June 30, 2010 (FinancialWire) — Masimo (NASDAQ: MASI) said it has received FDA 510(k) clearance for the company’s Pronto-7, a new handheld device designed for noninvasive hemoglobin spot-check testing, along with SpO2, pulse rate, and perfusion index.

A low hemoglobin level is called anemia, a pervasive blood disorder that, according to the World Health Organization, affects 1.6 billion people worldwide and causes one million deaths a year.

Chronic anemia is characterized by consistently low hemoglobin levels that can be the result of a diet deficiency or illness such as cancer. Acute anemia is a sudden drop in hemoglobin levels that can result from internal or external bleeding due to surgery or trauma.

Hemoglobin is a commonly ordered tests in both hospital and non-hospital settings because it is critical to assessing anemia and blood loss. However, traditional lab testing requires a painful needle stick for the patient, time-consuming blood draws for the clinician, and typically provides delayed results.

According to Masimo, the palm-sized Pronto-7 measures hemoglobin in less than one minute, without the need for needles or laboratory analysis, hazardous medical waste and patient discomfort associated with traditional blood tests.

California-based Masimo develops monitoring technologies. In 1995, the company debuted Measure-Through Motion and Low Perfusion pulse oximetry, known as Masimo SET, which offer SpO2 and pulse rate measurements.

In 2005, Masimo introduced Rainbow Pulse CO-Oximetry, allowing noninvasive and continuous monitoring of blood constituents that previously required invasive procedures, including total hemoglobin, oxygen content, carboxyhemoglobin, methemoglobin, and Pleth Variability Index, in addition to SpO2, pulse rate, and perfusion index.

In 2009, Masimo introduced Rainbow Acoustic Monitoring, a noninvasive and continuous monitoring of acoustic respiration rate.

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