Medical start-up Deep Breeze Ltd. today announced that it has received a CE mark, declaring its vibration response imaging (VRI) system, called VRI(XP), "safe and effective". Receipt of the CE mark allows the company to market the technology to physicians in European Union countries.
VRI(XP) provides physicians with a dynamic image of the lungs, delivering both structural and functional information to aid in assessing lung condition.
Professor Mordechai Kramer is performing clinical trials at the Pulmonary Institute at Rabin Medical Center, which is affiliated with the Sackler School of Medicine at Tel-Aviv University.
"The VRI(XP) system adds a new dimension to interventional pulmonology and evaluation of patients with lung transplants," said Professor R. Kramer. "We will be able to assess lung function much more effectively and non-invasively".
The VRI(XP) system received the CE mark after an audit, which found the device safe and effective to use, and approved it as a lung diagnostic device.
Deep Breeze CEO and founder Dr. Igal Kushnir said, "We are introducing a new imaging technology for the human body, which is radiation-free and organ oriented. Unlike magnetic resonance imaging (MRI), X-ray or ultrasound, VRI utilizes passive vibration energy that is naturally created in organs to produce a dynamic image of the organ. The development of the first VRI for the lungs was based on the finding that the lung vibration energy directly correlates to the lung airflow. VRI displays for the first time a dynamic image of the lungs as they function".
First deliveries of the VRI(XP) are expected in the fourth quarter of 2005.
The system is currently in use at sites in Europe, the US and Israel. Deep Breeze is conducting clinical studies globally, evaluating VRI(XP) efficacy in critical care patient management, interventional pulmonology, and monitoring of asthma, congestive heart failure and lung transplant patients. The VRI(XP) is not approved for sale in the US.
The VRI(XP) system will be on display for the first time in Europe at the European Respiratory Society meeting in Copenhagen, Denmark, September 17-21, 2005.
Privately-held Deep Breeze was founded in 2001 and maintains its corporate headquarters, research and development laboratories, and manufacturing facility in Or-Akiva, Israel.
Published by Globes [online], Israel business news - www.globes.co.il - on Wednesday, September 14, 2005