FDA Clears GE Healthcare's Non-invasive, Radiation-free Lung Imaging System
December 17, 2008
Anaheim, CA - GE Healthcare, the US$17 billion healthcare business of global technology, media and financial services company General Electric Company (GE), in partnership with Deep Breeze Ltd, the leader in vibration response imaging (VRI™) technology, today announced that the U.S. Food and Drug Administration (FDA) granted 510(k) marketing clearance for the VRIxv™, a non-invasive, radiation-free lung imaging system. The VRIxv™ will be on display at the 54th AARC International Respiratory Congress from Dec 13-16, in Anaheim, CA.
Responding to the market need for bedside monitoring of lung sounds, GE Healthcare and Deep Breeze Ltd. have designed the VRIxv™ to display comprehensive information during the respiratory process on ventilated patients. The VRIxv™ records lung sounds by utilizing acoustic sensors brought in contact with the patients' back while lying in bed. Sophisticated software converts signals into dynamic images of the lungs with regional distribution maps, numerical representation and breathing graphs. Each recording samples 20 seconds of lung sounds, typically covering several breath cycles. Moreover, monitoring capabilities are enhanced by synchronization of the VRIxv™ image and vibration energy graph, with the pressure and flow waveforms sampled from the ventilator. This synchronization helps to rapidly and objectively assess the recorded image.
"GE Healthcare is helping to facilitate the next era in patient care by providing to the clinical community not only a wide range of ventilation solutions, but also advanced respiratory monitoring tools - such as the VRIxv™, which provides a clinician with a window into what is happening inside the lungs in real time," said Pam Hall, General Manager for the Critical Care segment of the Respiratory and Sleep Business at GE Healthcare. "Our goal is to help clinicians efficiently monitor their patients' respiratory conditions and help clinicians tailor therapy to improve the outlook for every respiratory patient."
"The availability of the VRIxv™ device in the U.S. will allow the critical care community to effectively record and monitor the overall and regional distribution of lung sounds during the respiratory process," said Dr. R. Phillip Dellinger, professor of medicine at Robert Wood Johnson Medical School and Director of the Critical Care Division at Cooper University Hospital. "The VRIxv™ provides the physician with measurements that reveal changes in lung sounds, including changes due to therapeutic treatment, changes due to ventilator settings or changes due to the clinical conditions in mechanically ventilated patients."
"The FDA clearance of VRIxv™ advances our efforts to create a new clinical paradigm in which our VRI™ technology will be the standard application in a broad line of clinical applications, such as monitoring the impact of ventilator settings or managing risk associated with mechanically ventilated patients." said David Barton, President, Deep Breeze USA.
About GE Healthcare
GE Healthcare provides transformational medical technologies and services that are shaping a new age of patient care. Our expertise in medical imaging and information technologies, medical diagnostics, patient monitoring systems, performance improvement, drug discovery, and biopharmaceutical manufacturing technologies is helping clinicians around the world re-imagine new ways to predict, diagnose, inform, treat and monitor disease, so patients can live their lives to the fullest.
GE Healthcare's broad range of products and services enable healthcare providers to better diagnose and treat cancer, heart disease, neurological diseases and other conditions earlier. Our vision for the future is to enable a new "early health" model of care focused on earlier diagnosis, pre-symptomatic disease detection and disease prevention. Headquartered in the United Kingdom, GE Healthcare is a $17 billion unit of General Electric Company (NYSE: GE). Worldwide, GE Healthcare employs more than 46,000 people committed to serving healthcare professionals and their patients in more than 100 countries. For more information about GE Healthcare, visit our website at www.gehealthcare.com.
About Deep Breeze Ltd.
Founded in 2001, Deep Breeze is a privately owned medical device company backed by financial partners. A variety of Beep Breeze products, based on its innovative VRI™ technology, have being cleared for commercialization in the USA, Europe, China, Korea and Israel. In joint partnership with GE Healthcare, Deep Breeze introduced its Critical Care device in Europe in October 2007. Deep Breeze Ltd. is led by an international management team, with extensive experience in medical technologies and imaging, international marketing and operations, regulatory affairs and finance. The Company's Headquarters, Research and Development Center, are located in Or-Akiva Israel, with offices in the US, Germany and Asia-Pacific.