FDA Grants Marketing Clearance for Pulmonary Imaging System

OR-AKIVA, Israel /PRNewswire/ -- Deep Breeze, a leader in vibration-response imaging (VRI) technology, announced that the U.S. Food and Drug Administration (FDA) granted 510K marketing clearance for VRIXP, a noninvasive, radiation-free pulmonary imaging system that uses lung sounds to create dynamic images of the lungs.

"Vibration-response imaging enables physicians to effectively record and monitor lung sounds with the ultimate goal of improving the detection and assessment of lung disorders in the future," said Igal Kushnir, MD, President and CEO of Deep Breeze. "FDA clearance represents a significant milestone for the company, and we plan to work closely with U.S. interventional pulmonologists to bring this advanced pulmonary imaging system to patients suffering from lung disorders."

Deep Breeze plans to launch VRIXP in the U.S. at the 2007 CHEST meeting in Chicago, October 20-25. The company currently markets the technology in Europe and Asia.

The noninvasive and radiation-free lung imaging system records lung sounds from sensors applied to a patient's back while he or she breathes. The system then uses an algorithm to convert these data into images. Changes in tissue composition or alteration in airflow impact how sounds within the lungs vibrate and, subsequently, how the VRIXP images appear on the system's computer screen.

The VRIXP procedure takes only minutes in a physician's office and may be performed repeatedly for continuous monitoring. Results are delivered to the physician immediately and can be stored in a system database for future use. More than 3500 patients have used the radiation-free technology worldwide without a single adverse event.

"The VRIXP system is a breakthrough technology that may allow us to improve patient care by providing more detailed and rapid assessment of lung status without exposing the patient to radiation," said Kalpalatha K. Guntupalli, M.D., Professor of Medicine, Chief, Pulmonary, Critical Care, and Sleep Medicine, Baylor College of Medicine.

"This technology shows great promise for assisting in the care and management of critically ill patients as well as patients with a wide variety of acute cardiopulmonary problems," said Dr. R. Phillip Dellinger, Professor of Medicine at Robert Wood Johnson Medical School and Director of the Critical Care Division, Department of Medicine, Cooper University Hospital.

About Deep Breeze
Founded in 2001, Israel-based Deep Breeze is a privately held medical-device company that is providing advanced pulmonary imaging with its proprietary, patented technology, VRI. The company is currently conducting clinical studies globally to evaluate VRI efficacy in fields such as general pulmonology, chronic obstructive pulmonary disease, asthma, congestive heart failure, interventional pulmonology, lung cancer, lung transplant, and critical care patient management. Deep Breeze is developing the application of VRI technology with other organs of the human body.

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