Israeli imaging startup Deep Breeze announced that the U.S. Food and Drug Administration has granted 510(k) clearance for the company's VRIXP system, a noninvasive, radiation-free pulmonary imaging system that uses sounds to create dynamic images of the lungs.
The system records lung sounds from sensors applied to a patient's back while he or she breathes, then applies 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 VRIXP images appear on the system's computer screen.
The 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 technology has been used in more than 3,500 patients worldwide without any adverse events, according to the company.
Deep Breeze plans to launch VRIXP in the U.S. at the 2007 Chest meeting in Chicago in October. VRIXP is currently marketed in Europe and Asia, the company said.
By AuntMinnie.com staff writers
August 9, 2007
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