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Masimo Introduces Pronto-7™ Internationally and Lifts Voluntary Recall
Date:8/8/2011

IRVINE, Calif., Aug. 8, 2011 /PRNewswire/ -- Masimo (NASDAQ: MASI) announced today that it has lifted the voluntary product recall the company imposed on the noninvasive finger sensor of its Pronto-7 handheld device to improve the product's performance in low ambient temperatures. The Pronto-7 and new finger sensors are pending FDA 510(k) clearance in the U.S.  

(Photo: http://photos.prnewswire.com/prnh/20110808/LA48532 )

New product features and enhancements include the addition of Max Sensitivity Mode that allows measurement over a broader range of patients.  The addition of three noninvasive sensor sizes permits the instrument to be used on a broader range of finger diameters.  Each of the new sensors is color-coded to make size identification easy (Small-Yellow, Medium-Red, and Large-White).  

Masimo Founder and CEO, Joe Kiani, stated:  "We take the integrity of our design and our promises to our customers seriously.  We worked through the recall until we had redesigned the sensor for Pronto-7 so that it would perform as intended in the broadest range of likely ambient temperatures.  We are delighted to re-introduce the Pronto-7 and with it the potential impact of noninvasive hemoglobin spot-check measurements that offer healthcare providers around the world the opportunity to transform the way and amount of time it takes to deliver the right care, at the right time to patients. We believe that Pronto-7's latest features and enhancements will help clinicians to better assess more patients and make better clinical decisions based on the availability of these quick and noninvasive hemoglobin measurements."

As part of Masimo's premarket testing and verification process, over 14,443 Pronto-7 measure
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