Deep Breeze gets FDA 510(k)

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Vibration response imaging technology developer Deep Breeze of Or-Akiva, Israel, said that it has been granted 510(k) marketing clearance by the U.S. Food and Drug Administration for its VRIXP device, a non-invasive, radiation-free pulmonary imaging system that uses sound 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. It then uses an algorithm to convert these 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, according to Deep Breeze.

The company currently markets the technology in Asia and Europe and will be introducing it to the U.S. at the 2007 Chest meeting in Chicago this October.