FDA go-ahead for Medical Acoustics' Lung Flute
This article was originally published in Clinica
Executive Summary
Medical Acoustics' therapeutic Lung Flute has received 510(k) clearance from the US FDA. The hand-held device is intended for chronic obstructive pulmonary disease (COPD) patients, and supplements natural mucus clearing systems by introducing low-frequency soundwaves into the lungs, which increases mucociliary clearance. A recent clinical trial in COPD patients with chronic bronchitis met all its primary and secondary endpoints, the company said. Buffalo, New York-based Medical Acoustics will begin taking orders for the product on February 1 at a cost of $40. It CE marked the Lung Flute, which can also be used to obtain sputum samples for diagnostic purposes, for sale in Europe in December 2007.