Thursday, July 1, 2010

FDA Clears Masimo’s Pronto-7

Masimo Corp. (MASI: 23.81 0.00 0.00%) recently announced that it has got clearance from the Food and Drug Administration (FDA) for its Pronto-7, a handheld device intended for fast, convenient, and non-invasive spot check testing of hemoglobin, as well as measurement of pulse rate and other key parameters. Masimo’s device can be flexibly used in different settings. 
 
The Pronto-7 from Masimo possesses superior communication capabilities that simplify wireless printing and e-mailing of results. It is the first Masimo device to utilize the company’s proprietary Rainbow 4D technology. Masimo plans to integrate Pronto-7 with Electronic Health Record (EHR) systems.    
 
Anemia or a low hemoglobin level is a common blood disorder. According to the World Health Organization, anemia afflicts about 1.6 billion people globally and leads to approximately 1 million deaths every year. It is among the top ten risk factors leading to incidence of disease and negatively impacts the global gross domestic output by an estimated $50 billion.
 
Anemia may either be in chronic or acute state. In acute anemia, the patient experiences a sudden decline in hemoglobin levels due to loss of blood following surgery or trauma. In chronic anemia, on the other hand, hemoglobin levels are at a low level due to illness or dietary deficiency.   
 
Measurement of hemoglobin, in different medical settings, is frequently required to assess anemia and blood loss. Traditional lab testing for hemoglobin involves a somewhat painful withdrawal of blood from the patient followed by a time lag before results are available for the doctor.
 
Pronto-7, on the other hand, will deliver results in less than a minute, while avoiding certain negative consequences such as unnecessary usage of needles, lab analysis, patient discomfort, possibility of blood contamination and handling of hazardous waste.



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