Bloomberg NEWS: Chinese Dr. Qi's Research about CTLM
Imaging Diagnostic Systems CT Laser Mammography (CTLM(R)) System
Imaging Diagnostic Systems CT Laser Mammography (CTLM(R)) System Featured at the 94th Annual Radiological Society of North America (RSNA) Conference
PR Newswire
FORT LAUDERDALE, Fla., Dec. 1
FORT LAUDERDALE, Fla., Dec. 1 /PRNewswire-FirstCall/ -- Imaging Diagnostic Systems, Inc., (OTC Bulletin Board: IMDS), a pioneer in laser optical breast imaging, announced today that a recent study on CTLM is one of the featured scientific abstracts at RSNA 2008, November 30th - December 5th. Dr. Jin Qi, a radiologist at the Tianjin Medical University Cancer Institute and Hospital, Tianjin, China, was selected for her paper, "CTLM as an Adjunct to Mammography in the Diagnosis of Patients with Dense Breasts." Dr. Qi is attending RSNA with IDSI and will be present at the company's exhibit.
Her study, which evaluated CTLM as an adjunct to mammography in women with heterogeneously or extremely dense breast tissue, found that CTLM could successfully distinguish malignant from benign lesions in dense breasts. The system's imaging capabilities were not affected by tissue density in breasts and could provide information about angiogenesis in malignant and benign breast lesions.
Women who were scheduled for biopsy were first evaluated with mammography to classify breast density and then examined by the CTLM system. The CTLM examination was performed subsequently with mammography. The findings were then compared to mammography alone, the CTLM system alone, and CTLM and mammography adjunctively. Sensitivity, specificity, and positive predictive values were calculated by using standard methods. Among the extremely dense breast patient population, the sensitivity of mammography alone was 34.40%. CTLM alone resulted in a sensitivity of 74.40%, and mammography plus CTLM produced a sensitivity of 81.57%. The specificity of mammography alone was 90.48%; CTLM alone, 71.00%; and mammography plus CTLM was 72.22%.
In the heterogeneously dense breast patient population, the sensitivity of mammography alone was 68.29%; CTLM alone was 85%; and mammography plus CTLM resulted in a sensitivity of 95.34%. The specificity of mammography alone was 85%. CTLM alone was 61% and mammography plus CTLM was 55.26%.
"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.
Blue, thanks for posting that and making my point.
There's NOTHING in front of the FDA to approve. There's just a promise that they're "committed". Commmitted? It's been almost a year since they were REJECTED BY THE FDA for that 1/2-butted FAILED attempt at the 510(k) and they've accomplished NOTHING with the FDA in all that time. Not even the meeting they promised. Why not? How's that "Committed"??
Furthermore, I believe because of their admitted LACK OF FINANCING, there will NEVER be anything in front of them to approve.
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