Medical Acoustics' Lung Flute Now Registered In The European Union
Buffalo, NY - Medical Acoustics LLC announced recently that it has successfully registered its Lung Flute as a Class 1 medical device for sale in the European Union. Medical Acoustics demonstrated conformity with essential health and safety requirements set out in European directives. It is now qualified to apply the CE mark (Conformité Européenne) for marketing the Lung Flute in the EU, both for diagnostic and therapeutic applications.
Medical Acoustics officially launched the Lung Flute within the European Union at MEDICA, the world's largest medical trade fair, in Dusseldorf, Germany, in November. Its strategy is to penetrate the EU market through leading medical device distributors, especially those that serve the pharmaceutical, medical and public health markets specializing in lung and respiratory diseases.
"The Lung Flute provides EU clinicians with a safe, easy-to-use means of obtaining high quality sputum samples for the improved diagnosis and treatment of a myriad of lung and respiratory diseases," said Terence Cryan, President of Medical Acoustics. "The applications for our device are far-ranging. They include, for example, public health officials using the Lung Flute to quickly and effectively gather sputum samples to screen for tuberculosis (TB), or even health clinics using it to clear the lungs of asthma patients. Our novel technology is now accessible to over 300 million people throughout the European Union."
The cost effective and easy-to-use device, which is shaped like a flute, creates a specific low-frequency sound when the user blows into it. This creates vibrations in the airways and lung which cause deep lung secretions to thin and be expelled.
The standard method for obtaining lung secretions for testing involves a person breathing hypertonic saline into their lungs. This method is very uncomfortable, and in addition, cannot be done more frequently than every 48 hours.
The Lung Flute makes treatment, testing and diagnosis, much easier for the provider; significantly more comfortable for the patient; and costs much less to use. In addition, it may be used much more often — up to every 20 minutes — for varied treatment options and more accurate biomarker testing.
SOURCE: Medical Acoustics LLC