Medical Acoustics, which employs acoustic technologies for diagnostic and therapeutic medical applications, has received FDA 510(k) clearance of its Therapeutic Lung Flute.
The company claims that the trial, designed to demonstrate the safety and effectiveness of the Therapeutic Lung Flute was completed with the Lung Flute meeting all primary and secondary endpoints among patients with chronic obstructive pulmonary disease (COPD) with chronic bronchitis.
The simple, hand-held, reusable therapeutic device supplements the patient’s natural mucus clearing system by introducing low frequency sound waves into the lungs.
Terence Cryan, president of Medical Acoustics, said: “Our recent clinical trial has shown that the Therapeutic Lung Flute effectively helps COPD patients clear respiratory tract secretions, which results in an improved quality of life. For the more than 16 million Americans diagnosed with COPD, this FDA 510(k) clearance is very good news.
“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.”