CT Laser Mammography Shown to Improve Mammography Sensitivity

New computed tomography laser mammography (CTLM) technology utilizes patented continuous wave laser technology and computer algorithms to create three-dimensional (3D) images of the breast. The procedure is noninvasive, painless, and does not expose the patient to ionizing radiation or painful breast compression

Imaging Diagnostic Systems, Inc. (Fort Lauderdale, FL, USA), a developer of laser optical breast imaging systems, presented CTLM clinical results at the annual European Congress of Radiology (ECR 2009), March 6-10, 2009, in Vienna, Austria.

The clinical study was from the Tianjin Medical University Cancer Institute and Hospital (Tianjin, China). The study demonstrated, "when the CTLM system was used as an adjunct to mammography in heterogeneously and extremely dense breasts, the sensitivity [detecting cancer] increased significantly."

Imaging Diagnostic developed the innovative new imaging device to aid in the detection and management of breast cancer. The technology 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 U.S. Food and Drug Administration (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 in the United States to investigational use only in the United States.

Related Links:
Imaging Diagnostic Systems
Tianjin Medical University Cancer Institute and Hospital