Medical Acoustics LLC, Buffalo, NY, a commercial-stage medical device company, received 510(k) clearance from the US Food and Drug Administration (FDA) for its Therapeutic Lung Flute®.
The Therapeutic Lung Flute, a hand-held, reusable therapeutic device, supplements the patient’s natural mucus clearing system by introducing low frequency sound waves into the lungs.
The 510(k) clearance follows the successful completion of a 2009 clinical trial designed to demonstrate the safety and effectiveness of the Therapeutic Lung Flute, led by principal investigator Sanjay Sethi, MD, from the University at Buffalo, NY. At the conclusion of the trial the Lung Flute met all primary and secondary endpoints among patients with chronic obstructive pulmonary disease (COPD) with chronic bronchitis.
“The Lung Flute is a safe, effective, low cost, and patient friendly method for patients with COPD to maintain their respiratory health through regular use. Our clinical trial results indicate that the Lung Flute has the potential to make a lasting positive impact on the quality of life of tens of millions of COPD sufferers worldwide,” reports Terence Cryan, president of Medical Acoustics., in a recent press release.
