March 11, 2009 – When CT Laser Mammography (CTLM) is used as an adjunct to mammography in heterogeneously and extremely dense breasts, the sensitivity increases significantly, according to results from a study presented at the annual European Congress of Radiology (ECR 2009), March 6-10, in Vienna, Austria.
The clinical study was conducted at the Tianjin Medical University Cancer Institute and Hospital, Tianjin, China.
Imaging Diagnostic Systems, the developer of laser optical breast imaging systems, exhibited its CTLM system at ECR. The imaging device aids in the detection and management of breast cancer. The CTLM system is a breast imaging system that utilizes patented continuous wave laser technology and computer algorithms to create 3D images of the breast. The procedure is noninvasive, painless and does not expose the patient to ionizing radiation or painful breast compression. CTLM is designed to be used in conjunction with mammography. It reveals information about blood distribution in the breast and may visualize the process of angiogenesis, which usually accompanies tumor growth.
The company is currently undergoing the clinical studies required for the Premarket approval application. The FDA has determined that the Company’s clinical study is a nonsignificant risk (NSR) investigational device study under 812.3(m) of the investigational device exemptions (IDE) regulation (21 CFR 812). The CTLM system is limited by United States Federal Law to investigational use only in the United States.
For more information, visit our website: www.imds.com