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Jun 3, 2010

Deep Breeze : FDA CLEARS UNIQUE NON-INVASIVE, RADIATION-FREE PULMONARY IMAGING SYSTEM FOR AIDING IN DIAGNOSIS

Deep BreezeMay 30, 2010 — Deep Breeze™, the innovative company that has developed the Vibration Response Imaging (VRI™) technology, announced that the U.S. Food and Drug Administration (FDA) granted 510K marketing clearance for the VRIXP™, previously cleared for recording and monitoring lung sounds, as an Aid in Diagnosis and patient management when interpreted by physicians with general medical training and experience.
“The new FDA approval is the result of close to 10 years of research and development and clinical work, enabling adding to the visual presentation of VRI images, objective quantitative measures, amongst which is the automatic detection of adventitious lung sounds such as crackles and wheezes. This presents the physicians with a complementary tool to help in diagnosing respiratory disorders.”... [PDF] Deep Breeze's Press Release -