FDA Clears VRIxp, A Non-Invasive, Radiation-Free Pulmonary Imaging System, For Aiding In Diagnosis And Patient Management
Deep Breeze™ VRIXP™ Pulmonary Imaging System Records & Monitors Lung
Sounds
OR-AKIVA, Israel (May 30, 2010)—Deep Breeze™, the innovative company that has
developed the Vibration Response Imaging (VRI™) technology, announced today 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.” said Michael Nagler, PhD, CEO of Deep
Breeze™. “The FDA clearance for Aid in Diagnosis represents a significant milestone for
the Company enabling positioning VRI™ technology as an additional and novel
diagnostic aid in the physician’s toolbox, alongside other imaging modalities such as XRay
and Ultrasound. This new clearance opens the way for the VRIxp™ system to be
sold for use in a wide range of applications.”
The non-invasive and radiation-free imaging system records lung sounds created by the
breathing process using an array of proprietary, patent protected sensors applied to the
patient’s back. The system then uses proprietary algorithms to convert these data into
dynamic images presenting lung function and into quantitative information that the
physician can use in making treatment decisions. Changes in tissue composition or
alteration in airflow impact the characteristics of sounds generated by lung tissue
vibrations and, subsequently, affect how the VRIxp™ images and quantitative data appear
on the system’s computer screen. Comparison of repeated images and quantitative lung
sounds data provide information about changes in the lungs over time or following
treatment.
“The radiation-free VRIxp™ procedure takes only minutes in a physician’s office and
may be performed repeatedly for continuous monitoring and now also to help in
diagnosing patients with respiratory diseases. Results are delivered to the physician
immediately and can be stored in a system database for future use. The technology is
being used at more than 150 sites, many at leading institutions all over the world in a
variety of applications. More than 5,000 patients worldwide have been recorded to date,
without any adverse events.” comments David Barton, President of Deep Breeze, Inc.,
the US arm of the company tasked with commercialization of the product.
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, Vibration Response Imaging (VRI). The Company has conducted clinical studies globally to evaluate VRI efficacy in fields such as: general pulmonology, COPD, CHF, asthma, interventional pulmonology, lung cancer, lung transplant and critical care patient management, and is continuing to invest in clinical research for the purpose of expanding its product offering including now —home use for monitoring patients with chronic disease.
For additional information, please visit our website: www.deepbreeze.com or contact us:
Deep Breeze
Tel: +1 262‐719‐2056
Email: Jackie.Stetina@deepbreeze.com
Tel: +972‐(0)4‐656 6650
Email: Doran.Rozen@deepbreeze.com
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