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Early detection breakthrough cleared by FDA!


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Sputum Induction Made Simple: the Lung Flute® Cleared by the FDA via 510(k)

by Barbara Kram, Editor

Buffalo, NY -- Medical Acoustics LLC announces its revolutionary new medical device, the Lung Flute®, has been cleared by the FDA for sputum induction for diagnostic purposes. This simple, hand-held, disposable device supplements the patient's natural mucus clearing system by introducing low frequency sound waves into the lungs. Asthma, chronic bronchitis, community acquired pneumonia and lung cancer are on the rise and becoming an increasing burden on the healthcare system. The Lung Flute® provides a simple and reproducible method for obtaining sputum samples, and will play a significant roll in the development of high-throughput diagnostic technologies for pulmonary diseases. Deep lung secretions can be obtained for identifying inflammatory response in asthma, infectious agents in pneumonia and biomarkers in lung cancer. Currently, sputum induction using hypertonic saline is the standard method. This process is expensive, time consuming, uncomfortable to the patient and frequently causing bronchial spasm and inflammation. As a result, sputum samples, using hypertonic saline, cannot be collected more frequently then every 48 hours. The Lung Flute® addresses these challenges and will allow sputum samples to be collected every 20 minutes which is important when monitoring inflammatory markers during asthma attacks.

Pulmonary research has been hampered over the past forty years by the lack of a convenient method of obtaining deep lung secretion samples even though the utility of the sputum sample is well documented. "Today the diagnostic industry, active in monitoring pulmonary health, has been handed a tool which will stimulate the development of diagnostic methods, especially in lung cancer markers." says Nicolaas Smit PhD, VP Science and Technology. "Currently, lung cancer research is a top national priority, with federal government mandating the development of early detection technologies. The Lung Flute® will be one of the technologies which will accelerate this effort."

Medical Acoustics, LLC is a New York based company built on nearly ten years of research and development in the area of applied acoustics. The company was formed in February 2002 to commercialize proprietary acoustic medical technology to assist in the diagnosis and treatment of a variety of human lung diseases. The company's mission is to design and develop devices employing acoustic technologies for diagnostic and therapeutic medical applications to be licensed to enterprises with global manufacturing, marketing, and distribution capabilities.

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