help reduce storage and shipping space.

Studies have shown that Masimo SET helped reducethe rates of severe retinopathy of prematurity (ROP) and the need for laser treatment, it also allowed pulse oximetry screening for critical congenital heart disease (CCHD).The use of Masimo SET reduced rescue calls and ICU transfers by 65% and 48% on post-surgical wards.

Furthermore, studies also demonstrated that post-operative continuous surveillance monitoring, along with the Masimo SET, led to zero preventable deaths or brain damage because of opioids over five years.

“We’re delighted to be able to announce our continued innovation in our foundational SET pulse oximetry. 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.” said, Joe Kiani, founder and CEO of Masimo. “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 the technology.”

Masimo is non-invasive technology developer, who aims at improving patient outcomes and lower the cost of care.


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