FDA Clears Radiation-Free Pulmonary Imaging System

Deep Breeze announced that the FDA granted 510(k) marketing clearance for the VRIXP, a noninvasive, radiation-free pulmonary imaging system to use lung 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. The system 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.

The VRIXP procedure can be accomplished in minutes and may be performed repeatedly for continuous monitoring, the company said. Results are delivered to the physician immediately and can be stored in a system database for future use.

Deep Breeze said it plans to launch VRIXP in the U.S. in 2007. The company currently markets the technology in Europe and Asia.