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Concept
The VRI™ technology is based on Vibration Response generated by the air passing through the lungs. The system records these vibrations and then uses an algorithm to convert the data into images. Changes in tissue composition or alteration in airflow impact how sounds within the lungs vibrate, and subsequently how the images by the VRI™ system appear on the system’s computer screen. The result offers physicians a dynamic functional lung image together with quantitative data, obtained passively at the bedside & without radiation. Thousands of patients have been recorded by the VRI™ system worldwide during clinical investigations without any single adverse
event.
The VRI™ system was granted the CE mark in September 2005, received the Medical Device
and Accessories approval by the Israeli Minister of Health in January 2006, the Korean Food and Drug Administration Approval in January 2007, and the FDA 510K clearance via the pre-market
notification process for Marketing in the USA in August 2007 and approval of registration by the State Food and Drug Administration (SFDA) of the People's Republic of China in January 2008.
Deep Breeze Ltd. is ISO 13485 Medical Devices Quality Management Systems certified.
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