Deep Breeze Wins FDS OK for Imaging System

Deep Breeze of Or-Akiva, Israel, has received 510(k) clearance from the FDA for its VRIXP, a noninvasive, radiation-free pulmonary imaging system. The system mathematically analyzes sounds created during breathing — measured using sensors applied to a patient’s back — to generate dynamic images of the lungs. Changes in tissue composition or air flow appear in the images, allowing detection and assessment of potential lung disorders. The device is on the market in Europe and Asia.