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Masimo Pronto-7™ Receives Japanese and Canadian Regulatory Clearances
Date:8/29/2011

al hemoglobin, SpO2, perfusion index, and pulse rate in less than one minute without the needles, time-consuming laboratory analysis, risk of blood contamination, hazardous medical waste, and patient discomfort associated with traditional blood tests.  With dimensions of just 13 cm x 7.2 cm x 2.5 cm (5.1" x 2.8" x 1") and weight of 296 grams (10.5 ounces), the palm-sized Pronto-7 puts the power of noninvasive hemoglobin spot-check testing, along with SpO2, perfusion index, and pulse rate into any clinician's hands in various clinical settings—including physician offices, hospitals, clinics, and on the scene of medical emergencies.  

In addition to Normal Mode, Pronto-7 offers Max Sensitivity Mode that allows measurement over a broader range of patients and three noninvasive sensor sizes to accommodate the range of finger diameters.  Each sensor is color-coded to make size identification easy (Small-Yellow, Medium-Red, and Large-White) and optimized to improve performance in low ambient temperatures. And, because of the device's embedded 802.11 b/g and Bluetooth communication capability, wireless printing or emailing of test results is enabled with future upgrades that will allow for wireless transmission to electronic health record (EHR) systems.

Prior to the introduction of the Pronto-7, Masimo received U.S. FDA 510(k) and CE Mark clearance and first introduced the ability to noninvasively and continuously measure total hemoglobin (SpHb) in 2008 using its Radical-7 bedside Pulse CO-Oximeter.  In 2009, Masimo launched Pronto®—its first handheld noninvasive spot-check device for total hemoglobin, SpO2, perfusion index, and pulse rate measurements.  And in 2010, Masimo established Medicare reimbursement for transcutaneous hemoglobin measurement in the United States.  

Masimo Founder and CEO, Joe Kiani, stated: "The potential impact of noninvasive total hemoglobin, SpO2, perfusion index, and pulse rate
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