Healthcare Industry News:  cardiopulmonary 

Devices FDA

 News Release - August 9, 2007

FDA Clears Unique Non-Invasive, Radiation-Free Pulmonary Imaging System

Deep Breeze(TM) VRIXP(TM) Pulmonary Imaging System Records & Monitors Lung Sounds

OR-AKIVA, Israel, Aug. 9 (HSMN NewsFeed) -- Deep Breeze(TM), the leader in vibration response imaging (VRI(TM)) technology, today announced that the U.S. Food and Drug Administration (FDA) granted 510K marketing clearance for the VRIXP(TM), a non-invasive, radiation-free pulmonary imaging system to use 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(TM). "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(TM) in the U.S. at the 2007 CHEST meeting in Chicago, October 20 to 25. The Company currently markets the technology in Europe and Asia.

The non-invasive 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(TM) images appear on the system's computer screen.

The VRIXP(TM) 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. The radiation-free technology has been used in more than 3,500 patients worldwide without any single adverse event.

"The VRIXP(TM) 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," 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, said.

About Deep Breeze(TM)

Founded in 2001, Israel-based Deep Breeze(TM) (www.deepbreeze.com) is a privately-held medical device company that is providing advanced pulmonary imaging with its proprietary patented technology, Vibration Response Imaging (VRI(TM)). The Company is currently conducting clinical studies globally to evaluate VRI(TM) 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(TM) is researching and developing the VRI(TM) technology to be applied in other organs of the human body.



Source: Deep Breeze

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