"When CTLM was used as an adjunct to mammography in heterogeneously dense breasts and extremely dense breasts the sensitivity increased significantly," Dr. Qi stated. "This study suggests that in clinical practice, adding CTLM in dense breasts may be useful."
Following the study's presentation at RSNA, it will be released in China, where it will be used to help market the CTLM system throughout the country.
The CTLM system has completed registrations including the CE Mark, CMDCAS Canadian License, China SFDA, UL, ISO 9001:2000, ISO 13485:2003 and FDA export certification.
Imaging Diagnostic Systems, Inc. has developed a revolutionary new imaging device to aid in the detection and management of breast cancer. The CTLM(R) system is a breast imaging system that utilizes patented continuous wave laser technology and computer algorithms to create 3-D images of the breast. The procedure is non-invasive, painless, and does not expose the patient to ionizing radiation or painful breast compression. CT Laser Mammography (CTLM(R)) 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 engaged in clinical trials for the FDA Pre-market approval application submission.
The FDA has determined that the Company's clinical study is a non-significant 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.'/>"/>
|SOURCE Imaging Diagnostic Systems, Inc.|
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