Masimo wins FDA nod for improved RD SET sensors

Masimo (NSDQ:MASI) said today it won FDA 510(k) clearance for its RD SET sensors with measure-through motion and low perfusion SET pulse oximetry.

The newly cleared sensors feature improved SpO2 accuracy specifications for patients under 3kg, the Irvine, Calif.-based company said, and are designed to improve accuracy, patient comfort and clinician workflows.

“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. 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. We have significantly improved our accuracy during motion and this is just the start of further improvements in what clinicians can expect from pulse oximetry,” founder & CEO Joe Kiani said in a prepared statement.

Last month, Masimo said that it won FDA clearance for its RAS-45 acoustic respiration sensor as part of its Rainbow Acoustic Monitoring system, cleared for use with infants and neonatal patients.

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