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Masimo lands clearance in U.S. and Europe | Regulatory Roundup

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Masimo

Masimo Corp. (NDSQ:MASI) landed clearance in the U.S. and Europe for its Radical-7 non-invasive pulse oximeter with rainbow acoustic monitoring technology.

The Irvine, Calif.-based company’s system provides doctors with continuous readings of acoustic respiration rate waveform and measurements.

Masimo added a new feature called In Vivo Adjustment, not yet approved by the FDA that allows doctors to account for individual patient biases and adjust the device to readings from invasive blood analysis devices.

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"With the latest Radical-7, we have once again expanded what clinicians can expect from a pulse oximeter; this time by adding the ability to monitor comfortably and reliably a patient’s respiration rate. And, with In-Vivo Adjustment, clinicians can, when they need to, get very accurate measurements that are not only patient focused, but adjusted to their laboratory reference devices," said Joe Kiani, Masimo founder & CEO in prepared remarks.

Masimo posted a strong second quarter driven by a 26 percent boost in sales of its Rainbow SET pulse technology, which hit $9.1 million.

The boost might have been helped along by the long-term non-exclusive agreement Masimo reached earlier this year to integrate its rainbow SET technology into Philips Healthcare’s products.

The company followed its great second quarter earnings report by announcing that its board of directors authorized a repurchase of up to 3 million shares of the company’s common stock, effective August 12.

Regulatory Roundup

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