Imaging Diagnostic Systems Introduced New Laser Breast Imaging Scanner
Laser Breast Imaging Scanner
Imaging Diagnostic Systems has shipped a CT Laser Mammography (CTLM) system to the Universiti Putra Malaysia (UPM) in Kuala Lumpur, Malaysia, the first such scanner in the country.
The CTLM system will be installed at UPM's academic facility within the jurisdiction of the Ministry of Education and will be evaluated by specialists from UPM in conjunction with specialists from Serdang Hospital in Kuala Lumpur.
An IMDS spokesperson said, "We are pleased to add Malaysia to those areas in Asia where CTLM is being considered as a possible solution for improving the diagnosis and management of breast cancer cases. UPM is very forward- looking and, we believe, focused on improving women's health services through advanced technologies."
The CTLM system is expected to be in service by Oct 1st.
About Imaging Diagnostic Systems, Inc.
Imaging Diagnostic Systems, Inc. has developed a revolutionary new imaging device to aid 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 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) 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.
Imaging Diagnostic Systems is currently collecting data from clinical sites for the future filing of an FDA Premarket Approval (PMA) for the Computed Tomography Laser Mammography (CTLM) system to be used as an adjunct to mammography. 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. The CTLM system has received other registrations including CE, CMDCAS Canadian License, China SFDA, UL, ISO 9001:2000, ISO 13485:2003 and FDA export certification.