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

ments were performed on 1,443 subjects at 14 sites and compared to hemoglobin measurements from a venous blood sample analyzed on a hematology analyzer (Coulter Counter).  This testing resulted in a product specification of 1.0 g/dL for normal sensitivity mode and 1.1 g/dL for max sensitivity mode.  While not a regulatory requirement, prior to lifting the voluntary recall Masimo elected to perform additional testing on Pronto-7 devices and sensors produced at a Masimo manufacturing facility. This additional testing included 474 subjects in three outpatient clinic-type environments.  The hemoglobin measurements from the Pronto-7 and a point of care device using capillary blood (Hemocue) were compared to hemoglobin measurements from a venous blood sample analyzed on a Coulter Counter.  The Hemocue showed a bias of -0.1 g/dL and a standard deviation of 1.6 g/dL, while the Pronto-7 showed a bias of was -0.1 g/dL and a standard deviation of 1.1 g/dL. Based on the clinical results obtained and positive feedback from clinicians, Masimo has initiated international availability of Pronto-7 in Europe, Middle East, Africa, South America, and Asia (except for countries requiring clearance, such as Japan).

About Masimo

Masimo (NASDAQ: MASI) is the global leader in innovative noninvasive monitoring technologies that significantly improve patient care—helping solve "unsolvable" problems.  In 1995, the company debuted Measure-Through Motion and Low Perfusion pulse oximetry, known as Masimo SET®, which virtually eliminated false alarms and increased pulse oximetry's ability to detect life-threatening events.  More than 100 independent and objective studies demonstrate Masimo SET provides the most reliable SpO2 and pulse rate measurements even under the most challenging clinical conditions, including patient motion and low peripheral perfusi
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