www.fdanews.com/articles/182213-fda-grants-clearance-to-qt-ultrasound-for-breast-imaging-device
FDA Grants Clearance to QT Ultrasound for Breast Imaging Device
June 14, 2017
QT Ultrasound has received FDA marketing clearance for its Transmission Wave Ultrasound breast scanner.
The scanner produces 360° images of the breast and eliminates the use of radiation and breast compression.
The breast scanner is not intended as a replacement for screening mammography.
The company has initiated a clinical trial program to determine its efficacy. — Cynthia Jessup