ATL'S HIGH DEFINITION BREAST IMAGING GETS PANEL ENDORSEMENT FOR USE IN DIFFERENTIATING LESIONS; PANEL ASKS FOR DATA ON BIOPSY REDUCTION CLAIM
This article was originally published in The Gray Sheet
Executive Summary
Advanced Technology Laboratories' High Definition ultrasound imaging provides "a high level of confidence" in distinguishing benign from malignant or suspicious breast lesions, but the technology should not be labeled as being able to "diagnose" benign lesions, FDA's Radiology Devices Advisory Panel concluded at a Dec. 11 meeting in Gaithersburg, Maryland.