Masimo’s High Accuracy RD SET Pulse Oximeters Cleared by FDA

Masimo
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Masimo won FDA clearance for its RD SET sensors that feature the company’s “Measure-through Motion” and “Low Perfusion SET” pulse oximetry. The new disposable oximeters are supposedly twice as accurate than Masimo’s previous offerings for patients over 3 kg, having an accuracy spec of 1.5% at 1 standard deviation, compared to 3% before.

The devices are purportedly also more comfortable for the patients to wear and easier to handle by clinicians. The cable is flat and lies along the patient’s finger, while having curved edges to prevent irritation.

“We’re delighted to be able to announce our continued innovation in our foundational SET®pulse oximetry,” said Joe Kiani, Founder and CEO of Masimo, in a published statement. “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.”

Masimo’s High Accuracy RD SET Pulse Oximeters Cleared by FDA