XILLIX LIFE-LUNG AS AID IN CANCER DIAGNOSIS RECOMMENDED FOR APPROVAL; DEVICE DOUBLES NUMBER OF CANCER PATIENTS DIAGNOSED BY STANDARD BRONCHOSCOPY
This article was originally published in The Gray Sheet
Executive Summary
The benefits of detecting additional lung cancer lesions with Xillix' Life-Lung device outweigh the additional false positive results that it generates, FDA's Ear, Nose and Throat Devices Panel concluded at a June 11 meeting in Rockville, Maryland. The panel voted unanimously to recommend approval with conditions of Xillix' premarket approval application for use of the fluorescence imaging device as an adjunct to white light bronchoscopy (WLB) in diagnosing lung cancer.