A Buffalo medical device company has taken its therapeutic device to the next level with an application to the Food & Drug Administration.
Medical Acoustics LLC applied to the FDA for clearance of its therapeutic lung flute, a device designed for patients with respiratory illnesses such as chronic obstructive pulmonary disease (COPD).
The application for 510(k) clearance, a precursor to putting the product on the market, follows the successful completion of a clinical trial at the University at Buffalo and the Buffalo VA Medical Center. Led by principal investigator Dr. Sanjay Sethi, the clinical trial is intended to show the safety and effectiveness of the device in COPD patients with chronic bronchitis.
The lung flue – a handheld, reusable device – supplements a patient’s natural mucus-clearing system by introducing low-frequency sound waves into the lungs. The company expects the device to play a role in the diagnosis and development of treatments for lung cancer, tuberculosis, chronic bronchitis, asthma and pneumonia.
Medical Acoustics is a privately held, commercial stage company that designs and develops devices using acoustic technologies for diagnostic and therapeutic medical applications.